Clinical Data on Bioback - Painezee India

1. By Medolutions, LLC
THE MOST COMFORTABLE NAME IN BACK PAIN RELIEF
Dear Doctor:
Thank you for your consideration of the Bio-Back lumbar Orthosis in your treatment of low back
conditions. An advancement of an age old technology, the Bio-Back is not a variation of every
other brace design that's been around for 50 years, big, bulky, and restrictive. Patients love the
Bio-Back and they actually wear it! Bio-Back is:
• A safe, drug-free alternative for treating LBP.
• A functional brace that helps your patients regain mobility and strength while reducing pain
to promote an active lifestyle.
• Comfortable and easy to use, which results in better patient compliance for improved clinical
outcomes.
The Bio-Back combines innovative and patented design features with an incredibly small, low
profile, size to immediately provide support and improve posture. Bio-Back’s unique
counter-force pressure changes muscle tone and reduces the stress on pain sensitive structures
(muscles, discs, joints, and nerves) in the lower back to help relieve pain and restore function
for acute, sub-acute and chronic low back pain sufferers.
The Bio-Back may be appropriate in treating the following conditions:
Strain/sprains of the lower back
Ruptured, Herniated, Bulging, Prolapsed disc conditions
Unstable joint mechanical conditions in the lower back
Weak or deconditioned lower back spinal muscles
Inflammatory arthritic conditions of the spine
Degenerative disc and joint disease
Spondylolisthesis and Spondylolsis
Osteoporosis conditions of the spine
Mechanical low back pain
Bio-Back uses easily adjustable straps to allow one size to fit most patients
• Standard Size fits 22” and 50” waists
• A second larger size is available for patients with 51” to 78” waists
• Smaller front panels can be provided, upon request, for your very petite patients.
• Once familiar with fitting, the Bio-Back can be adjusted for a patient within minutes
The Bio-Back should be worn comfortably tight to encourage a neutral spine posture and
to attain the best results. The Bio-Back may be worn while sitting, standing, sleeping, driving
or performing other daily activities. Please review the fitting instructions DVD provided with
the Bio-Back or available on our website at www.medolutions.com.
Bio-Back encourages activity to
help the patient return to a more
active, healthier lifestyle,
making Bio-Back an effective
complement to your treatment
of low back conditions for
improved functional outcomes.

2. By Medolutions, LLC
Bio-Back Patient Benefits
Decreases Lower Back Pain
Decreases Inflammatory Reaction
Decreases Intervertebral and Joint Pressure
in the Lower Back Region
Promotes Core Stability and Neutral Spine
Posture-providing for improved body
mechanics
Helps Improve Functional Outcomes
Increases Lower Back Range of Motion
Stabilizes Lower Back
Enables Lower Back Pain Suffers to Pursue
the Activities of Daily Living with Less
Back Pain
Enclosed please find information regarding the Bio-Back along with other studies regarding the
use of bracing, to include:
• Explanation of the Bio-Back’s Efficacy,
• Bio-Back Needle EMG Study (Abstract),
• Bio-Back Patient Evaluation Survey Results (Pain Management Patient Survey)
• Bio-Back Awarded National Organizations Seal of Approval (Press Release)
• Copy of Official Disability Guidelines regarding lumbar supports,
• Excerpt of Study information (Evidence Based Prevention and Rehabilitation, Stuart Mcgill)
• Study: Effectiveness of a lumbar belt in subacute low back pain (Calmels, 2009),
• Study: The Influence of Prophylactic Orthoses on Abdominal Strength and Low Back Injury
in the Work Place (Walsh 1990),
• Study: Lumbar Supports and Education for the Prevention of Low Back Pain in Industry
(Van Poppel & Colleagues 1998),
• Study: Lumbar Supports to Prevent Recurrent Low Back Pain among Home Care Workers
(Roelofs & Colleagues 1997)

3. By Medolutions, LLC
Explanation of Bio-Back’s Efficacy
Bio-Back’s design features relieve pain, promote a neutral spine posture and restore function.
The Bio-Back’s design features include:
• Bi-Lateral Opposing Forces combined with a Lumbar Dome that fits into the small of the back
• A pair of straps that connect two panels (front and back) that tighten the brace against the
patient’s abdomen and lower back
• Compact design that allows near total range of movement to promote patient compliance and
comfort
Clinical Effect Explanation / Benefit
Improves Posture The Bio-Back’s Bi-Lateral Opposing Forces and Lumbar Dome promote a neutral
spine posture for improved body mechanics during lifting, bending and other ADL’s.
Reduces Strain on and
Changes Tone of Low
Back Musculature
Bio-Back actively engages the abdominal muscles to balance the strain across the
core, thereby reducing the stress placed upon the low back musculature.
Needle EMG demonstrated that use of the Bio-Back orthosis, tensioned to 16 pounds
on patients standing in a neutral spine position, reduced low back muscle activity by
an average of 46% overall. The two muscle groups tested were the Longissimus and
the Multifidus with the following specific reductions in muscle activity:
• The Longissimus at L4 by an average of 51%
• The Multifidus at L4 by an average of 38%
Reduces the Load on
Intervertebral Discs and
Facet Capsular Joints
By changing the tone or reducing the activity of low back musculature and
promoting neutral spine posture the Bio-Back reduces the load placed on the
intervertebral discs and facet capsular joints.
Helps Stabilize the
Lower Back while in an
Injured State
The Bio-Back’s counter force pressure enhances joint stability in the lumbar spine
for improved functional training.
Relieves Pain The effects of changing the muscle tone and reducing the load on the intervertebral
discs and facet joints is to reduce the inflammatory reaction, resulting in back pain
relief.
A Pain Management Clinic conducted a subjective study of twenty-nine (29) low
back pain sufferers, who wore the Bio-Back for varying lengths of time (one month
to one year), reported the following results:
• 78% reported pain relief
• 73% reported pain prevention
• 7% reported a decrease in consumption of opioids
• 84% would recommend the Bio-Back
Helps Restore Function The Bio-Back with its unique counter force design helps restore the lumbar spine’s
ability to function in a normal or near normal manner by relieving pain and
improving posture to encourage more ergonomically correct motions. Thus, Bio-
Back can be utilized effectively in a rehabilitative fashion for numerous lower back
conditions.
Patient evaluations have demonstrated improvements in range of motion to the point
of increased pain of between 10% and 30% in acute and sub-acute low back pain
sufferers.

4. The effect of a novel lumbar orthosis on paraspinal muscle
activity: a pilot study
Charles W. Lindquist Jr. D.C. DACNB
Correspondence:
Frederick M. Graff, D.C. DABCO, Medical Director
Medolutions, LLC
Telephone: (614) 543.1743, ext 102
Email: fgraff@medolutions.com
ABSTRACT
Modifying the activity and improving the endurance of lumbar musculature during
dynamic and static activities is a key component of treatment for low back pain. This
paper presents a pilot study assessing the effect of a novel lumbar orthosis on lumbar
muscle activity. Nine asymptomatic volunteers (7 males and 2 females) ranging in age
from 22 to 55 years were recruited and six subjects were included in the final analysis.
The electromyographic (EMG) signals of the paraspinal muscles at the L4 vertebral level
were assessed while participants stood in a neutral position with or without the orthosis.
When wearing the orthosis, the electrical muscle activity was reduced by 51.3% (p=.03)
and 38.8% (p=.09) for longissimus and multifidus muscles, respectively. Collectively,
use of the orthosis reduced the activity of the paraspinal musculature by 46.2% (p<.05).
This pilot study suggests that this novel orthosis may provide external stability to the
spine and relieve muscle strain by reducing the recruitment of the paraspinal muscles.
Further well-controlled outcomes studies are needed to validate the effectiveness of this
orthosis in a large symptomatic patient population.
Study Design: Used electromyographic (EMG)
signals to measure paraspinal muscle activity at the
L4 vertebral level, pre and post utilization of a novel
lumbar orthosis.
Objective: The orthosis evaluated utilizes a unique
and patented design and has been subjectively
demonstrated to help relieve pain.
Electromyography was utilized to determine the
effect of this orthosis on paraspinal musculature.
Summary of Background Data: There is
limited evidence of efficiency of lumbar supports
for treatment of low back pain.
Results: When wearing the lumbar orthosis, the
mean electrical muscle activity was reduced for the
paraspinal muscles by an average of 46.2% (95% CI
-5.6, 45.2).
Conclusion: This pilot study provides initial data
on the effectiveness of a novel lumbar orthosis at
reducing paraspinal muscle activity. The decreased
EMG activity may provide temporary symptomatic
relief to patients suffering from low back pain.
Key words: lumbar, orthosis, back pain, muscle
endurance, electromyographic signal.
EMG muscle activity for longissimus and
multifidus with and without an orthosis.
Error bars represent one standard deviation.
0
10
20
30
40
50
60
70
No Othosis Orthosis
Conditions
Spikes/sec
longissimus
multifidus

5. Patient Evaluation of the
Bio-Back Lumbar Orthosis
for low back pain relief and pain prevention
April 2008

6. Patient Evaluation of the Bio-Back Lumbar Orthosis for low
back pain relief and pain prevention
Purpose
This study was performed by the medical staff at Pain Control Consultants, Inc; a
pain management practice located in Columbus Ohio, during April 2008. The
study was performed to obtain patient feedback regarding their use of and
experience with the Bio-Back lumbar orthosis.
Method and Subjects
Twenty-nine symptomatic patients suffering from chronic back pain were asked
to respond to a series of questions regarding their utilization of the Bio-Back
lumbar orthosis. These patients had used the Bio-Back for varying lengths of
time, but for not less than thirty days.
Results
Summary of patient responses:
o Seventy-eight (78%)
percent reported pain
relief,
o Seventy-three (73%)
percent reported pain
prevention,
o Seven (7%) percent
reported a decrease in
consumption of
opioids, and
o Eighty-four (84%)
percent would
recommend the Bio-
Back.
Conclusions
While subjective, this study demonstrates that for most patients, use of the Bio-
Back orthosis will provide pain relief for low back pain and will also help prevent
low back pain from occurring. It was very interesting to note that seven percent
of the patients indicated a decrease in the consumption of opioids indicating that
for low back pain patients, the Bio-Back may provide a useful tool in reducing
narcotic utilization.
Reported Pain
Relief
Reported Pain
Prevention
Reported Decreased
Opiod Usage
Will Recommend
the Bio-Back
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
Subjective Study of Chronic Back Pain Sufferers

7. Congress of Chiropractic State Associations (COCSA) Grants Bio-Back
Lumbar Orthosis Their Seal of Approval
| 29 Apr 2010 | 01:40 PM ET
DUBLIN, Ohio, April 29, 2010 /PRNewswire via COMTEX/ -- COCSA and Medolutions, LLC are pleased to announce that the Bio-Back Lumbar Orthosis has been
awarded the COCSA Seal of Approval. The patented Bio-Back is a licensed product of Medolutions, LLC and is clinically proven to help relieve back pain and
restore function. The Bio-Back's small, light-weight design makes it an effective tool in the treatment of low back pain.
About COCSA The Congress of Chiropractic State Associations was founded in 1969 with the mission of providing an open nonpartisan forum for the
advancement of the chiropractic profession through service to its member state associations. The COCSA Seal of Approval is granted to products or services
deemed to have exceptional value to our state association members or the chiropractic profession. In speaking of the Bio-Back, First Vice President Dr. Kate
Rufolo said, "On behalf of the Board, let me say that the Bio-Back represents the best of what is out there to improve the profession and to benefit our patients.
We look forward to working with Medolutions." Additional information about COCSA is available at http://www.cocsa.org.
About Medolutions (Photo: http://www.newscom.com/cgi-bin/prnh/20100429/CL95771 ) Medolutions was founded in 2007 to develop a line of pain relief
products based on unique and patented design architecture. The Company's initial product is the Bio-Back, with patented features that include "Bilateral
Opposing Forces" and a "Lumbar Dome". Together these features help relieve back pain and restore range of movement to improve functional outcomes. The
Bio-Back is clinically proven, healthcare reimbursed and provides an effective, drug free and complementary device for the treatment of a wide variety of low
back conditions. Medolutions President and CEO, Richard J. Gerace said, "We are very pleased to be associated with COCSA whose mission is vital to the
chiropractic profession. Their Board is represented by dedicated professionals who strive for the advancement of the profession, their membership and the
patients served. Additional information about Medolutions and the Bio-Back may be found at www.medolutions.com.
For additional information regarding this press release, please submit inquires to COCSA at amy4hardin@yahoo.com or submit inquires to Medolutions at
pr@medolutions.com.
SOURCE Medolutions www.prnewswire.com Copyright (C) 2010 PR Newswire. All rights reserved -0- KEYWORD: Ohio INDUSTRY KEYWORD: HEA
MEQ
URL: http://www.cnbc.com/id/36852906/
.
© 2010 CNBC.com
PR Newswire
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11. SPINE Volume 34, Number 3, pp 215–220
©2009, Lippincott Williams & Wilkins
Effectiveness of a Lumbar Belt in Subacute Low
Back Pain
An Open, Multicentric, and Randomized Clinical Study
Paul Calmels, PhD, MD,* Patrice Queneau, MD,† Claude Hamonet, PhD, MD,‡
Claude Le Pen, PhD,§ Frederique Maurel,§ Claire Lerouvreur,§
and Philippe Thoumie, MD, PhD¶
Study Design. Multicentric, randomized, and con-
trolled study of clinical evaluation of medical device in
subacute low back pain.
Objective. To evaluate the effects of an elastic lumbar
belt on functional capacity, pain intensity in low back pain
treatment, and the benefice on medical cost.
Summary of Background Data. There is limited evi-
dence of efficiency of lumbar supports for treatment of
low back pain. There is also a lack of the methodology in
the studies reported on the efficiency of this device.
Methods. This study is randomized, multicentric, and
controlled with 2 groups: a patient group treated with a
lumbar belt (BWG) and a control group (CG). The main
criteria of clinical evaluation were the physical restoration
assessed with the EIFEL scale, the pain assessed by a
visual analogic scale, the main economical criteria was
the overall cost of associated medical treatments.
Results. One hundred ninety-seven patients have par-
ticipated. The results show a higher decrease in EIFEL
score in BWG than CG between days 0 and 90 (7.6 Ϯ 4.4
vs. de 6.1 Ϯ 4.7; P ϭ 0.023). Respectively significant re-
duction in visual analogic scale was also noticed (41.5 Ϯ
21.4 vs. 32.0 Ϯ 20; P ϭ 0.002). Pharmacologic consump-
tion decreased at D90 (the proportion of patients who did
not take any medication in BWG is 60.8% vs. 40% in CG;
P ϭ 0.029).
Conclusion. Lumbar belt wearing is consequent in
subacute low back pain to improve significantly the func-
tional status, the pain level, and the pharmacologic con-
sumption. This study may be useful to underline the in-
terest of lumbar support as a complementary and
nonpharmacologic treatment beside the classic medica-
tion use in low back pain treatment.
Key words: low back pain, lumbar belt, pain, func-
tional assessment, economical assessment. Spine 2009;
34:215–220
Low back pain is a very frequent symptom in industrial-
ized countries. Sixty percent to 90% of adults suffer or
have suffered from low back pain during their life in
industrialized countries,1–3
and the prevalence increase
constantly in these countries. Back complaints accounted
for 6.9%1
of consultations with physicians in cities.
Although nonspecific low back pain accounts for a
very large majority of low back pain, a distinction is
made between acute (less than 4 weeks progression),
subacute (between 4 weeks and 3 months), and chronic
low back pain (more than 3 months).2
Low back pain
evolution is frequently quickly favorable in few days,
with or without treatment, with a frequent risk of recur-
rence.4
Indeed, for Coste et al,5
50% of episode last less
than 1 week and 90% less than 2 weeks, but for von
Korff,6
“the course of back pain is highly variable, oc-
curring in transient, recurrent, and chronic phases.” The
evolution must be evaluated at long-term follow-up. For
von Korff and Saunders,7
after 1 year or more of an acute
episode, “33% report intermittent or persistent pain of
at least moderate intensity, 1 in 7 continue to report back
pain of severe intensity, and 1 in 5 report substantial
activity limitations.” More recently Enthoven et al8
re-
ported after a 5-year follow-up that 52% of subjects
have always pain and functional limitations. In these
conditions, low back pain has a considerable impact in
terms of medical costs (consultations, medical pre-
scriptions, . . .) and repercussion on occupational
activity.1,7–9
Many propositions of treatment, sometimes with
combination, are reported. In acute or subacute low
back pain, treatment tries to reduce or control the pain
intensity to enable fast resumption of occupational and
personal activities.
Lumbar orthosis (corsets or belts) are proposed as a
part of the wide range of therapeutic10–12
and preven-
tion13–15
options in practice. The antalgic effect is ex-
pected because of the control of lumbar mobility, the
relative immobilization of the lumbar spine, and some
subjective effects (heat, massage, continuous stimula-
tion).12,16
These effects are still the subject of debate.
Recent literature17,18
about the efficacy of lumbar belts
in low back pain reported that their use as a mean of
preventing low back pain is not proved and current
knowledge does not allow a judgment of their interest
in the treatment of low back pain. For van Tulder et al,
there is some scientific information, which emphasizes
From *Service de Médecine Physique et Réadaptation, Université Jean
Monnet, Hôpital Bellevue, Saint Etienne, France; †Centre Hospitalier
de Saint Etienne, Saint-Etienne, France; ‡Service de Médecine Physique
et Réadaptation, Hôtel-Dieu, Paris, France; §Aramis Consultants,
Neuilly sur Seine, France; and ¶Service de Rééducation Neuro-
Orthopédique Hôpital Rothschild APHP, Paris, France.
Acknowledgment date: January 4, 2008. First revision date: July 13,
2008. Second revision date: August 27, 2008. Acceptance date: August
27, 2008.
The manuscript submitted does not contain information about medical
device(s)/drug(s).
No funds were received in support of this work. No benefits in any
form have been or will be received from a commercial party related
directly or indirectly to the subject of this manuscript.
Address correspondence and reprint requests to Paul Calmels, PhD,
MD, Service de Médecine Physique et Réadaptation, CHU Saint-
Etienne, Hôpital Bellevue, 42055 Saint Etienne Cedex 2, France.
E-mail: paul.calmels@chu-st-etienne.fr
215

12. the therapeutic potential of lumbar belts for low back
pain.18
Nevertheless, few studies have been carried out
on the therapeutic efficacy of lumbar belts and, those that
have been carried out are now outdated, contain contra-
dictory results and/or are often not comparable. Further-
more, the methodologic weakness of most of these stud-
ies reported in the Cochrane review18
(low number of
subjects included, cointervention not documented . . .)
does not allow robust interpretation of their results.
More recently, in a review, van Tulder et al19
conclude
that there is limited evidence of efficiency of lumbar sup-
ports in comparison with no treatment and that they are
more effective than other interventions for treatment of
low back pain. Therefore, a controlled study is neces-
sary, with randomization of the patients, exclusion of
acute low back pain, and use of valid, reliable, and sen-
sitive instruments for measuring efficacy.
Objective
The objective of the study was to assess the effectiveness
of the lumbar belt in the treatment of patients suffering
from subacute low back pain. Efficacy criteria—2 clinical
effectiveness criteria and 1 economical criterion were de-
fined and evaluated over the whole follow-up period:
The functional recovery measured over 3 months us-
ing EIFEL scale (French version of the Roland-Morris
scale).
The change in pain intensity measured with a visual
analogical scale (VAS) of 100 mm assessed.
The medical consumption assessed by number of days
with analgesic, anti-inflammatory, and/or myorelax-
ant agents.
Materials and Methods
The trial was a multicentric, open, prospective, and random-
ized clinical study of a lumbar belt and “control group” (CG) in
the treatment of subacute low back pain with follow-up mon-
itoring lasting 3 months. This study was approved by Ethic
Committee (CCPPRB Rhoˆne Alpes–Loire N° 2004-13) and
had received Centre National Informatique et Liberte´ authori-
zation for data collection.
Population
The studied population was made up of patients suffering from
subacute low back pain treated by a family practitioner. Inclu-
sion and exclusion criteria are presented in Table 1.
The sample size had an estimated total of 210 patients. Two
groups are randomized (the “wearing belt group” (WBG) and
the CG with 105 patients in each group. The number of neces-
sary subjects was estimated to highlight a significant difference
in the level of score on the EIFEL scale between the 2 groups
analyzed. A difference of 2 points on the EIFEL scale of a
maximum score of 24 is considered to be clinically significant.
Under these hypotheses, with an alpha risk of 0.05 and a beta
risk of 0.1 (statistical power of 90%) the number of patients
required is 84 per group, or 168 patients in total. To take into
account patient compliance issues regarding wearing of the
lumbar belt, a 25% increase in the number of persons involved
was allowed.
Recruitment of the patients was proposed by the practitio-
ners to all subjects consulting for subacute low back pain and
had to stop after all the 210 patients had been recruited. For the
WBG the practitioners gave the belt (which was provided and
delivered to the practitioners) to the eligible randomized pa-
tients. The instructions were to wear it during the whole day
and over the whole duration of the trial and to explain how to
adjust it. A call center was set up to answer all the questions
asked by the patients regarding the belt. For the CG the patients
did not receive the belt. The practitioners asked them not to
purchase the belt or to wear a lumbar belt for the whole dura-
tion of the study. At the end of the 3 months of the study, if the
practitioner considered it to be necessary, prescription of a
belt could be suggested to the patient. For each group the
other treatments were left to the discretion of the investigat-
ing practitioner.
Randomized assignment was carried out initially with a
block of 6 patients for each practitioner. During the study, to
compensate for the insufficient number of patients recruited by
certain practitioners, the block was increased from 6 to 8, just
for them who had already included 6 patients and able to in-
clude 2 more. After the inclusion of each patient (satisfying the
eligibility criteria and consent form), the practitioner connected
with a vocal server (AREMIS Consultants) to find out which
group the patients were included.
Recruitment of the investigating practitioners was carried
out randomly from a database of practitioners developed by
CEGEDIM Company (Boulogne-Billancourt, France). On a list
of 757 practitioners solicited, 61 had accepted to participle and
44 were active for patient’s recruitment. Participation of the
investigating practitioners required that they accept the proto-
col, agree the remuneration, the quality control process, be
capable of fulfilling the recruitment.
Table 1. Inclusion and Exclusion Criteria
Inclusion criteria
Men or women between 20 and 60 yr of age
Treatment for an initial episode or recurring nonspecific low back pain
Episode lasting 1 to 3-mo
No contraindications to step I or step II analgesics, NSAID,
benzodiazepines and thiocolchicoside
Signing the consent form, which was explained to them first
Exclusion criteria
Patients who have used a lumbar belt during the last 6 mo
Patients who have low back pain irradiating beyond the knee and/or
accompanied by neurological signs, including sciatica,
Patients who have suffered from a low back pain episode during the 6
mo preceding inclusion
Patients who had had a spinal operation during the 5 yr preceding
inclusion
Patients who have secondary low back pain due to an accident at
work
Patients who have a history of spinal arthrodesis
Patients who have an unstabilized or symptomatic, chronic cardiac or
respiratory complaint
Patients who suffer from low back pain with an inflammatory, tumoural,
or infectious cause
Patients with a contraindication to step I or step II analgesics, NSAID,
benzodiazepines, and thiocolchicoside
Patients who are pregnant
Patients whose higher functions do not enable them to properly
comprehend the protocol or to reliably record the data
Exclusion of patients with a chronic cardiac or respiratory complaint
was justified by the theoretical warning of the potential effect of
wearing a lumbar belt on the increase in cardio-respiratory load
216 Spine • Volume 34 • Number 3 • 2009

13. Medical Device Experimented
It was an elastic textile lumbar belt Combitex with crossed
bands and posterior metallic reinforcement (Lomba-Cross Ac-
tivity, Thuasne, France). It is a class 1 medical device “CE
marked” in conformity with n° 93/42/CEE directive.
Outline of the Study
The total duration of the study was 24 months (09/2004-09/
2006), with an inclusion phase of 12 months. The patients were
examined 3 times, on D0 inclusion, on D30 Ϯ 3 days, on
D90 Ϯ 3 days, and an intermediate contact was realized at
D60 Ϯ 3 days (D60) by a phone survey. The collected infor-
mations during the follow-up were:
At inclusion (D0), questionnaire with: complete sociode-
mography data of the patient (age, sex, height, weight); general
clinical state and clinical conditions of the low back pain, his-
tory, and previous treatments; measurement of the EIFEL scale
and pain VAS; and current treatment and prescribed treatment.
At the visits (D30, D90) and phone survey (D60), question-
naire with: assessment of wearing the belt since the last visit
(patient compliance for WBG); measurement of the EIFEL
scale and pain VAS; and use of medical treatments since the last
visit (pharmaceutical intake) and just for the visits, treatments
prescribed. The data were collected at D0, D30, D60, and D90,
and the analysis was carried out in an anonymous way by
ARAMIS Consultants.
Instrument
The EIFEL scale is a valid and reliable self-questionnaire for
assessing functional capacity in low back pain.20,21
It consists
of 24 questions. The patient must answer each question in
function of the difficulty applicable on the day the question-
naire is completed. Each question equals 1 point and the total
EIFEL score corresponds to the sum. Thus, a score of 24 cor-
responds to the most unfavorable situation (total functional
incapacity associated with their low back pain). The pain VAS
was measured with a horizontal scale from 0 (no pain) to 100
(maximal pain).
Statistical Analysis
The statistical analyses had been carried out on: the intention to
treat population (ITTP) corresponds to all randomized patients
fulfilling the inclusion and noninclusion criteria without regard
they complied with the lumbar belt wearing recommendations
or not; the per protocol population (PPP) corresponds all the
patients in the ITT whose efficacy criteria (EIFEL and VAS)
were measured at D0 and D90 and who wore a lumbar belt at
least once a week during the whole duration of the follow-up
for the WBG and those who never wore a belt for CG.
A descriptive analysis of the population was carried out on
the 2 groups at D0 to compare them. The efficacy analyses were
carried out on the various treatment groups by means of a
variance analysis with recurring measurements for comparing
the main and secondary efficacy criteria (variations in the
EIFEL and VAS scores, days of analgesic intake). In addition, a
comparison was carried out on the rate of patients responding
(i.e., showing an improvement in EIFEL score of at least 2
points from 24).
The qualitative variables were presented with the persons
involved and frequency of representation for each modality.
The quantitative variables were presented with their average,
standard deviation, median, and extreme values. All the de-
scriptive analyses were carried out according to the randomiza-
tion group (WBG and CG) and for the whole population. For
each variable, a comparison test was carried out between the 2
groups studied, and was presented in the table of results: t test
for the quantitative variables; ␹2
for the qualitative variables.
The missing data (no answer) for the main clinical criteria
(EIFEL score and VAS score) was taken into account by apply-
ing the imputation method to the average data. For an individ-
ual, the missing data of a variable were replaced with the aver-
age of the calculated values based on the individuals in the same
subpopulation.
Analysis of the variance of the repeated data enables the
existing correlation between different measurements (over
time) for the same individual to be taken into account.
ANOVA, with repeated data were carried out using the
Figure 1. Population and number of persons in each group for each of the visits (D0, D30, and D90) or telephone contact (D60).
217Lumbar Belt in Subacute Low Back Pain • Calmels et al

14. MIXED procedure of SAS, with retention of the repeated
option for the individuals. The statistical analyses were car-
ried out using the SAS software V8.02 in the Windows en-
vironment.
Results
Population
Two hundred seven patients were randomized (106
WBG and 101 CG)(Fig. 1). After checking and validating
the data, 197 patients correspond to the ITTP, 102
WBG, and 95 CG (6 patients did not observe the inclu-
sion criteria and for 4 patients we never received the
inclusion questionnaires, 2 in WBG and 2 CG). The PPP
contained 171 persons (90 WBG and 81 CG) (Fig. 1).
The characteristics of ITTP were a ratio of 54.8% men,
an age average of 43 Ϯ 10.7 years, weight of 73 Ϯ 15.4
kg, and height of 170 Ϯ 8.7 cm. The PPP characteristics
were comparable.
There were no significant differences between the 2
groups regarding their socio-demographic characteris-
tics, way of life, physical activities and occupation,
health status at the beginning of the study, medical his-
tory on the spine, previous medical treatment for low
back pain, and characteristics of this low back pain epi-
sode (duration, responsible factors, . . .). There was also
no significant difference regarding the efficacy criteria at
the beginning of the study: EIFEL score: 10.3 Ϯ 4.3 WBG
and 10.1 Ϯ 4.3 CG; VAS score: 60.9 Ϯ 17.7 WBG, and
59.7 Ϯ 18.1 CG; drugs consummation: 66% of patients
don’t use medication at the inclusion, with 64.7% WBG
and 67.4% CG.
In WBG, the patients wore the belt, on average and
per week, 5 days at D30, 4 days at D60, and 3 days at
D90. In addition, the number of daily hours on which the
belt was worn was 8 hours at D30, 6 hours at D60, and
finally 5 hours at D90.
Change in EIFEL Score
There was a significant difference of change of EIFEL
score between WBC and CG: from D0 to D30, respec-
Figure 2. Change in EIFEL score
between D0 and D90.
Figure 3. Change in VAS score
between D0 and D90.
218 Spine • Volume 34 • Number 3 • 2009

15. tively, reduction in the average EIFEL score by 5.4 Ϯ 4.1
and 4.0 Ϯ 4.3 for CG (P ϭ 0.022); from D0 to D90
reduction by 7.6 Ϯ 4.4 and 6.1 Ϯ 4.73 (P ϭ 0.023) (Fig. 2).
Change in Pain Intensity
There was a significant difference of change of VAS pain
intensity between WBG and CG: from D0 to D30, re-
spectively, reduction in the average VAS score by 26.8 Ϯ
18.2 and 21.3 Ϯ 18.7 (P ϭ 0.038); from D0 to D90
reduction in the average VAS score by 41.5 Ϯ 21.49 and
32.0 Ϯ 20.0 (P ϭ 0.002) (Fig.3).
Medication Consumption
There was a significant difference of the medication con-
sumption between WBG and CG: at D90, the proportion
of patients who did not take any medication in WBG is
60.8% versus 40% in CG (P ϭ 0.029).
The proportion of patients who took at least 1 medi-
cation at the time of inclusion was identical for both
groups (33% WBG and 32.6% CG), increased during
the first month of follow-up (D30: 66.7% WBG and
78.9% CG; P ϭ 0.039), and fall after (D90: 34.3% WBG
and 56.8% CG; P ϭ 0.002), so that WBG consumed far
fewer medication treatments than CG.
Discussion
The results of this study show that wearing a lumbar belt
in the subacute low back pain is benefic for functional
recovery, pain intensity control, and medication con-
sumption.
At our knowledge there is no comparable study in low
back pain with a so large population, a CG, and a ran-
domization, with a multicentric participation, and tak-
ing into account antalgic, functional, and medication
consumption benefices during a so long-phase of treat-
ment. Some methodologic characteristics of this study
are in agreement with the recommendations of the just 3
studies can be considered for the effects reported on pain
intensity.
Penrose et al22
reported the results of wearing a pneu-
matic belt during 6 weeks in low back pain. This was a
randomized study with a CG but without any precision
about the low back pain history, the duration of the
episode, and the complementary treatment. The evalua-
tion was made on pain, muscle strength, and mobility of
the back. Each subject has been evaluated after 1 hour, 3,
and 6 weeks of wearing the belt. The results show a
significant decrease of pain intensity for BWG respec-
tively with 18%, 46%, and 73% at 1 hour, 3, and 6
weeks. The results were significantly less for the CG. It
was the same for muscle strength and mobility. The com-
pliance to the wearing of the belt was not evaluated.
Valle-Jones et al11
have analyzed the benefices of
wearing a back support in the treatment of acute non
specific low back pain, at 10 to 12 days. This random-
ized, controlled, parallel-group clinical trial was carried
out in general practice. Two hundred sixteen patients
have been included (111 wearing corset and 105 con-
trols). All the patients had also paracetamol from 1 to 4 g
a day if necessary to control pain. A self evaluation was
made daily during 3 weeks, with pain intensity level (at
rest, at night, and during activity), limitation activity
level, antalgic consumption, and ability to work. A clin-
ical examination of back mobility was realized at the
beginning and end of the period. After 21 days, all the
patients were ameliorated for pain intensity, limitation
activity level, but this amelioration was significant
greater for wearing group than CG. A significantly
higher proportion of patients in the wearing group could
work normally respectively 85% vs. 67% (P Ͻ 0.02) and
for the wearing group the analgesic consumption was
significantly lower (P Ͻ 0.0001). Clinical assessment
scores were significantly superior in the wearing group
(P Ͻ 0.002).
Calmels et al23
have conducted a randomized and
multicentric study with a CG on the effects of the wear-
ing of a tissue belt during 3 weeks after acute low back
pain. The results showed, after 8 days, a significant de-
crease of pain intensity evaluated by VAS for wearing
belt group (P ϭ 0.029) and of the mobility (outdistance
hand-ground) (P ϭ 0.05); after 21 days a significant in-
crease of functional capacities (0.028 Ͻ P Ͻ 0.032) and
medical consumption (P ϭ 0.028). For this study as this
of Valle-Jones et al, the limitations are a too small pop-
ulation and a too short period of assessment.
First, our study reports a clinical efficiency of lumbar
belt wearing for the subacute low back pain as a comple-
mentary treatment to medication. The use of belts, cor-
sets, or orthoses is frequently reported as an alternative
therapeutic associated in low back pain but without
strong evidence. The benefice can be explained by some
mechanical effects in regard with all the components of
low back pain: limitation of the back mobility,24,25
and
more specifically the limitation of the flexion in subjects
daily activities, which is reported as an important factor
of disc constraint26,27
and back pain intensity28
; increase
of intra-abdominal pressure,26,29
which is an other fac-
tor to decrease disc pressure,26
limit disc compression,
and disc pain; postural control with an educative effect
by belt to maintain spine in a relative extension as pro-
posed to prevent back problems30
; spine stability and
adaptation of muscle activity.29,31–33
In the case of belt,
the limitation of the mobility and pressure are less than
for rigid orthoses but the effect on postural control can
explain the clinical benefice reported by recent studies on
the benefices of belt wearing.34–37
The second important aspect and never analyzed in
this clinical situation is the global benefice on medical
consumption. This constitute an important argument,
because of the economic impact and the potentially de-
crease of iatrogenic effects of some antalgic or anti-
inflammatory drugs used to treat low back pain. If this
result is interesting, it must be discussed. There is a more
important and significant decrease of medication use for
WBG than CG at the end of the study, but in each group
it is also reported an increase in the first month; this was
due that, at inclusion, the practitioners can prescribe
219Lumbar Belt in Subacute Low Back Pain • Calmels et al

16. medication with belt to reduce pain intensity for this
patients who consulted for the first time for this back
pain episode. It is also reported no difference between the
number of medication use at the beginning and at the end
of the study for WBG; this must be considered in this
study as “wearing belt” decreases medication consump-
tion comparatively with “no wearing,” but does not sup-
presses all medications; wearing belt is a complementary
and not the primary treatment of back pain. In regards
with different treatments proposed for low back pain, it
is also interesting to underline that lumbar belt wearing
does not induce secondary or iatrogenic effects and that
there is no contraindication, which can induce some pref-
erences to a belt wearing than more aggressive therapy.
In conclusion, this study reports significant results of the
clinical and functional benefices to wearing a tissue belt as a
complementary treatment of subacute low back pain, with
a significant decrease of medication consumption.
Key Points
● It is a multicentric, randomized, and controlled
study of clinical evaluation of a lumbar belt in sub-
acute low back pain.
● The clinical criteria were the physical restoration
assessed with the EIFEL scale, the pain assessed by
a VAS, the economical criteria was the overall cost
of associated medical treatments.
● One hundred ninety-seven patients have partici-
pated. The results show a higher decrease in EIFEL
score, VAS score, and pharmacologic consumption
in wearing belt group than CG.
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in patients with non-specific low back pain. Curr Mel Res Opin 1992;12:
604–613.
12. Koes BW, van Den Hoogen HMM. Efficacy of bed rest and orthoses on low
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13. Barron A, Feuerstein M. Industrial back belts and low back pain: mecha-
nisms and outcomes. J Occup Rehabil 1994;4:125–39.
14. Minor SD. Use of back belts in occupational settings. Phys Ther 1996;76:
403–8.
15. Dillingham TR. Lumbar supports for prevention of low back pain in the
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16. van Poppel MN, de Looze MP, Koes BW, et al. Mechanisms of action of
lumbar supports: a systematic review. Spine 2000;25:2103–13.
17. Jellema P, van Tulder MW, van Poppel MN, et al. Lumbar supports for
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framework of the Cochrane Back Review Group. Spine 2001;26:377–86.
18. van Tulder MW, Jellema P, van Poppel MN, et al. Lumbar supports for
prevention and treatment of low-back pain (Cochrane Review). The Co-
chrane Library. Chichester, UK: John Wiley & Sons; 2004.
19. van Tulder MW, Jellema P, van Poppel MN, et al. Lumbar supports for
prevention and treatment of low-back pain. Cochrane Database Syst Rev
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20. Roland M, Morris R. A study of the natural history of back pain. Part I:
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lumbar support on muscular strength, flexibility and functional impairment
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tionnel du port d’une ceinture lombaire souple dans la lombalgie aigue¨. Ann
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24. Axelsson P, Johnsson R, Stro¨mqvist B. Effects of lumbar orthosis on inter-
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25. Giorcelli RJ, Hughes RE, Wassell JT, et al. The effect of wearing a back belt
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26. Nachemson A, Schultz A, Andersson G. Mechanical effectiveness studies of
lumbar spine orthoses. Scand J Rehabil Med 1983;9:139–49.
27. Adams MA, May S, Freeman BJ, et al. Effects of backward bending on
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28. Donelson R, Grant W, Kamps C, et al. Pain response to sagittal end-range
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Original Contribution | June 10, 1998
Mireille N. M. van Poppel, MSc; Bart W. Koes, PhD; Trudy van der Ploeg, MD; Tjabe Smid, PhD; Lex M. Bouter, PhD
ABSTRACT
Context.— Low back pain is a frequent and costly health problem. Prevention of low back pain is important both for the individual patient and from an economic perspective.
Objective.— To assess the efficacy of lumbar supports and education in the prevention of low back pain in industry.
Design.— A randomized controlled trial with a factorial design.
Setting.— The cargo department of an airline company in the Netherlands.
Participants.— A total of 312 workers were randomized, of whom 282 were available for the 6-month follow-up.
Interventions.— Subjects were randomly assigned to 4 groups: (1) education (lifting instructions) and lumbar support, (2) education, (3) lumbar support, and (4) no
intervention. Education consisted of 3 group sessions on lifting techniques with a total duration of 5 hours. Lumbar supports were recommended to be used during working
hours for 6 months.
Main Outcome Measures.— Low back pain incidence and sick leave because of back pain during the 6-month intervention period.
Results.— Compliance with wearing the lumbar support at least half the time was 43%. In the 282 subjects for whom data were available, no statistically significant differences
in back pain incidence (48 [36%] of 134 with lumbar support vs 51 [34%] of 148 without, P=.81) or in sick leave because of low back pain (mean, 0.4 days per month with
lumbar support vs 0.4 days without, P=.52) were found among the intervention groups. In a subgroup of subjects with low back pain at baseline, lumbar supports reduced the
number of days with low back pain per month (median, 1.2 vs 6.5 days per month; P=.03).
Conclusions.— Overall, lumbar supports or education did not lead to a reduction in low back pain incidence or sick leave. The results of the subgroup analysis need to be
confirmed by future research. Based on our results, the use of education or lumbar supports cannot be recommended in the prevention of low back pain in industry.
LOW BACK PAIN occurs frequently and is one of the most costly health problems affecting industry and society. Lifetime prevalences of 60% to 90% have been reported1 and
the total (direct and indirect) costs for back pain were estimated to be $27.9 billion in 1990 in the United States.2 Therefore, it is not surprising that many measures are available
that claim to reduce low back pain and its recurrence. Aside from ergonomic adjustments in the workplace, the most commonly used preventive strategies in industry are fitness
exercises, education on back mechanics and lifting techniques, and lumbar supports.3 Although these measures are widely used, their efficacy is still uncertain.
In particular, the efficacy of lumbar supports is under debate. To date, at least 3 randomized trials are available that evaluate the effect of lumbar supports on the prevention of
back pain in industry. In 2 of these, no effect of lumbar supports was reported.4- 5 The third study found a small reduction in the number of days lost from work in a group
receiving both a lumbar support and education compared with a control group.6 In addition, 2 nonrandomized controlled trials reported a positive effect of lumbar supports in
the reduction of back pain incidence.7- 8 Review articles concluded there is insufficient evidence for or against the effectiveness of lumbar supports in the prevention of low
back pain and that further research is needed.3,9- 11 The same conclusion was reached in a report of the US National Institute for Occupational Safety and Health (NIOSH) and,
consequently, the use of lumbar supports among uninjured workers was not recommended by NIOSH.12
We conducted a randomized controlled trial to determine the effectiveness of lumbar supports and education in the prevention of back pain in industry conducted in the
Netherlands.
METHODS
A factorial randomized design was used: group 1 received both a lumbar support and education in the form of lifting instructions, group 2 received only education, group 3
received only a lumbar support, and group 4 received no intervention (control group). In a factorial design, in addition to assessing the effect of interventions by comparing them
with a control group, the combination of 2 interventions is compared with each intervention alone and with a control group, thus allowing investigation of the interaction
between the 2 interventions.
Workers were recruited from the cargo department of a major Dutch airline at Schiphol Airport. All workers whose jobs included manual material handling were invited to
participate. Typical tasks of these workers included the loading and unloading of cargo pallets and containers and the sorting and transportation of cargo, both manually and with
a forklift truck. Workers who had a permanent partial work disability were excluded from the study. The study was approved by the Medical Ethical Committee of the Vrije
Universiteit, Amsterdam, the Netherlands. Workers received personal information about the procedures of the trial and enrolled after giving consent. The duration of the
intervention period was 6 months.
The Work S'port back support (The Saunders Group Inc, Chaska, Minn) was chosen over 2 other lumbar supports in a pilot study. In the pilot study the comfort of the different
supports was tested in a group of 20 workers who were not included in the randomized trial. The lumbar support used in the study has adjustable elastic side pulls with Velcro
fasteners and flexible stays, and is kept in place with an anchor belt. The lumbar support has no shoulder straps and is available in 4 sizes. The workers were given written and
verbal instructions on the use of the lumbar support and were instructed to wear the lumbar support at all times during work hours and to tighten the side pulls for stronger
support when performing strenuous tasks.
Education was given in the form of lifting instructions. The lifting instructions were given by 2 experienced paramedical therapists. Instructions were designed to make workers
aware of their movements and postures during work. Lifting instructions were given in 3 sessions for groups of 10 to 15 workers; the first session of 2 hours took place at the
start of the intervention period, and the other 2 sessions of 1.5 hours each were given at 6 weeks and at 12 weeks. In the first session, information was given about the anatomy
of the spine and back muscles and about lifting techniques. Lifting techniques were practiced in simple situations. In the second session, the instructions on lifting techniques
were repeated, and relaxation exercises for neck, shoulder, and back muscles were explained and practiced. In the third session, which took place at the workplace when workers
were actually loading and unloading cargo, individual advice was given on working methods.
The work at the cargo department was organized in work modules (n=6), with each work module consisting of 6 work groups containing 6 to 20 workers each. Workers in all
work modules performed manual lifting tasks and used a forklift truck. The work modules differed slightly in the proportion of time spent using a forklift truck and performing
lifting tasks. A total of 380 workers in 36 work groups were eligible for the study. We assumed that compliance would be higher if all workers in a group, rather than a subset of

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the group, were asked to wear a lumbar support. Furthermore, it was practical to use the existing work-group organization for the education sessions. Therefore, the 36 work
groups, not individual subjects, were randomized over the 4 treatment groups. Because of the slight variation in tasks among some work modules, randomization was stratified
for work modules.13 For each work module, a separate randomization list was prepared. Random permuted blocks of 4 were used within each stratum. The blocks were assigned
to the strata using a random numbers table.
Randomization was performed by an investigator who was blinded with respect to the characteristics of the work modules and the workers within the work groups. Assignment
to the intervention groups took place after completion of the baseline measurements.
At baseline subjects completed a questionnaire on demographic data, history of back pain, work perception,14 and health status.15- 16 During the intervention period, subjects
received a monthly questionnaire on the occurrence of low back pain and sick leave. Subjects were asked if they had experienced low back pain in the past month and, if they
answered positively, how many days they experienced low back pain. They were also asked if they had lost time from work in the past month (and the number of days lost) and
if they had lost time from work because of back pain (and the number of days lost). All subjects worked full time. The same questionnaire on back pain and sick leave was
completed at 9 months and 12 months after randomization.
At baseline and at 6 months, the end of the intervention period, trunk-muscle strength was measured to assess whether wearing a lumbar support affected trunk muscle strength.
Subjects with current or past back pain who felt they might injure or reinjure their backs by performing the tests were excluded from the trunk-muscle tests. The endurance
strength of the abdominal muscles was determined with subjects lying supine with knees at 90° and feet flat on the floor or table without support.17 Subjects were asked to curl
up with hands straight toward knees and fingertips of both hands reaching midpatella. This posture was held for a maximum of 240 seconds. If the posture was lost, the test was
stopped and the number of seconds was noted. The dynamic strength of the abdominal muscles was measured with subjects lying supine with knees at 90° and feet flat on the
floor without support.18 Subjects were asked to perform 3 series of 5 sit-ups with increasing difficulty. The number of sit-ups performed by each subject was noted. Endurance
strength of the back muscles was determined with subjects prone on the examination table with buttocks and legs fixed and trunk unsupported.19 Subjects were asked to hold
their upper body and head horizontal for a maximum of 240 seconds. If the posture was lost and could not be corrected, or if a subject showed signs of exhaustion, pain, or
cramping, the test was stopped and the number of seconds was noted.
Compliance with wearing the lumbar support was measured every month. In the monthly questionnaire subjects were asked if they had worn the lumbar support in the previous
month. Subjects were considered compliant if they reported wearing the lumbar support in more than half of the questionnaires.
Based on the difference in days lost from work and corresponding variance reported by Walsh and Schwartz,6 it was estimated that with a significance level of .05 and a power
of 80%, a difference of 0.9 lost work day per 6 months could be detected with 50 subjects per intervention group. Our goal was to include 75 subjects per intervention group in
order to prevent inadequate power because of low compliance or withdrawals.
Differences in outcomes at the 6-month follow-up were analyzed for the 4 intervention groups. Differences between groups were tested for statistical significance by using χ2
tests for categorical data (ie, experience of back pain and sick leave) and Student t tests for continuous data (ie, age, scores on trunk muscle tests). Nonparametric testing (the
Mann-Whitney U test or the Kruskal-Wallis test, corrected for ties) was used for data on the number of days with back pain or sick leave, since the distribution of these data is
skewed. Differences were considered statistically significant at the .05 level. For categorical data, differences between groups and 95% confidence intervals (CIs) were
calculated.20
Possible effect modification in the group with both lumbar support and education was studied in an analysis in which the 2 groups with a single intervention were combined and
compared with the group that received both interventions. The control group was removed from this analysis. If effect modification were present, the groups would differ
significantly. If no effect modification were present in the group with the combination of lumbar support and lifting instructions, groups would be combined as follows to
increase the number of subjects in the compared groups. The 2 groups with lumbar supports would be compared with the 2 groups without lumbar supports, and a similar
comparison would be made for education.
For the effect of lumbar supports, 2 types of analyses were performed: an analysis of the intervention group in which all subjects for whom data were available were included,
regardless of compliance with wearing the lumbar support; and 2 subgroup analyses assessing only subjects who were compliant with lumbar support use and whether subjects
had a history of low back pain at baseline.
RESULTS
Of 380 eligible workers, 20 (5%) refused to participate and 312 (82%) completed the baseline measurements (Figure 1). Because of holidays and a large workload, workers were
not always available for the study. Consequently, baseline measurements were missing for 48 workers. During the intervention period of 6 months, 30 workers (10%) withdrew
from the study. Twenty-one workers (7%) withdrew because they lost interest in the study after the baseline measurement (mostly because workers did not think that the study
was useful to them). Nine workers (3%) transferred to another workplace or left the company. Another 14 workers (4%) transferred to other workplaces in the second 6 months
of the follow-up period. Only 1 of the 23 workers who transferred to another workplace left the cargo department because of low back pain. The distribution of the withdrawals
among the intervention groups is shown in Figure 1. A description of the study population is given in Table 1. There were no substantial differences among the 4 intervention
groups regarding the most important prognostic factors, such as age, history of back pain, and past sick leave because of back pain. Work modules were evenly distributed
among the intervention groups; for all modules, about half of the workers were given education and half received a lumbar support.

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At baseline, 243 subjects were asked about their expectations of preventive measures. Of these, 146 (60%) expected that lumbar supports could be helpful in the reduction of
low back pain in the workplace, and 170 (69%) felt lifting instructions could be useful. The attendance rate for the first educational session was 80%, and all workers attended at
least 2 of the 3 sessions. Subjects were asked each month if, in their own opinion, they lifted according to the techniques taught in the educational sessions. Of 142 subjects, 16
(11%) answered that they always lifted as taught, 104 (73%) answered that they lifted as taught some of the time, and 15 (11%) answered that they never lifted as taught.
Compliance with wearing the lumbar support was low; only 58 (43%) of the 134 subjects in the lumbar support groups reported wearing the support in more than half of the
questionnaires. In random checks by the principal investigator at the workplace, compliance was approximately the same as the subjects reported (40%-50%). When subjects
were asked how satisfied they were with the lumbar support, 39 (49%) of 79 subjects reported the support restricted their freedom of movement, 39 (48%) of 81 reported they
could not sit comfortably with the support, and 36 (45%) of 80 thought the support was too warm. On the other hand, 49 (62%) of 79 thought the support provided support for
the back and 37 (46%) of 80 reported the support was easy to use.
No data were available for 30 subjects (Figure 1, subjects withdrawn during intervention). Of the remaining 282 subjects, 99 (35%) experienced an episode of low back pain
during the intervention period and 29 (10%) reported having taken sick leave because of low back pain (Table 2). No statistically significant differences were found among the 4
intervention groups. No effect modification could be detected when comparing the group with lumbar support and education with the other 2 intervention groups combined.
Therefore, the groups receiving lumbar supports were combined, as were those receiving education. Table 2 shows the main outcomes for the groups. No statistically significant
differences were present. Low back pain incidence was about 35% in all groups, and subjects reporting sick leave due to low back pain varied from 8% to 13%.

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A subgroup analysis was conducted in which subjects who wore the lumbar support were compared with subjects in the groups without lumbar support. No significant
differences were observed (Table 3).

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Table 4 shows the results of the analysis of subgroups based on the history of back pain. In the subgroup of subjects who had never had low back pain (n=130), a higher number
of days of sick leave because of low back pain was observed in the group with lumbar support (P=.05), although the median number of days of sick leave per month was 0 days
in both groups. In the subgroup of subjects with low back pain at baseline (n=42), a reduction in the number of days with low back pain per month was found in the group with
lumbar support compared with the group without lumbar support (median of 1.2 days per month vs 6.5 days per month; P=.03). No significant differences were found between
groups with and without education in the subgroup analysis (data not shown).

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To detect possible adverse effects of lumbar supports, we measured trunk-muscle strength before and after the intervention period. Furthermore, after the intervention period,
subjects were followed up for an additional 6 months to evaluate the occurrence of low back pain after subjects discontinued wearing the lumbar supports. In the group
compliant with lumbar support use during the intervention period, 25% of the subjects reported low back pain during the 6 months following completion of the intervention vs
20% in the group without lumbar support (risk difference=5%; 95% CI, −13% to 23%; P=.6). Compliant subjects had a mean of 1.8 days of back pain vs 1.1 days in the group
that did not receive the lumbar support (median of 0 days in both groups; P=.5 by Mann-Whitney U test corrected for ties). Results of the trunk-muscle strength tests are shown
in Table 5. Thirty-eight subjects felt they would injure or reinjure themselves by performing the trunk-muscle tests and were excluded from the tests (10 in the combination
group, 5 in the education only group, 12 in the lumbar support only group, and 11 in the control group). Most subjects scored lower in the posttest, but the difference between
compliant subjects and subjects without lumbar support was not significant.

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COMMENT
No effect of education alone in the prevention of low back pain could be demonstrated in this study. This result confirms previous controlled trials,4,6,21- 24 all of which found
no effect of providing lifting instructions or instructions on body mechanics. The only controlled study that reported a positive effect of education was a study in a population of
bus drivers who received no lifting instructions but received a back school program consisting of information on back care, physical fitness, nutrition, relaxation, and coping
with stress.25
Lumbar supports were not effective in the prevention of low back pain and sick leave in this study. Two other randomized studies have reported the same findings.4- 5 Some
nonrandomized studies reported positive findings,7- 8,13 but these studies are more susceptible to various forms of bias. A recently published study by Kraus et al26 that included
36000 subjects reported a reduction in acute low back injury rate. However, because of the nonrandomized, noncontrolled design of the trial, the findings may be explained by
confounding factors, such as changes in exposure or workers' compensation laws.
In our study, the combination of lumbar support and education also was not effective. Two other studies that combined these interventions showed conflicting results. Walsh and
Schwartz6 reported a reduction in the number of days with sick leave, while Reddell et al4 found no effect. The cause of the contradictory results is unknown, but factors such as
work characteristics, differences in lumbar support (the study by Walsh and Schwartz6 used a rigid plastic support), and compliance rates could be important.
The study by Reddell et al4 had a compliance rate nearly identical to our study (42% and 43%, respectively). The only other study reporting compliance rate is the study by
Anderson et al,7 in which the compliance was 80% according to the supervisors at the workplace. Although our analysis of only subjects who were compliant failed to show a
positive effect of lumbar supports, it is possible that because of self-selection of compliant subjects, an effect of lumbar supports may have been missed. However, in the
Netherlands an employer would be unlikely to require use of lumbar supports or impose sanctions in the case of noncompliance. Therefore, the results presented here represent
what can be expected if an employer provides but does not require lumbar supports for manual material–handling workers.
Subgroup analysis is difficult because it is potentially misleading, even if the analysis is prospectively planned.27- 28 Yusuf et al27 state that they "regard observed qualitative
interactions (treatment is beneficial in one subgroup and harmful in another) with considerable skepticism, for they are often shown to be spurious when the same comparison is
made in similar trials." Yusef et al27 recommend that results from subgroup analyses should not be accepted until they are confirmed by the results of other studies.
The present study demonstrates a qualitative interaction. On one hand, the use of a lumbar support seemed to increase sick leave due to low back pain in subjects who had never
had low back pain before the start of the intervention (n=130). On the other hand, in a small group of subjects who had low back pain at the start of the intervention (n=42), the
use of lumbar supports reduced the number of days per month with low back pain.
Among workers without a history of low back pain, the differences between groups were small (0.6 vs 0.2 mean days per month of sick leave) and perhaps not clinically
relevant, and because we did not correct for multiple comparisons, differences may be due to chance. Therefore, we draw no conclusions from this analysis but believe studies
should investigate the effect of lumbar supports for this subgroup in more detail.
Walsh and Schwartz6 reported a larger effect of the combination of lumbar supports and education in a subgroup of workers who had low back pain in the 6 months prior to the
study, while we found no effects in a group of subjects who had low back pain in the year prior to the study (n=69).
A review on the effectiveness of orthoses in the treatment of back pain concluded that the therapeutic effect of lumbar supports for subjects with back pain has not yet been
demonstrated, although some promising findings were reported in the literature.29 This is consistent with our finding of a positive effect of lumbar supports in the subgroup of

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workers with low back pain at baseline. Nevertheless, future randomized trials on the effects of lumbar supports for patients with low back pain are needed to determine their
therapeutic value, if any.
No effects of lumbar supports on trunk-muscle strength were observed. Other studies also reported no adverse effects of lumbar supports on abdominal and back-muscle
strength.6,30 These results indicate the use of lumbar supports will not cause atrophy of trunk muscles.
Reddell et al4 reported an increase in incidence of sick leave because of back injury in groups of workers who stopped wearing a lumbar support during the intervention period.
We could not reproduce these findings, as no increase in the incidence of back pain was found after compliant workers discontinued wearing lumbar supports.
The major limitation of this study is the lack of blinding; neither the subjects nor the therapists who conducted the educational sessions were blinded for the intervention. The
direction and magnitude of the potential bias is not clear. It could lead to a larger estimate of the effect of the intervention,31 or perhaps to a smaller estimate, depending on the
expectations of subjects and investigators. However, at baseline most workers believed both interventions would be beneficial, so any potential bias from expectations would be
in the positive direction.
The subjects in our study all had very similar work tasks of loading and unloading cargo, including heavy-lifting tasks. Extrapolation of the results is most relevant for situations
in which workers perform similar lifting tasks.
Based on the results of our study, we do not recommend education (in the form as investigated in our study) or the use of lumbar supports in the prevention of low back pain.
The therapeutic effectiveness of lumbar supports for workers with low back pain in industry needs further investigation.
REFERENCES
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1991:107-146.
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3 Lahad A, Malter AD, Berg AO, Deyo RA. The effectiveness of four interventions for the prevention of low back pain. JAMA.1994;272:1286-1291.
4 Reddell CR, Congleton JJ, Huchingson RD, Montgomery JF. An evaluation of a weightlifting belt and back injury prevention training class for airline
baggage handlers. Appl Ergonomics.1992;23:319-329.
5 Alexander A, Woolley SM, Bisesi M, Schaub E. The effectiveness of back belts on occupational back injuries and worker perception. Professional
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6 Walsh NE, Schwartz RK. The influence of prophylactic orthoses on abdominal strength and low back injury in the workplace. Am J Phys Med
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7 Anderson CK, Morris TL, Vechio DC. The Effectiveness of Using a Lumbar Support Belt. Dallas, Tex: Advanced Ergonomics Inc; 1993.
8 Thompson L, Pati AB, Davidson H, Hirsh D. Attitudes and back belts in the workplace. Work.1994;4:22-27.
9 Barron BA, Feuerstein M. Industrial back belts and low back pain: mechanisms and outcomes. J Occup Rehabil.1994;4:125-139.
10 Genaidy AM, Simmons RJ, Christensen DM. Can back supports relieve the load on the lumbar spine for employees engaged in industrial
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11 van Poppel MNM, Koes BW, Smid T, Bouter LM. A systematic review of controlled clinical trials on the prevention of back pain in industry. Occup
Environ Med.1997;54:841-847.
12 National Institute for Occupational Safety and Health Back Belt Working Group. Workplace Use of Back Belts: Review and Recommendations.
Washington, DC: US Dept of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention; 1994. DHHS (NIOSH)
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17 Hyytiäinen K, Salminen JJ, Suvitie T, Wickström G, Pentti J. Reproducibility of nine tests to measure spinal mobility and trunk muscle strength. Scand
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32. Summaries for Patients
Back Supports to Prevent Back Pain in
Home Care Workers with Previous Low
Back Pain
Summaries for Patients are a service provided by Annals to help patients better
understand the complicated and often mystifying language of modern medicine.
Summaries for Patients are presented for informational purposes only. These
summaries are not a substitute for advice from your own medical provider. If you
have questions about this material, or need medical advice about your own health
or situation, please contact your physician. The summaries may be reproduced for
not-for-profit educational purposes only. Any other uses must be approved by the
American College of Physicians.
What is the problem and what is known about it so far?
Low back pain is a common problem that causes pain and inability to participate in
usual activities. It is a common reason for people to be absent from work,
especially among workers whose jobs involve physical labor. Treatment for low
back pain aims to decrease pain and help patients resume their normal activities
through exercise therapy, patient education, and pain-relieving drugs.
Patients also sometimes use “back belts” or “back supports” (lumbar supports) to
prevent or treat back pain. These supports come in a variety of styles, but all
involve a wide belt worn around the back and abdomen to support the muscles of
the lower back. People whose work involves physical labor or lifting often use back
supports. Unfortunately, good information about the benefit of back supports is
scarce. The available studies suggest that back supports do not prevent a first
episode of back pain, but they may help to prevent repeated episodes among
workers with previous back pain.
Why did the researchers do this particular study?
To see whether adding back supports to a course on healthy work habits would
help to decrease the number of low back pain episodes and days absent from work
among home care workers who had previous low back pain.
Who was studied?
360 home care workers in the Netherlands who reported a history of low back
pain. The workers' jobs involved housekeeping or help with personal care in
people's homes.
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33. How was the study done?
All of the workers participated in a short course on healthy work habits that
included information on strategies to prevent back injury, such as good ways to lift
heavy things. The researchers then assigned half of the patients to select and
receive 1 of 4 types of back support. The workers who got back supports were
advised to wear them on days when they had or thought they might get low back
pain.
What did the researchers find?
Over 12 months, the workers with the back supports reported an average of 53
fewer days with low back pain than those reported by the other workers. However,
days missed from work because of sickness were similar in both groups of
workers.
What were the limitations of the study?
The researchers did not have good information on whether back pain was the
reason for the sick days.
What are the implications of the study?
Adding back supports to a short course on healthy work habits may reduce low
back pain days, but not the total number of sick days, among workers.
Article and Author Information
The summary below is from the full report titled “Lumbar Supports to Prevent
Recurrent Low Back Pain among Home Care Workers. A Randomized Trial.” It is
in the 20 November 2007 issue of Annals of Internal Medicine (volume 147,
pages 685-692). The authors are P.D.D.M. Roelofs, S.M.A. Bierma-Zeinstra,
M.N.M. van Poppel, P. Jellema, S.P. Willemsen, M.W. van Tulder, W. van
Mechelen, and B.W. Koes.
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