Details are given for a range of clinical research projects investigating the use of dextrose injections for various orthopedic conditions, from finger and knee osteoarthritis to ACL laxity and TMJ disorders. The document reviews study locations, investigators, statuses,

1. Introducing
Research Into Your
Orthopedic
Medicine Practice
AAOM 29th Annual Conference April 18-21 2012
K. Dean Reeves, M.D.
Clinical Associate Professor
University of Kansas

2. I. KEY STAGES OF
RESEARCH

3. From Preliminary Idea to Literature Review
•Common
•Function Impairing
•Clear Rx Advantages
•Fast result
•Powerful Result
•Literature review
•Purpose Statement

4. Pre-Site Choice: Practical Considerations
•Preliminary Team
•Outcome Measures
•Power Analysis
•Precise Hypothesis
•Cost Estimates
•Site Choices

5. HSC Application and On-Line
Announcement
•Choose HSC
•Protocol
•Consent
•Privacy Form
•Phone Screening
•Advertising
•Send Application
•HSC Approval
•Clinicaltrials.org

6. From Enrollment To Publication
•Enroll 6-24 Mo
•Follow 1-2 Yr
•Submit/hear back 3 Mo
•Resubmit/hear back 3 mo
•Correct Proof 1 mo
•Publication 3 mo

7. From Preliminary Idea to Literature Review
O T K T T C C H H
● = Completed
S T N M M A A A A
N = Not applicable D P C J J U U N N
R A D D D D
P R
R B R H B H R R G
O O O K A I O O U
Common ● ● ● ● ● ● ● ● ●
Function Impairing ● N ● ● ● ● ● ● ●
Clear Rx ● ● ● ● ● ● ● ● ●
Advantages
Fast ● ● ● ● ● ● ● ● ●
Powerful ● ● ● ● ● ● ● ● ●
Purpose Statement ● ● ● ● ● ● ● ● ●
Literature Review ● ● ● ● ● ● ● ● ●

8. Pre-Site Choice: Practical Considerations
O T K T T C C H H
● = Completed
S T N M M A A A A
N = Not applicable D P C J J U U N N
R A D D D D
P R
R B R H B H R R G
O O O K A I O O U
Preliminary Team ● ● ● ● ● ● ● ● ●
Outcome Measures ● ● ● ● ● ● ●
Power Analysis ● ● ● ● ● ● ● ● ●
Precise Hypotheses ● ● ● ● ● ● ●
Cost Estimates ● ● ● ● ● ● ●
Site Choice(s) ● ● ● ● ● ● ●

9. HSC Application and On-Line Announcement
O T K T T C C H H
● = Completed
S T N M M A A A A
N = Not applicable D P C J J U U N N
R A D D D D
P R
R B R H B H R R G
O O O K A I O O U
Choose HSC ● ● ● ● ● ● ●
Protocol ● ● ● ● ● ● ●
Consent ● ● ● ● ● ● ●
Privacy Form ● ● ● ● ● ● ●
Phone Screen ● ● ● ● ● ● ●
Advertising ● ● ● ● ● ● ●
Send Application ● ● ●
HSC Approval ● ●
Clinicaltrials.org ● ●

10. From Enrollment to Publication
O T K T T C C H H
Time To Publication
S T N M M A A A A
From Enrollment D P C J J U U N N
27 mo – 57 mo R A D D D D
P R
R B R H B H R R G
O O O K A I O O U
Enroll 6-24 mo ●
Follow 1-2 yr ●
Submit 2 mo ●
Resubmit 2 mo ●
Resubmit 2 mo ●
Correct Proof 1 mo ●
Publication 2 mo ●

11. II. RESEARCH IN
PROCESS:
OPPORTUNITIES

12. Post Exercise RCT Dextrose
Cream
• Location: Vancouver
• Primary Investigatory: Helene
Bertrand
• Status: Preparing for May 6, 2012
(Vancouver Marathon)

13. Dextrose vs Vehicle Cream for Post Marathon Pain
Leg pain > 5/10 Post Marathon
Willing to apply cream three times daily? If yes, Randomize.
Treat both sides if opposite side has pain. Gather data on each leg
that has pain > 5/10.
20 20
Dextrose + Vehicle Cream Vehicle Cream Only for 5 days
BID-TID for 5 days
E mail Data collection of AM NRS daily X 5 days.
At end of 5 days a 7 point Likert Scale response will be requested
to the questions “I plan to use a cream like this in the future?”
1 month recheck for any potential side effects.
Comfortable running distance at 1 month

14. Arthroscopic Study Cartilage
Growth
• Location: Rosario
• Primary Investigator: Gaston
Topol
• Status: 1st group of 6 with 12.5%
dextrose completed. 2nd group of 6
underway with 25% dextrose.

15. Knee OA: Double Arthroscopy Protocol
Arthroscopy #1  Then wait until return
to baseline symptoms
Injection of 12.5% dextrose @ 0, 1, 2, 3,
4, and 5 month. (25% for 2nd group) (9
ml with HRUS guidance)
Use medial lift in 2nd group)
Arthroscopy #2 at 6 Mo
Follow for 1 Year with Injection
every 2-3 Months if symptomatic

16. Data Gathering
1st 0 6 Mo
Arth Mo
WOMAC X X
Walking Pain X X
Walking Distance X X
Extension Lack X X
Total flexion X X
Arthroscopic Video Pre/post MB X X
Biopsy of growth area for cartilage X
quality.

17. Histological Investigations
• Methylene Blue: Shows cartilage buds.
• Hematoxin and Eosin Staining: Column orientation
(organized cartilage) vs sporadic clumped (degenerative
cartilage)
• Saff O: Mucopolysaccharide (MPS) activity measure.
Pale in OA (dying cartilage). Red with regeneration .
• Polarized light: Fibrocartilage shows fibers
distinctly. Hyaline cartilage shows glassy
appearance. (No fibers)
• Collagen typing: type 1 in fibrous tissue; type II in
both fibrous and hyaline cartilage. Not essential but
orthopedic community will enquire.
• Mechanical properties: Not possible on small biopsy
and not expected.

18. Finger OA RCT: Dextrose
Cream
• Location: Guadalajara, Buenos
Aires
• Potential Primary Investigators:
David de la Mora, Irene Briseno,
Gonzalo Yamauchi.
• Status: Cream approval issues
blocking HSC approval in 1 site.
Pre-HSC submission in 2nd.

19. Finger OA: Dextrose vs Xanthan Gum
3 months of bilateral finger pain (Minimum 6/10) +
At least one painful joint on fingers 2-5 +
No finger “sticking”/No Painful flexor nodule +
No worse pain in other areas +
Inflammatory arthritis lab testing negative
15 Nighttime with gloves 15
Dextrose + Vehicle Cream Xanthan Gum + Vehicle Cream
3 Mo Data (Grip Pain + AUSCAN)
Dextrose + Vehicle Cream
12 Mo Data (Grip Pain + AUSCAN)
24 Month Data? (Repeat X-Ray, Grip Pain, AUSCAN

20. Epidural Dextrose Study
• Location: Hilo Hawaii, Rosario
Argentina
• Primary Investigators: Liza
Smigel, Gaston Topol (Resident)
• Status: Underway Hilo. Pre HSC
Rosario

21. Randomized Comparison of Immediate
Analgesic Effects of 5% Dextrose in
Water vs Normal Saline and 1 Year
Outcome Data of 5% Dextrose
administration.

22. NRS Pain + ODI 2.0 at 0 Months
#15 #15
10 ml D5W Caudal 10 ml NS Caudal
NRS Pain 15 min, 2 hrs, 4 hrs, 48 hrs  Unblinded@ 48 hrs,
Then 10 ml D5W if Not Received
90% or more reduction in Pain 15 minutes after Caudal D5W
Y N
D5W @ 2, 4, and 6 weeks and PRN. Offer
Continued 90% Reduction in Pain 15 N
Other
Minutes Post Injection? Rx
Y
NRS Pain + ODI 2.0 at 3 and 12 Months

23. Dextrose TMJ Study
• Location: Buenos Aires, Hong
Kong
• Primary Investigator: Miguel
Zarate, Ricardo Frusso, Stanley
Lam.
• Status: Near HSC approval. Delay
prior to HSC submission. Pilot
completed

24. RCT of Dextrose vs Lidocaine Injection for TMD
Facial Pain > 5/10 + Jaw symptoms > 5/10
+ Exam for Obvious Dental Issues?
Symptoms referable to jaw after exam? If Yes, Randomize.
Treat both sides if opposite side has pain or jaw dysfunction, but
gather data on the worst side
5 5
Dex 20%/Lido .2% 1ml Water/Lido .2% 1 ml
@ 0, 1, and 2 mo @ 0, 1, and 2 mo.
PRN Injection
6 Month Data Collection
PRN Injection
1 Year Data

25. Pilot Results: NRS Scale Changes
0 to 6 Months For
Dextrose (D) vs Lidocaine (L)

26. P Values for 10 Subject Study:
0 to 6 Months
• Multivariate analysis Dextrose Vs Lidocaine: Dextrose
better (p = .049)
• Univariate analysis Dextrose vs Lidocaine
Dextrose better in pain improvement (p = .013
Dextrose better in function improvement (p = .020)

27. Manual PRP Production
• Location: Beaver, Oregon
• Primary Investigator: Noel
Peterson, N.D.
• Status: Underway

28. PRP: Efficacy of Novice Teaching
25 tubes (196 ml total blood draw) FROM each novice preparer
12 Tubes for AM 12 Tubes for PM 1 tube for
“Close Supervision” “Intermittent Input” baseline
trials trials testing
6 Tubes 6 Tubes
Trial 1 Trial 1 0.75 0.75 0.75 0.75
ml ml ml ml
from from from from
3 3 3 3
tubes tubes tubes tubes
0.75 0.75 0.75 0.75
ml ml ml ml
from from from from
3 3 3 3
tubes tubes tubes tubes

29. Cytokine Synovial Fluid Study
• Location: Richmond, VA
• Primary Investigator: Potential Jeff
Ericksen/Jason Tucker
• Status: Pending Funding.

30. Facial/Trigeminal Neuralgia
• Location: Potential Ferrara, Italy
• Potential Primary Investigator:
Steven Cavallino
• Status: Design phase pre HSC
submission.

31. ACL Laxity Study
• Location: Open
• Primary Investigator: Open
• Status: Investigator being sought

32. ACL Laxity Correction
• Partial ACL tear by MRI + No symptoms opposite knee
• KT-2000 confirms 2 mm or greater side to side anterior
displacement difference with legs in neutral rotation.
• 9 ml 25% Dex. Inj. • Delayed
@ 0, 1, and 2 mo Treatment
with HRUS
• Blinded 3 month KT-1000 ADD.
• Inject at 3 months and • Inject at 3, 4, 5 and 6
then PRN symptoms at months and PRN at
6, and 9 months 9 months.
Blinded 12 month KT-1000 ADD

33. Morton’s Neuroma
• Location: Potential Brisbane
• Primary Investigator: Potential
podiatrist.
• Status: Investigator recruitment
stage
• Design: In preliminary stages

34. Study Name
• Location
• Primary Investigator:
• Status
• Design