Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
1 other identifier
interventional
42
1 country
1
Brief Summary
Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be quite long lasting and debilitating. Dextrose injection with a small needle has been notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with sterile water injection for temporomandibular(jaw) dysfunction, also known as TMD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFebruary 2, 2017
January 1, 2017
3.2 years
October 11, 2012
January 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain
TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.
3 Months
Secondary Outcomes (2)
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.
3 Months
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
1 year
Study Arms (2)
Dextrose 20 % Injection
ACTIVE COMPARATORInjecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint
Sterile Water Injection
ACTIVE COMPARATORInjection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint
Interventions
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine
Eligibility Criteria
You may qualify if:
- more than 3 month history of :
- Facial Pain NRS rating \> 5/10
- Jaw symptom rating \> 5/10
- Jaw function issues seen on examination
You may not qualify if:
- Any potential acute dental issue
- Rheumatic inflammatory disease
- Chronic intake of NSAIDs or corticosteroids.
- Pain in other body location worse than jaw pain
- Pain 10/10 in other body location.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chisel Peak Medical Cliniclead
- K. Dean Reeves, M.D.collaborator
Study Sites (1)
Chisel Peak Medical Centre
Invermere, British Columbia, V0A 1K0, Canada
Related Publications (5)
Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec;69(12):2962-70. doi: 10.1016/j.joms.2011.02.128. Epub 2011 Jul 16.
PMID: 21757278BACKGROUNDDumais R, Benoit C, Dumais A, Babin L, Bordage R, de Arcos C, Allard J, Belanger M. Effect of regenerative injection therapy on function and pain in patients with knee osteoarthritis: a randomized crossover study. Pain Med. 2012 Aug;13(8):990-9. doi: 10.1111/j.1526-4637.2012.01422.x. Epub 2012 Jul 3.
PMID: 22759069BACKGROUNDRabago D, Zgierska A, Fortney L, Kijowski R, Mundt M, Ryan M, Grettie J, Patterson JJ. Hypertonic dextrose injections (prolotherapy) for knee osteoarthritis: results of a single-arm uncontrolled study with 1-year follow-up. J Altern Complement Med. 2012 Apr;18(4):408-14. doi: 10.1089/acm.2011.0030.
PMID: 22515800BACKGROUNDTopol GA, Podesta LA, Reeves KD, Raya MF, Fullerton BD, Yeh HW. Hyperosmolar dextrose injection for recalcitrant Osgood-Schlatter disease. Pediatrics. 2011 Nov;128(5):e1121-8. doi: 10.1542/peds.2010-1931. Epub 2011 Oct 3.
PMID: 21969284BACKGROUNDLouw WF, Reeves KD, Lam SKH, Cheng AL, Rabago D. Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection (Prolotherapy): A Randomized Controlled Trial With Long-term Partial Crossover. Mayo Clin Proc. 2019 May;94(5):820-832. doi: 10.1016/j.mayocp.2018.07.023. Epub 2019 Mar 14.
PMID: 30878157DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
W. Francois Louw, Doctor
University of British Columbia, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Instructor and Physician
Study Record Dates
First Submitted
October 11, 2012
First Posted
October 15, 2012
Study Start
January 1, 2013
Primary Completion
March 1, 2016
Study Completion
June 1, 2016
Last Updated
February 2, 2017
Record last verified: 2017-01