Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
Primary Purpose
Temporomandibular Joint Disorders
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Injection of 20% dextrose/ 0.2% lidocaine
Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring TMD, temporomandibular, dextrose, prolotherapy
Eligibility Criteria
Inclusion Criteria:
more than 3 month history of :
- Facial Pain NRS rating > 5/10
- Jaw symptom rating > 5/10
- Jaw function issues seen on examination
Exclusion Criteria:
- 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.
Sites / Locations
- Chisel Peak Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dextrose 20 % Injection
Sterile Water Injection
Arm Description
Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint
Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.
TMJ injection of 20% dextrose will result in significantly more improvement in Jaw Dysfunction at 3 months. Jaw dysfunction is rated based on the worst of the following: Chewing difficulty, jaw tension or stiffness, fatigue with eating, or grinding noises
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
Full Information
NCT ID
NCT01706172
First Posted
October 11, 2012
Last Updated
January 31, 2017
Sponsor
Chisel Peak Medical Clinic
Collaborators
K. Dean Reeves, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT01706172
Brief Title
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
Official Title
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chisel Peak Medical Clinic
Collaborators
K. Dean Reeves, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of symptom diminishment, especially in the elderly. However studies out to 2-8 years show residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been utilized empirically for many years and a marked reduction in pain and luxation after intra-articular and pericapsular dextrose injection has been reported in a recent RCT. However, small study size and lack of a non injection control have prevented any definitive conclusions as the additional efficacy of including dextrose in the injectate. The mechanism of action of dextrose injection was originally thought to be via a brief stimulation of the inflammatory cascade with resultant production of growth factors. However, non-inflammatory dextrose effects on growth factor production have been demonstrated, and, more recently, dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). This has the theoretical benefit of reducing pain, regardless of the status and position of the intraarticular cartilage or degree of degenerative change of the TMD. The primary goal of this study is to evaluate the ability of dextrose injection versus saline injection to reduce pain and improve functional complaints referable to the temporomandibular joint.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
TMD, temporomandibular, dextrose, prolotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dextrose 20 % Injection
Arm Type
Active Comparator
Arm Description
Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint
Arm Title
Sterile Water Injection
Arm Type
Active Comparator
Arm Description
Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint
Intervention Type
Other
Intervention Name(s)
Injection of 20% dextrose/ 0.2% lidocaine
Intervention Description
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.
Intervention Type
Other
Intervention Name(s)
Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine
Intervention Description
Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine
Primary Outcome Measure Information:
Title
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain
Description
TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.
Description
TMJ injection of 20% dextrose will result in significantly more improvement in Jaw Dysfunction at 3 months. Jaw dysfunction is rated based on the worst of the following: Chewing difficulty, jaw tension or stiffness, fatigue with eating, or grinding noises
Time Frame
3 Months
Title
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
Description
TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
more than 3 month history of :
Facial Pain NRS rating > 5/10
Jaw symptom rating > 5/10
Jaw function issues seen on examination
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Francois Louw, Doctor
Organizational Affiliation
University of British Columbia, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chisel Peak Medical Centre
City
Invermere
State/Province
British Columbia
ZIP/Postal Code
V0A 1K0
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21757278
Citation
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.
Results Reference
background
PubMed Identifier
22759069
Citation
Dumais 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.
Results Reference
background
PubMed Identifier
22515800
Citation
Rabago 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.
Results Reference
background
PubMed Identifier
21969284
Citation
Topol 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.
Results Reference
background
PubMed Identifier
30878157
Citation
Louw 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.
Results Reference
derived
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Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
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