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Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Chisel Peak Medical Clinic
Sponsor:
Collaborator:
K. Dean Reeves, M.D.
Information provided by (Responsible Party):
Dr. W Francois Louw, University of British Columbia
ClinicalTrials.gov Identifier:
NCT01706172
First received: October 11, 2012
Last updated: February 28, 2013
Last verified: February 2013

October 11, 2012
February 28, 2013
January 2013
January 2014   (final data collection date for primary outcome measure)
Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.
Same as current
Complete list of historical versions of study NCT01706172 on ClinicalTrials.gov Archive Site
  • Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
Same as current
Not Provided
Not Provided
 
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Temporomandibular Joint Disorders
  • Other: Injection of 20% dextrose/ 0.2% lidocaine
    Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.
  • Other: Injection of 1 ml of 0.8 Sterile water /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
  • Active Comparator: Dextrose 20 % Injection
    Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint
    Intervention: Other: Injection of 20% dextrose/ 0.2% lidocaine
  • Active Comparator: Sterile Water Injection
    Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint
    Intervention: Other: Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
19 Years to 90 Years
Yes
Contact: W. Francois Louw, Doctor +1 250 341 6900 whatsupdok@shaw.ca
Contact: Shelly Hopkins, MOA +1 250 341 6900 shellyhopkins@chiselpeak.ca
Canada
 
NCT01706172
TMJS
Yes
Dr. W Francois Louw, University of British Columbia
Chisel Peak Medical Clinic
K. Dean Reeves, M.D.
Principal Investigator: W. Francois Louw, Doctor University of British Columbia, Canada
Chisel Peak Medical Clinic
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP