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
  Purpose

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.


Condition Intervention Phase
Temporomandibular Joint Disorders
Other: Injection of 20% dextrose/ 0.2% lidocaine
Other: Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy

Resource links provided by NLM:


Further study details as provided by Chisel Peak Medical Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dextrose 20 % Injection
Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint
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.
Active Comparator: Sterile Water Injection
Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706172

Contacts
Contact: W. Francois Louw, Doctor +1 250 341 6900 whatsupdok@shaw.ca
Contact: Shelly Hopkins, MOA +1 250 341 6900 shellyhopkins@chiselpeak.ca

Locations
Canada, British Columbia
Chisel Peak Medical Centre Recruiting
Invermere, British Columbia, Canada, V0A 1K0
Contact: Louw         
Principal Investigator: W. Francois Louw, Doctor         
Sponsors and Collaborators
Chisel Peak Medical Clinic
K. Dean Reeves, M.D.
Investigators
Principal Investigator: W. Francois Louw, Doctor University of British Columbia, Canada
  More Information

Publications:
Responsible Party: Dr. W Francois Louw, Clinical Instructor and Physician, University of British Columbia
ClinicalTrials.gov Identifier: NCT01706172     History of Changes
Other Study ID Numbers: TMJS
Study First Received: October 11, 2012
Last Updated: February 28, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Chisel Peak Medical Clinic:
TMD
temporomandibular
dextrose
prolotherapy

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 29, 2014