Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Overview

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.

Full Title of Study: “Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2016

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Dextrose 20 % Injection
    • Injecting 20 % Dextrose and 0.2 % lidocaine intra-articularly into the TM Joint
  • Active Comparator: Sterile Water Injection
    • Injection of Sterile water in 0.2 % lidocaine intra-articularly into the TM joint

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain
    • Time Frame: 3 Months
    • TMJ injection of 20% dextrose will result in significantly more pain relief at 3 months than injection of .2% lidocaine.

Secondary Measures

  • Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.
    • Time Frame: 3 Months
    • 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
    • TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chisel Peak Medical Clinic
  • Collaborator
    • K. Dean Reeves, M.D.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. W Francois Louw, Clinical Instructor and Physician – University of British Columbia
  • Overall Official(s)
    • W. Francois Louw, Doctor, Principal Investigator, University of British Columbia, Canada

References

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.

Dumais R, Benoit C, Dumais A, Babin L, Bordage R, de Arcos C, Allard J, BĂ©langer 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.

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.

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.

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