Clinical trial NCT01706172: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Temporomandibular Joint Disorders
Keywords: TMD
temporomandibular
dextrose
prolotherapy
Lead sponsor: Chisel Peak Medical Clinic
Sponsor class: OTHER
Collaborators: name: K. Dean Reeves, M.D.
First posted: 2012-10-15
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Pain
timeFrame: 3 Months
Secondary outcomes:
measure: Change from baseline to 3 months in Numerical Rating Scale (NRS) for Jaw Dysfunction.
timeFrame: 3 Months
measure: TMJ injection of 20% dextrose will result in sustainable improvement in Jaw Pain to 1 year follow-up.
timeFrame: 1 year
Other outcomes:
Locations:
city: Invermere
country: Canada
facility: Chisel Peak Medical Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia, Canada
name: W. Francois Louw, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.