Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Temporomandibular Joint Disorders Clinical Trial

Official title:

Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection: A Randomised Clinical Trial of Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706172
• Other study ID #: TMJS
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 11, 2012
• Last updated: January 31, 2017
• Start date: January 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Chisel Peak Medical Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.
• 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

Locations

Country	Name	City	State
Canada	Chisel Peak Medical Centre	Invermere	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Chisel Peak Medical Clinic	K. Dean Reeves, M.D.

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Dumais R, Benoit C, Dumais A, Babin L, Bordage R, de Arcos C, Allard J, Bélanger 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 Months
Secondary	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	3 Months
Secondary	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.	1 year