Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Sponsor

Chisel Peak Medical Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01706172

Collaborator

K. Dean Reeves, M.D. (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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