Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

Study Overview
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Brief Summary
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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 be notably helpful in preliminary studies in reducing pain and improving jaw function. This randomized trial will compare dextrose injection with saline injection for temporomandibular(jaw) dysfunction, also known as TMD.

Detailed Description
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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 intraarticular 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.

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

Conditions
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Temporomandibular Joint Disorders

Intervention / Treatment
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* Other: Injection of 20% dextrose/ 0.2% lidocaine
* Other: Injection of 1 ml of 0.8 SW/0.2% lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dextrose Injection<br> | Other: Injection of 20% dextrose/ 0.2% lidocaine<br>* Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.<br>|
| Active Comparator: Sterile Water Injection<br> | Other: Injection of 1 ml of 0.8 SW/0.2% lidocaine<br>* Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for Jaw Pain | Anchors include 0 = no pain and 10 = worst pain imaginable An improvement is a reduction in the NRS scale. | 3 months | 
| 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for Jaw pain from baseline to 3 months | Anchors include 0 = no pain and 10 = worst pain imaginable. A 50% reduction in the 0-10 NRS is a clinically important outcome. | 3 months | 
| Change from baseline to 3 months in a 0-10 Numerical Rating Scale (NRS) for jaw dysfunction. | Anchors include 0 = no pain and 10 = worst pain imaginable An improvement is a reduction in the NRS scale. | 3 months | 
| 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction to 3 months | Anchors include 0 = no pain and 10 = worst pain imaginable. A 50% reduction in the 0-10 NRS is a clinically important outcome. | 3 months | 
| Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for jaw pain | Anchors include 0 = no pain and 10 = worst pain imaginable An improvement is a reduction in the NRS scale. | 1 year | 
| 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw pain from baseline to 1 year | Anchors include 0 = no pain and 10 = worst pain imaginable. A 50% reduction in the 0-10 NRS is a clinically important outcome. | 1 year | 
| Change from baseline to 1 year in a 0-10 Numerical Rating Scale (NRS) for Jaw Dysfunction | Anchors include 0 = no pain and 10 = worst pain imaginable An improvement is a reduction in the NRS scale. | 1 year | 
| 50% or more improvement in 0-10 Numerical Rating Scale (NRS) for for jaw dysfunction from baseline to 1 year | Anchors include 0 = no pain and 10 = worst pain imaginable. A 50% reduction in the 0-10 NRS is a clinically important outcome. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mouth opening in millimeters from baseline to 3 months as manually measured by a Therabite. | An increase in mouth opening in millimeters is considered an improvement in this study. | 3 months | 
| Satisfaction to 3 months as measured by a 0-10 Numerical Rating Scale (NRS) | Anchors include 0 = no satisfaction and 10 = complete satisfaction | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMD, temporomandibular, dextrose, prolotherapy