Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection

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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders
• Intervention / Treatment: Other: Injection of 20% dextrose/ 0.2% lidocaine; Other: Injection of 1 ml of 0.8 SW/0.2% lidocaine

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 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1181
      • Hospital Italiano de Buenos Aires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Dextrose Injection	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	Other: Injection of 1 ml of 0.8 SW/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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Frusso, Ricardo, M.D.
• Collaborators: Zarate, Miguel, M.D.
• Investigators: Principal Investigator: Ricardo D Frusso, M.D., Hospital Italiano de Buenos Aires

Publications and helpful links

General Publications

• Zarate MA, Frusso RD, Reeves KD, Cheng AL, Rabago D. Dextrose Prolotherapy Versus Lidocaine Injection for Temporomandibular Dysfunction: A Pragmatic Randomized Controlled Trial. J Altern Complement Med. 2020 Nov;26(11):1064-1073. doi: 10.1089/acm.2020.0207. Epub 2020 Aug 11.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: June 5, 2012
• First Submitted That Met QC Criteria: June 11, 2012
• First Posted (ESTIMATE): June 12, 2012

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: TMD; prolotherapy; dextrose; temporomandibular
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Buenos Aires 1969