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Clinical Trials/NCT04819048
NCT04819048
Unknown
Not Applicable

Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders

Beijing Hospital of Integrated Traditional Chinese and Western Medicine1 site in 1 country96 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Temporomandibular Joint Disorders
Sponsor
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Enrollment
96
Locations
1
Primary Endpoint
Visual analogue scale(VAS)
Last Updated
5 years ago

Overview

Brief Summary

Temporomandibular joint disorders (TMD) , a musculoskeletal condition , includes a series of clinical problems involving the temporomandibular joint (TMJ), the masticatory muscles, and related structures.This study evaluates the efficacy of integrated traditional Chinese and western medicine in the treatment of TMD.

Detailed Description

In this study, 84 patients ranging in age from 18 to 65 years with diagnoses of TMD will be randomly divided into two groups: an experimental group (EG) who will receive the integrated traditional Chinese and western medicine treatment group(with Low-Level Laser Therapy+acupuncture) and a control group who will receive the only western medicine treatment(with Low-Level Laser Therapy).Both approaches will be applied 3times a week for 3 weeks.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
December 31, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • diagnosis of TMD according to the Diagnostic Criteria for TMD Research Diagnostic Criteria (DC/TMD)which are manifested as joint pain during mouth opening and chewing, mouth opening limitation (\<40mm), joint clanging, masticatory creatine distension and weakness, which affects normal eating.
  • Aged 18-65;
  • Unilaterally;
  • No any other treatment on TMD in the last 3 months;

Exclusion Criteria

  • there are tumors, joint degeneration and other serious lesions ;
  • Patients with a history of TMJ trauma or surgery,joint anatomical variation;
  • women pregnant and suckling period;
  • serious systemic diseases of bone and joint, such as rheumatoid arthritis

Outcomes

Primary Outcomes

Visual analogue scale(VAS)

Time Frame: Change from baseline Visual analogue scale at week 3

TMD pain will be quantified by the VAS, which is a 10-cm line ranging from 0 cm (no pain at all) to 10 cm (the worst possible pain). The patients are instructed to choose the grade of their spontaneous pain intensity on the 10 points scale during resting, mouth opening, and chewing.And then the operator takes the maximum from that.

Secondary Outcomes

  • Tempommandibular Opening Index(TOI)(Change from baseline Tempommandibular Opening Index at week 3)

Study Sites (1)

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