Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders

Not Applicable

• Conditions: Temporomandibular Joint Disorders
• Interventions: Device: Low-Level Laser Therapy+acupuncture; Device: Low-Level Laser Therapy

• Registration Number: NCT04819048
• Lead Sponsor: Beijing Hospital of Integrated Traditional Chinese and Western Medicine

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.

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Study First Posted: 2021-03-26
• Last Update Posted: 2021-03-26
• Study Start: 2021-04-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. 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.
2. Aged 18-65;
3. Unilaterally;
4. No any other treatment on TMD in the last 3 months;

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Level Laser Therapy+acupuncture	Low-Level Laser Therapy+acupuncture	The laser light will be applied in 6 points on the affected side: anterior to the mandibular condyle and intraauricular toward the temporomandibular joint; 2 points irradiation on the superficial masseter muscle and 2 points on the anterior temporal muscle bundle. Each point will be irradiated for 30 seconds for a total of 180 seconds. After LLLT irradiation,the following acupuncture points will be selected: Jiache,Xiaguan,Quanliao,Baihui,Fengchi, Hegu.The needles will be inserted and rotated manually with a frequency of about 100 turns per minute clockwise and counterclockwise ,as above vertically into a depth of 25-30 mm to achieve the proper feel called "Deqi" in every point on the affected side, and then the needles will be retained for 30 minutes.
Low-Level Laser Therapy	Low-Level Laser Therapy	The laser light will be applied in 6 points on the affected side: anterior to the mandibular condyle and intraauricular toward the temporomandibular joint; 2 points irradiation on the superficial masseter muscle and 2 points on the anterior temporal muscle bundle. Each point will be irradiated for 30 seconds for a total of 180 seconds.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale(VAS)	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 Outcome Measures

Name	Time	Method
Tempommandibular Opening Index(TOI)	Change from baseline Tempommandibular Opening Index at week 3	TOI=(Maximum voluntary opening-passive opening)/Maximum voluntary opening+Passive opening)× 100％.; The maximum mouth opening without pain will be recorded by placing a millimeter ruler in a vertical position, from the incisal edge of the maxillary left central incisor to the incisal edge of the mandibular left central incisor.; Based on the the maximum opening, the researcher uses thumb and forefinger slowly against the upper and lower incisor , with soft and stable pressure until the distance no longer increases .This is called the passive opening .

Trial Locations

Locations (1)

Beijing Hospital of Integrated Traditional Chinese and Western Medicine; 🇨🇳 Beijing, Beijing, China