Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders

NCT04819048 | Unknown DMC

• 1 other identifier: HP2021-12-10202
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Keywords

Low-Level Laser Therapy; acupuncture

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale(VAS)

  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.

  Change from baseline Visual analogue scale at week 3

Secondary Outcomes (1)

• Tempommandibular Opening Index(TOI)

  Change from baseline Tempommandibular Opening Index at week 3

Study Arms (2)

Low-Level Laser Therapy+acupuncture

EXPERIMENTAL

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.

Device: Low-Level Laser Therapy+acupuncture

Low-Level Laser Therapy

ACTIVE COMPARATOR

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.

Device: Low-Level Laser Therapy

Interventions

Low-Level Laser Therapy+acupuncture DEVICE

The experimental group will be firstly irradiated by the GaAlAs infrared laser (CDHC,Denlase 980/7 Diode Laser Therapy System,China), with an output of 500 mW, emitting radiation wavelength of 980 nm, spot size 0.2cm2 ,15J/point, in a continuous mode .The therapeutic LLLT application is achieved through direct contact of the probe on the skin. The needles using are disposable, sterile, individually packed, and made of stainless steel (Hua Tuo; Suzhou Medical Supplies Factory Co, Ltd,Suzhou, China), in sizes 0.25 mm ×40 mm.Asepsis of the skin will be performed with cotton wool and 75% alcohol.

Low-Level Laser Therapy+acupuncture

Low-Level Laser Therapy DEVICE

The experimental group will be firstly irradiated by the GaAlAs infrared laser (CDHC,Denlase 980/7 Diode Laser Therapy System,China), with an output of 500 mW, emitting radiation wavelength of 980 nm, spot size 0.2cm2 ,15J/point, in a continuous mode .The therapeutic LLLT application is achieved through direct contact of the probe on the skin.

Low-Level Laser Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Hospital of Integrated Traditional Chinese and Western Medicine: lead

Study Sites (1)

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Beijing, Beijing Municipality, 100039, China

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Xiaomei Wu

CONTACT

86-010-15810200766; 15810200766@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: April 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 26, 2021

Record last verified: 2021-03

Locations

CN (1)