Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders

NCT ID: NCT04819048

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-12-31

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.

Conditions

Temporomandibular Joint Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low-Level Laser Therapy+acupuncture

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Low-Level Laser Therapy

Intervention Type: 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.

Interventions

Low-Level Laser Therapy+acupuncture

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.

Intervention Type: DEVICE

Low-Level Laser Therapy

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaomei Wu

Role: CONTACT

15810200766@163.com

86-010-15810200766

Facility Contacts

DanYang Zhao, doctor

Role: primary

kjk88223667@163.com

86-010-88223667

Other Identifiers

HP2021-12-10202

Identifier Type: -

Identifier Source: org_study_id