Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders

Temporomandibular Joint Disorders Clinical Trial

Official title:

Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04819048
• Other study ID #: HP2021-12-10202
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2021
• Source: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
• Contact: Xiaomei Wu
• Phone: 86-010-15810200766
• Email: 15810200766[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
China	Beijing Hospital of Integrated Traditional Chinese and Western Medicine	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tempommandibular Opening Index(TOI)	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 .	Change from baseline Tempommandibular Opening Index at week 3