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Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders

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ClinicalTrials.gov Identifier: NCT04819048
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Device: Low-Level Laser Therapy+acupuncture Device: Low-Level Laser Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

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.


Active Comparator: 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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Tempommandibular Opening Index(TOI) [ Time Frame: 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 .




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819048


Contacts
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Contact: Xiaomei Wu 86-010-15810200766 15810200766@163.com

Locations
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China, Beijing
Beijing Hospital of Integrated Traditional Chinese and Western Medicine Recruiting
Beijing, Beijing, China, 100039
Contact: DanYang Zhao, doctor    86-010-88223667    kjk88223667@163.com   
Sponsors and Collaborators
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
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Responsible Party: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
ClinicalTrials.gov Identifier: NCT04819048    
Other Study ID Numbers: HP2021-12-10202
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Hospital of Integrated Traditional Chinese and Western Medicine:
Low-Level Laser Therapy
acupuncture
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Joint Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes