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Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders

Primary Purpose

Temporomandibular Joint Disorders

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low-Level Laser Therapy+acupuncture
Low-Level Laser Therapy
Sponsored by
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Low-Level Laser Therapy, acupuncture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Hospital of Integrated Traditional Chinese and Western MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-Level Laser Therapy+acupuncture

Low-Level Laser Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 .

Full Information

First Posted
March 23, 2021
Last Updated
March 25, 2021
Sponsor
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04819048
Brief Title
Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders
Official Title
Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Hospital of Integrated Traditional Chinese and Western Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Low-Level Laser Therapy, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Level Laser Therapy+acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-Level Laser Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Low-Level Laser Therapy+acupuncture
Intervention Description
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
Intervention Name(s)
Low-Level Laser Therapy
Intervention Description
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 Measure Information:
Title
Visual analogue scale(VAS)
Description
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.
Time Frame
Change from baseline Visual analogue scale at week 3
Secondary Outcome Measure Information:
Title
Tempommandibular Opening Index(TOI)
Description
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 .
Time Frame
Change from baseline Tempommandibular Opening Index at week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomei Wu
Phone
86-010-15810200766
Email
15810200766@163.com
Facility Information:
Facility Name
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DanYang Zhao, doctor
Phone
86-010-88223667
Email
kjk88223667@163.com

12. IPD Sharing Statement

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Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders

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