Temporomandibular Joint DisordersNCT04819048
Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders
A study testing Low-Level Laser Therapy+acupuncture and Low-Level Laser Therapy in people with Temporomandibular Joint Disorders, run by Beijing Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Low-Level Laser Therapy+acupuncture and Low-Level Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Beijing, Beijing Municipality, 100039
DanYang Zhao, doctor, 86-010-88223667, kjk88223667@163.com
About this study
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.
Read the 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
- Being tested
- Low-Level Laser Therapy+acupuncture, Low-Level Laser Therapy
- Keywords
- Low-Level Laser Therapy, acupuncture
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser Therapy+acupunctureDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Low-Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline Visual analogue scale at week 3
Secondary outcomes (1)
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 .
Measured: Change from baseline Tempommandibular Opening Index at week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Integrated Traditional Chinese and Western Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819048
- Sponsor's protocol ID
- HP2021-12-10202
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture and Low-Level Laser in Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04819048
- Acronym / sponsor ID
- HP2021-12-10202
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Low-Level Laser Therapy, acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Beijing Hospital of Integrated Traditional Chinese and Western MedicineUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Level Laser Therapy+acupuncture | Experimental | Device: Low-Level Laser Therapy+acupunctureThe 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. |
| Low-Level Laser Therapy | Active comparator | Device: Low-Level Laser TherapyThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Level Laser Therapy+acupunctureThe 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. | Device | Low-Level Laser Therapy+acupuncture |
| Low-Level Laser TherapyThe 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. | Device | Low-Level Laser Therapy |
Primary outcome
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.
1 secondary outcome
Tempommandibular Opening Index(TOI)
Time frame: Change from baseline Tempommandibular Opening Index at week 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy+acupuncture and Low-Level Laser Therapy in people with Temporomandibular Joint Disorders, run by Beijing Hospital of Integrated Traditional Chinese and Western Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomei Wu (86-010-15810200766, 15810200766@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale(VAS) (time frame: Change from baseline Visual analogue scale at week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.