Temporomandibular DisordersNCT04210921
Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders (TMD)
A study testing Acupuncture in people with Temporomandibular Disorders, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
This is a single-blinded, randomized controlled trial to explore the effectiveness of acupuncture in the treatment of the pain due to TMD using the latest diagnostic criteria combined with subjective and objective indexes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Jun 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain disorders in accordance with Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- Pain in the jaw, temple, in the ear, in front of ear or headache in the temple at any sides, and pain or headache modified (remission or aggravation) with movement at least 3 months.
- Cooperated in completing the clinical trial successfully without language and mental disorders.
Who cannot join
- Conditions that result in regional pain in temporomandibular joint.
- Autoimmune diseases that result in regional pain in the temporomandibular joint.
- Mental illness or substance abuse.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University
Beijing
About this study
Official title: Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders(TMD)
This is a single-blinded, randomized controlled trial to explore the effectiveness of acupuncture in the treatment of the pain due to TMD using the latest diagnostic criteria combined with subjective and objective indexes.
Read the detailed description
This is a single-blinded, randomized controlled clinical trial. A total of 60 participants will be randomly assigned to two different groups. The treatment group will receive acupuncture with real penetration of the needle, while participants in the control group will be treated with the Park sham needle. All participants will be given for 4 weeks of treatment and 4 weeks of follow-up.The primary end-point is the reducing in intensity of pain due to TMD, which will be evaluated before treatment, 4 weeks after treatment and follow-up (4 weeks after treatment) by using 0-10 visual analogue score. Secondary end points include Graded Chronic Pain Scale Version 2.0(GCPS 2.0),Jaw Functional Limitations Scale - 20-item (JFLS-20),Depression, Anxiety and Stress Scales (DASS-21),Pittsburgh sleep quality index (PSQI),Pressure Pain Threshold (PPT),Surface electromyogram(sEMG).
- Conditions
- Temporomandibular Disorders
- Being tested
- Acupuncture, The park sham needle
- 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.
AcupunctureDevice
The acupuncture will be penetrated in an appropriate angle into a depth of 10-15 mm. Acupuncture manually manipulated by lifting, thrusting, and twirling methods to produce a characteristic sensation known as "De Qi" .
The park sham needleDevice
When the blunt needle goes through the adhesive and contact with skin, it will move back into the hollow centre of the handle rather than penetrate into skin.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | In the treatment group, the Park needle with a real acupuncture will be penetrated in an appropriate angle into a depth of 10-15 mm. Acupuncture manually manipulated by lifting, thrusting, and twirling methods to produce a characteristic sensation known as "De Qi" (feeling of needle sensation refers to tenseness around the needle felt by the practitioner and numbness, distension, soreness, and heaviness around the point felt by the patient), and needles will be stimulated manually at least 10 s, then the needles will be retained for 30 minutes. Receives: Device: Acupuncture |
| Control group | Placebo comparator | In the control group, the Park sham needle will instead of the real needle. It is retractile and adopts the sleeve type blunt needle design. When the blunt needle goes through the adhesive and contact with skin, it will move back into the hollow centre of the handle rather than penetrate into skin. The sham needle may be manipulated by lifting, thrusting or twirling as the real one, but it will not insert into the skin authentically. Receives: Device: The park sham needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale(VAS)
VAS is an international scale which reflects pain intensity and it has a 10-cm line ranging from 0 cm (no pain at all) to 10 cm (extremely painful). Pain intensity or pain relief in the tempormandibular joints will be measured by VAS. And then the investigators will compare the change of different time frames.The total score of this index is 10, and the better effect with the lower score.
Measured: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Secondary outcomes (6)
Graded Chronic Pain Scale Version 2.0(GCPS 2.0)
This scale includes the description of the degree of pain, a description of function, and a description of the time period of pain, which will provide effective data of the degree of pain within 1 month.The result of the index is divided into 5 grades. The less pain and influence with the lower the grade.
Measured: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Jaw Functional Limitations Scale - 20-item (JFLS-20)
This scale includes the evaluation of mastication limitation, the evaluation of vertical mobility limitation, the evaluation of verbal and nonverbal communication limitation.There are 20 items in this index, with a total score of 200 points. The better the mandibular function with the lower the score.
Measured: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Depression, Anxiety and Stress Scales (DASS-21)
This scale consists of three parts, 21 items in total. The total score of each part is 21 points. Less emotional distress with the lower the score.
Measured: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Pittsburgh sleep quality index (PSQI)
The total score of this scale is 21. The better the sleep quality with the lower score.
Measured: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Pressure Pain Threshold (PPT)
Participants will sit comfortably and relax their muscles during this measurement. A needle will be pressed at a constant speed perpendicular to the skin (0.5kg /cm2/second).The evaluator will be informed as soon as the participants feel pain and then record the results of measurement. The treatment is effective If the participants show elevated PPT after 4 weeks of treatment.
Measured: Baseline and Week- 4(treatment period)
Surface electromyogram(sEMG)
The electrodes will be placed parallel to the muscle fibers of the specify what muschemuscle.EMG signal acquisition will be performed in three tasks: mandibular resting position (MR), during maximal voluntary contraction (MVC), and during habitual chewing (HC).
Measured: Baseline and Week- 4(treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Apr 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li bin, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210921
- Sponsor's protocol ID
- 2018BL-060-01
- Status last verified
- Dec 2019
- First submitted
- 8 Nov 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Acupuncture in the Treatment of Temporomandibular Disorders(TMD)
- ClinicalTrials.gov ID
- NCT04210921
- Acronym / sponsor ID
- 2018BL-060-01
- Conditions
- Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 26 Dec 2019 (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.
This is a single-blinded, randomized controlled trial to explore the effectiveness of acupuncture in the treatment of the pain due to TMD using the latest diagnostic criteria combined with subjective and objective indexes.
Detailed description
This is a single-blinded, randomized controlled clinical trial. A total of 60 participants will be randomly assigned to two different groups. The treatment group will receive acupuncture with real penetration of the needle, while participants in the control group will be treated with the Park sham needle. All participants will be given for 4 weeks of treatment and 4 weeks of follow-up.The primary end-point is the reducing in intensity of pain due to TMD, which will be evaluated before treatment, 4 weeks after treatment and follow-up (4 weeks after treatment) by using 0-10 visual analogue score. Secondary end points include Graded Chronic Pain Scale Version 2.0(GCPS 2.0),Jaw Functional Limitations Scale - 20-item (JFLS-20),Depression, Anxiety and Stress Scales (DASS-21),Pittsburgh sleep quality index (PSQI),Pressure Pain Threshold (PPT),Surface electromyogram(sEMG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: AcupunctureIn the treatment group, the Park needle with a real acupuncture will be penetrated in an appropriate angle into a depth of 10-15 mm. Acupuncture manually manipulated by lifting, thrusting, and twirling methods to produce a characteristic sensation known as "De Qi" (feeling of needle sensation refers to tenseness around the needle felt by the practitioner and numbness, distension, soreness, and heaviness around the point felt by the patient), and needles will be stimulated manually at least 10 s, then the needles will be retained for 30 minutes. |
| Control group | Placebo comparator | Device: The park sham needleIn the control group, the Park sham needle will instead of the real needle. It is retractile and adopts the sleeve type blunt needle design. When the blunt needle goes through the adhesive and contact with skin, it will move back into the hollow centre of the handle rather than penetrate into skin. The sham needle may be manipulated by lifting, thrusting or twirling as the real one, but it will not insert into the skin authentically. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pain disorders in accordance with Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- Pain in the jaw, temple, in the ear, in front of ear or headache in the temple at any sides, and pain or headache modified (remission or aggravation) with movement at least 3 months.
- Cooperated in completing the clinical trial successfully without language and mental disorders.
Key exclusion criteria (4 listed)
- Conditions that result in regional pain in temporomandibular joint.
- Autoimmune diseases that result in regional pain in the temporomandibular joint.
- Mental illness or substance abuse.
- Pregnant women.
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 |
|---|---|---|
| AcupunctureThe acupuncture will be penetrated in an appropriate angle into a depth of 10-15 mm. Acupuncture manually manipulated by lifting, thrusting, and twirling methods to produce a characteristic sensation known as "De Qi" . | Device | Treatment group |
| The park sham needleWhen the blunt needle goes through the adhesive and contact with skin, it will move back into the hollow centre of the handle rather than penetrate into skin. | Device | Control group |
Primary outcome
Visual analogue scale(VAS)
Time frame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
VAS is an international scale which reflects pain intensity and it has a 10-cm line ranging from 0 cm (no pain at all) to 10 cm (extremely painful). Pain intensity or pain relief in the tempormandibular joints will be measured by VAS. And then the investigators will compare the change of different time frames.The total score of this index is 10, and the better effect with the lower score.
6 secondary outcomes
Graded Chronic Pain Scale Version 2.0(GCPS 2.0)
Time frame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Jaw Functional Limitations Scale - 20-item (JFLS-20)
Time frame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Depression, Anxiety and Stress Scales (DASS-21)
Time frame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Pittsburgh sleep quality index (PSQI)
Time frame: Baseline,Week- 4(treatment period) and Week-8(follow-up period)
Pressure Pain Threshold (PPT)
Time frame: Baseline and Week- 4(treatment period)
Surface electromyogram(sEMG)
Time frame: Baseline and Week- 4(treatment period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
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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 Acupuncture in people with Temporomandibular Disorders, run by Beijing Hospital of Traditional Chinese 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 3 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 Dec 2019. 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. Some participants in this study may receive a placebo. 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 Bin Li Dr (0086-18910781852, libin@bjzhongyi.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: Baseline,Week- 4(treatment period) and Week-8(follow-up period)). 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 Dec 2019.