Myogenous Temporomandibular Disorders (mTMD)NCT04704102
Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain
A study testing Muscle energy technique (MET) and Strain-counterstrain (SCS) in people with Myogenous Temporomandibular Disorders (mTMD), run by Chang Gung University at 1 site in Taiwan.
Trial summary
This is a prospective case series study.There were 20 individuals with chronic neck pain accompanied by myogenous temporomandibular disorders(mTMD) from Linkou and Taoyuan Chang Gung hospitals, and Chang-Gung university. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Myogenous Temporomandibular Disorders (mTMD)
- What is being tested?
- Muscle energy technique (MET) and Strain-counterstrain (SCS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Jan 2021to 30 Jun 2021
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 20~65
- Self-report neck pain ≥3 months (pain occurs between superior nuchal line and 1st level of thoracic spine)
- At least one tender point at both Upper trapezius and Sternocleidomastoid muscles
- Diagnosed as mTMD according to the Diagnostic Criteria for Temporomandibular Disorders(DC/TMD)
Who cannot join
- Cognitive deficit
- Malignancy, infection, cervical or orthognathic surgery, acute pain, and history of trauma in craniocervical region
- Neurological problem or cervical radiculopathy/myelopathy
- Cervical instability with positive rotational alar ligament stress test and transverse ligament stress test, jaw dislocation
- Tooth implantation or extraction a week before study
- Vertebrobasilar insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective case series study.There were 20 individuals with chronic neck pain accompanied by myogenous temporomandibular disorders(mTMD) from Linkou and Taoyuan Chang Gung hospitals, and Chang-Gung university. The purpose of this study was, first, to investigate the effects of muscle energy technique (MET) or strain-counterstrain (SCS) applied on the tender or trigger points of neck muscles on improving pain and pressure pain sensitivity in neck and masticatory muscles, the maximal mouth-opening range of motion, chewing endurance, and head-neck-shoulder posture in patients with chronic neck pain accompanied by mTMD. Second, whether the significant effects could be reached within the four-week intervention duration.
- Being tested
- Muscle energy technique (MET), Strain-counterstrain (SCS), sham SCS
- Keywords
- myogenous temporomandibular disorders, neck pain, muscle energy technique, strain-counterstrain, head-neck posture
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle energy technique (MET)Behavioural
A manual therapy technique that uses the gentle muscle contractions of the patient to relax and lengthen muscles and normalize joint motion.
Strain-counterstrain (SCS)Behavioural
It's also called the "positional release technique", a manual therapy technique that passively positions the hypertonic (spasmed) muscles and dysfunctional joints in positions of shortened or comfort.
sham SCSBehavioural
SCS intervention that position with opposite site limb and direction, and with modified method as consider the easiness of a practitioner to press the tender points
| Study group | Role | What they receive |
|---|---|---|
| Muscle energy technique group | Experimental | Use one of the muscle energy technique methods -- postisometric relaxation technique(PIR) as the intervention method. Receives: Behavioral: Muscle energy technique (MET) |
| Strain-counterstrain group | Experimental | Use the Strain-counterstrain technique as the intervention method. Receives: Behavioral: Strain-counterstrain (SCS) |
| Control group | Sham comparator | Use the modified Strain-counterstrain technique as the intervention method. Receives: Behavioral: sham SCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity in neck and masticatory muscles
ask participants the self-report pain intensity with the NPRS scale
Measured: 4 weeks
Tenderness sensitivity in neck and masticatory muscles
measure the pressure pain threshold with digital pressure algometer
Measured: 4 weeks
Secondary outcomes (3)
Maximal mouth-opening
measure the maximal pain free mouth-opening distance
Measured: 4 weeks
Chewing endurance
test for 5 minutes with chewing gum in the affected site
Measured: 4 weeks
Head-neck-shoulder posture
measure the Head tilt angle(HTA), Craniovertebral angle(CVA) \& Forward shoulder angle (FSA) by Photography in sagittal plane
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start11 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myogenous Temporomandibular Disorders (mTMD)Studies 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
- Sequential
- Model description
- Include elements of both longitudinal (three groups) and cross-sectional (four-weeks intervention) research designs
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Yang-Hua, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704102
- Sponsor's protocol ID
- 2010280044
- Status last verified
- Jul 2021
- First submitted
- 8 Jan 2021
- Last updated
- 6 Aug 2021
- 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 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Soft Tissue Mobilization of Neck Muscles in Individuals With Myogenous Temporomandibular Disorders: Muscle Energy Technique and Strain-counterstrain
- ClinicalTrials.gov ID
- NCT04704102
- Acronym / sponsor ID
- 2010280044
- Keywords
- myogenous temporomandibular disorders, neck pain, muscle energy technique, strain-counterstrain, head-neck posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 Jan 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.
This is a prospective case series study.There were 20 individuals with chronic neck pain accompanied by myogenous temporomandibular disorders(mTMD) from Linkou and Taoyuan Chang Gung hospitals, and Chang-Gung university. The purpose of this study was, first, to investigate the effects of muscle energy technique (MET) or strain-counterstrain (SCS) applied on the tender or trigger points of neck muscles on improving pain and pressure pain sensitivity in neck and masticatory muscles, the maximal mouth-opening range of motion, chewing endurance, and head-neck-shoulder posture in patients with chronic neck pain accompanied by mTMD. Second, whether the significant effects could be reached within the four-week intervention duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Include elements of both longitudinal (three groups) and cross-sectional (four-weeks intervention) research designs
| Arm | Type | Receives |
|---|---|---|
| Muscle energy technique group | Experimental | Behavioral: Muscle energy technique (MET)Use one of the muscle energy technique methods -- postisometric relaxation technique(PIR) as the intervention method. |
| Strain-counterstrain group | Experimental | Behavioral: Strain-counterstrain (SCS)Use the Strain-counterstrain technique as the intervention method. |
| Control group | Sham comparator | Behavioral: sham SCSUse the modified Strain-counterstrain technique as the intervention method. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 20~65
- Self-report neck pain ≥3 months (pain occurs between superior nuchal line and 1st level of thoracic spine)
- At least one tender point at both Upper trapezius and Sternocleidomastoid muscles
- Diagnosed as mTMD according to the Diagnostic Criteria for Temporomandibular Disorders(DC/TMD)
Key exclusion criteria (6 listed)
- Cognitive deficit
- Malignancy, infection, cervical or orthognathic surgery, acute pain, and history of trauma in craniocervical region
- Neurological problem or cervical radiculopathy/myelopathy
- Cervical instability with positive rotational alar ligament stress test and transverse ligament stress test, jaw dislocation
- Tooth implantation or extraction a week before study
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 |
|---|---|---|
| Muscle energy technique (MET)A manual therapy technique that uses the gentle muscle contractions of the patient to relax and lengthen muscles and normalize joint motion. | Behavioural | Muscle energy technique group |
| Strain-counterstrain (SCS)It's also called the "positional release technique", a manual therapy technique that passively positions the hypertonic (spasmed) muscles and dysfunctional joints in positions of shortened or comfort. | Behavioural | Strain-counterstrain group |
| sham SCSSCS intervention that position with opposite site limb and direction, and with modified method as consider the easiness of a practitioner to press the tender points | Behavioural | Control group |
Primary outcome
Pain intensity in neck and masticatory muscles
Time frame: 4 weeks
ask participants the self-report pain intensity with the NPRS scale
Tenderness sensitivity in neck and masticatory muscles
Time frame: 4 weeks
measure the pressure pain threshold with digital pressure algometer
3 secondary outcomes
Maximal mouth-opening
Time frame: 4 weeks
Chewing endurance
Time frame: 4 weeks
Head-neck-shoulder posture
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle energy technique (MET) and Strain-counterstrain (SCS) in people with Myogenous Temporomandibular Disorders (mTMD), run by Chang Gung University at 1 site in Taiwan.
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 6 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: finished, as of the sponsor's last update on 6 Aug 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity in neck and masticatory muscles (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 6 Aug 2021.