Myofascial Trigger Point PainPhase 3NCT03993223
Upper Trapezius Myofascial Trigger Point in Overhead Athletes After Upper Trapezius Muscle Fatigue
A Phase 3 study testing Upper trapezius muscle fatigue in people with Myofascial Trigger Point Pain and Fatigue, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The healthy overhead athletes with and without upper trapezius myofascial trigger point will be asked to perform a scapular elevation task until the upper trapezius muscle fatigue. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Myofascial Trigger Point Pain, Fatigue
- What is being tested?
- Upper trapezius muscle fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jun 2019to 28 Feb 2022
- Phase
- Phase 3
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 years old active overhead athletes
- No symptoms in the shoulder of dominant side in the past 6 months
- Regularly perform overhead sports activity ≥ 3 hr/wk for more than 6 months
Who cannot join
- History of major shoulder/cervical injury or surgery in the past 6 months
- Experiencing shoulder pain, or participating in rehabilitation for shoulder pain in the past 6 months before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scapular Kinematic and Shoulder Muscle Activity Alterations in Overhead Athletes With/Without Upper Trapezius Myofascial Trigger Point After Muscle Fatigue
The healthy overhead athletes with and without upper trapezius myofascial trigger point will be asked to perform a scapular elevation task until the upper trapezius muscle fatigue. The first hypothesis is that the subjects with upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities when compared to subjects without upper trapezius myofascial trigger point. Besides, the investigators suggest that subjects with/without upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities after upper trapezius muscle fatigue, especially in subjects with upper trapezius myofascial trigger point.
Read the detailed description
The investigators will recruit healthy overhead athletes with and without upper trapezius myofascial trigger point. Participants will be asked to perform a sustained scapular elevation task at their peak force until the force decrease 50 %, which indicates upper trapezius muscle fatigue. There are two purposes in the current study: (1) to compare the differences between overhead athletes with/without upper trapezius myofascial trigger point during arm elevation in scapular kinematics and muscles activities (2) to investigate the effects of upper trapezius muscle fatigue on scapular kinematics and muscles activities in overhead athletes with/without upper trapezius myofascial trigger point. The first hypothesis is that the subjects with upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities when compared to subjects without upper trapezius myofascial trigger point. Besides, the investigators suggest that subjects with/without upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities after upper trapezius muscle fatigue, especially in subjects with upper trapezius myofascial trigger point. The outcome measurements includes scapular kinematics (upward/downward rotation, external/internal rotation, posterior/anterior tilting) and muscles activities (upper trapezius, serratus anterior, lower trapezius).
- Conditions
- Myofascial Trigger Point Pain, Fatigue
- Being tested
- Upper trapezius muscle fatigue
- Keywords
- Upper trapezius, Myofascial Trigger Point, Muscle fatigue, Overhead athlete
- Medical subject headings
- Myofascial Pain Syndromes, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper trapezius muscle fatigueBehavioural
Isometric contraction of scapular elevation
| Study group | Role | What they receive |
|---|---|---|
| MTrP group | Experimental | Healthy overhead athletes with upper trapezius myofascial trigger point Receives: Behavioral: Upper trapezius muscle fatigue |
| Control group | Sham comparator | Healthy overhead athletes without upper trapezius myofascial trigger point Receives: Behavioral: Upper trapezius muscle fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scapular kinematics
Change of scapular kinematics immediately after fatigue task
Measured: 10 minutes
Scapular muscles electromyography
Change of scapular muscles electromyography immediately after fatigue task
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start17 Jun 2019
- Primary completion31 May 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger Point PainStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment allocation and procedures involved in this randomized study were explained to all participants when they met inclusion criteria of VAS score of 4 or greater on the postoperative first day.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993223
- Sponsor's protocol ID
- 201904021RIND
- Status last verified
- Feb 2022
- First submitted
- 12 Jun 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scapular Kinematic and Shoulder Muscle Activity Alterations in Overhead Athletes With/Without Upper Trapezius Myofascial Trigger Point After Muscle Fatigue
- ClinicalTrials.gov ID
- NCT03993223
- Acronym / sponsor ID
- 201904021RIND
- Conditions
- Myofascial Trigger Point Pain, Fatigue
- Keywords
- Upper trapezius, Myofascial Trigger Point, Muscle fatigue, Overhead athlete
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 20 Jun 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.
The healthy overhead athletes with and without upper trapezius myofascial trigger point will be asked to perform a scapular elevation task until the upper trapezius muscle fatigue. The first hypothesis is that the subjects with upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities when compared to subjects without upper trapezius myofascial trigger point. Besides, the investigators suggest that subjects with/without upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities after upper trapezius muscle fatigue, especially in subjects with upper trapezius myofascial trigger point.
Detailed description
The investigators will recruit healthy overhead athletes with and without upper trapezius myofascial trigger point. Participants will be asked to perform a sustained scapular elevation task at their peak force until the force decrease 50 %, which indicates upper trapezius muscle fatigue. There are two purposes in the current study: (1) to compare the differences between overhead athletes with/without upper trapezius myofascial trigger point during arm elevation in scapular kinematics and muscles activities (2) to investigate the effects of upper trapezius muscle fatigue on scapular kinematics and muscles activities in overhead athletes with/without upper trapezius myofascial trigger point. The first hypothesis is that the subjects with upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities when compared to subjects without upper trapezius myofascial trigger point. Besides, the investigators suggest that subjects with/without upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities after upper trapezius muscle fatigue, especially in subjects with upper trapezius myofascial trigger point. The outcome measurements includes scapular kinematics (upward/downward rotation, external/internal rotation, posterior/anterior tilting) and muscles activities (upper trapezius, serratus anterior, lower trapezius).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The treatment allocation and procedures involved in this randomized study were explained to all participants when they met inclusion criteria of VAS score of 4 or greater on the postoperative first day.
| Arm | Type | Receives |
|---|---|---|
| MTrP group | Experimental | Behavioral: Upper trapezius muscle fatigueHealthy overhead athletes with upper trapezius myofascial trigger point |
| Control group | Sham comparator | Behavioral: Upper trapezius muscle fatigueHealthy overhead athletes without upper trapezius myofascial trigger point |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-50 years old active overhead athletes
- No symptoms in the shoulder of dominant side in the past 6 months
- Regularly perform overhead sports activity ≥ 3 hr/wk for more than 6 months
Key exclusion criteria (2 listed)
- History of major shoulder/cervical injury or surgery in the past 6 months
- Experiencing shoulder pain, or participating in rehabilitation for shoulder pain in the past 6 months before the 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 |
|---|---|---|
| Upper trapezius muscle fatigueIsometric contraction of scapular elevation | Behavioural | Control group, MTrP group |
Primary outcome
Scapular kinematics
Time frame: 10 minutes
Change of scapular kinematics immediately after fatigue task
Scapular muscles electromyography
Time frame: 10 minutes
Change of scapular muscles electromyography immediately after fatigue task
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 2 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Phase 3 study testing Upper trapezius muscle fatigue in people with Myofascial Trigger Point Pain and Fatigue, run by National Taiwan University Hospital 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 3 inclusion and 2 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 2 Mar 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Scapular kinematics (time frame: 10 minutes). 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 2 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.