Myofascial Pain of Upper Trapezius MuscleNCT05987683
The Efficacy of Thread Embedding Acupuncture on Pain Score, Neck Disability Index, and Pressure Pain Threshold for Myofascial Pain Therapy in the Upper Trapezius Muscle
A study of Myofascial Pain of Upper Trapezius Muscle, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
Myofascial pain is characterized by myofascial trigger points, considered as a major cause of neck and shoulder pain in the working population. Thread-embedding acupuncture is a new acupuncture modality that can provide long-term stimulation aimed at prolonging its therapeutic effect that is similar to conventional… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Myofascial Pain of Upper Trapezius Muscle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesIndonesia
- Study dates
- 21 Aug 2023to 31 Oct 2023
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female aged 18-59 years.
- Subject with myofascial pain in the upper trapezius muscle.
- VAS score of 30-70 mm from 100 mm during activities (everyday activities or light exercise).
- Pain > 3 months.
- Willing to participate in this research to completion and sign informed consent.
Who cannot join
- Fibromyalgia.
- Have had cervical spine surgery.
- Have done Dry needling therapy on the upper trapezius muscle in the last 9 days
- Have done thread acupuncture on the upper trapezius muscle in the last 6 months.
- Have performed pharmacopuncture on the upper trapezius muscle in the last 6 months.
- VAS score is more than 70 mm than 100 mm at resting.
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- History of anti-inflammatory drug treatment in the previous 2 weeks.
- History of intra-articular steroid injections in the previous 3 months.
- There is a tumor, wound, or skin infection at the needle insertion area.
- Fever (≥ 37.5 oC).
- There is a hypersensitivity reaction in previous acupuncture therapy (metal allergy, severe atopy, keloids, or other skin hypersensitivity).
- Suffering from a blood disorder or taking blood thinners (anti-platelet or anti-coagulant drugs).
- Have a heart condition or uncontrolled diabetes.
- Blood glucose level (GDS) ≥200 mg/dL is checked by capillary blood using a glucometer.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, 10430
Persahabatan Hospital
Jakarta, DKI Jakarta, 13230
About this study
Myofascial pain is characterized by myofascial trigger points, considered as a major cause of neck and shoulder pain in the working population. Thread-embedding acupuncture is a new acupuncture modality that can provide long-term stimulation aimed at prolonging its therapeutic effect that is similar to conventional acupuncture, such as analgesic effects. The goal of this randomized controlled trial is to evaluate and compare the effects of thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the upper trapezius muscle. The primary aim of this study is to investigate whether thread-embedding acupuncture therapy gives better and last longer results for myofascial pain of the upper trapezius muscle than sham thread-embedding acupuncture.
Read the detailed description
This is a clinical trial study to evaluate and compare the effects of thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the upper trapezius muscle. The subjects are 44 males/female with myofascial pain in the upper trapezius muscle and will be randomly assigned to 2 groups: (1) thread-embedding acupuncture and (2) Sham thread-embedding acupuncture. The subjects will receive a single treatment. The outcome will be assessed before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment. Patients and the outcome assessors will be blinded to the group allocation.
- Being tested
- Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread-Embedding Acupuncture, Sham Thread-Embedding AcupunctureProcedure or surgery
Thread-Embedding Acupuncture: using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread Sham Thread-Embedding Acupuncture: using a 29-gauge TEA needle but thread-removed, just needle alone
| Study group | Role | What they receive |
|---|---|---|
| Thread-Embedding Acupuncture | Experimental | Thread-Embedding Acupuncture using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread Receives: Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture |
| Sham Thread-Embedding Acupuncture | Sham comparator | Sham Thread-Embedding Acupuncture using a 29-gauge TEA needle but thread-removed, just needle alone Receives: Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain rating scale for measuring pain
Measured: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
Secondary outcomes (2)
Neck Disability Index
A questionnaire for measuring self-rated disability due to neck pain
Measured: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
Pressure Pain Threshold
Using the minimum force applied which induces pain, measured with algometer
Measured: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start21 Aug 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain of Upper Trapezius MuscleStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emilia Puspitasari Winarno, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987683
- Sponsor's protocol ID
- 23060907
- Status last verified
- Dec 2023
- First submitted
- 26 Jul 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Thread Embedding Acupuncture on Pain Score, Neck Disability Index, and Pressure Pain Threshold for Myofascial Pain Therapy in the Upper Trapezius Muscle
- ClinicalTrials.gov ID
- NCT05987683
- Acronym / sponsor ID
- 23060907
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 14 Aug 2023 (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.
Myofascial pain is characterized by myofascial trigger points, considered as a major cause of neck and shoulder pain in the working population. Thread-embedding acupuncture is a new acupuncture modality that can provide long-term stimulation aimed at prolonging its therapeutic effect that is similar to conventional acupuncture, such as analgesic effects. The goal of this randomized controlled trial is to evaluate and compare the effects of thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the upper trapezius muscle. The primary aim of this study is to investigate whether thread-embedding acupuncture therapy gives better and last longer results for myofascial pain of the upper trapezius muscle than sham thread-embedding acupuncture.
Detailed description
This is a clinical trial study to evaluate and compare the effects of thread-embedding acupuncture and sham thread-embedding acupuncture as a therapy for myofascial pain in the upper trapezius muscle. The subjects are 44 males/female with myofascial pain in the upper trapezius muscle and will be randomly assigned to 2 groups: (1) thread-embedding acupuncture and (2) Sham thread-embedding acupuncture. The subjects will receive a single treatment. The outcome will be assessed before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment. Patients and the outcome assessors will be blinded to the group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thread-Embedding Acupuncture | Experimental | Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding AcupunctureThread-Embedding Acupuncture using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread |
| Sham Thread-Embedding Acupuncture | Sham comparator | Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding AcupunctureSham Thread-Embedding Acupuncture using a 29-gauge TEA needle but thread-removed, just needle alone |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female aged 18-59 years.
- Subject with myofascial pain in the upper trapezius muscle.
- VAS score of 30-70 mm from 100 mm during activities (everyday activities or light exercise).
- Pain > 3 months.
- Willing to participate in this research to completion and sign informed consent.
Key exclusion criteria (14 listed)
- Fibromyalgia.
- Have had cervical spine surgery.
- Have done Dry needling therapy on the upper trapezius muscle in the last 9 days
- Have done thread acupuncture on the upper trapezius muscle in the last 6 months.
- Have performed pharmacopuncture on the upper trapezius muscle in the last 6 months.
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 |
|---|---|---|
| Thread-Embedding Acupuncture, Sham Thread-Embedding AcupunctureThread-Embedding Acupuncture: using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread Sham Thread-Embedding Acupuncture: using a 29-gauge TEA needle but thread-removed, just needle alone | Procedure or surgery | Sham Thread-Embedding Acupuncture, Thread-Embedding Acupuncture |
Primary outcome
Visual Analog Scale
Time frame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
Pain rating scale for measuring pain
2 secondary outcomes
Neck Disability Index
Time frame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
Pressure Pain Threshold
Time frame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
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 27 Dec 2023.
- Individual participant dataSharing planned: Yes
Related trials for Myofascial Pain of Upper Trapezius Muscle
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The Immediate Effects of Dry Needling Acupuncture on Pain Intensity and Pressure Pain Threshold in Patients With Myofascial Pain Syndrome of the Upper Trapezius
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Comparison of Suboccipital Release and Muscle Energy Technique in Subjects With Mechanical Neck Pain and Forward Head Posture
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Comparison of Ischemic Release and Sustained Pressure Direct Myofascial Release in Upper Trapezius Trigger Point
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Kinesio Taping for Upper Trapezius Myofascial Trigger Points
Myofascial Pain Syndromes, Myofascial Trigger Point Pain
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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.
KEPK FKUI-RSCM principal investigator
The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Myofascial Pain of Upper Trapezius Muscle, run by Universitas Indonesia at 2 sites in Indonesia.
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 5 inclusion and 14 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 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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?
Visual Analog Scale (time frame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment). 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 27 Dec 2023.