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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thread-Embedding Acupuncture | Experimental | Thread-Embedding Acupuncture using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread |
|
| Sham Thread-Embedding Acupuncture | Sham Comparator | Sham Thread-Embedding Acupuncture using a 29-gauge TEA needle but thread-removed, just needle alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | Pain rating scale for measuring pain | before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index | A questionnaire for measuring self-rated disability due to neck pain | before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment |
| Pressure Pain Threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KEPK FKUI-RSCM | The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Jakarta | DKI Jakarta | 10430 | Indonesia | ||
| Persahabatan Hospital |
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Using the minimum force applied which induces pain, measured with algometer
| before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment |
| Jakarta |
| DKI Jakarta |
| 13230 |
| Indonesia |