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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Myofascial Pain of Upper Trapezius Muscle

Intervention / Treatment
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* Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thread-Embedding Acupuncture<br>Thread-Embedding Acupuncture using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread | Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture<br>* 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<br>|
| Sham Comparator: Sham Thread-Embedding Acupuncture<br>Sham Thread-Embedding Acupuncture using a 29-gauge TEA needle but thread-removed, just needle alone | Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |