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 Identifier: NCT05987683
• Recruitment Status: Completed
• First Posted: August 14, 2023
• Last Update Posted: December 27, 2023
• Sponsor: Indonesia University
• Information provided by (Responsible Party): Emilia Puspitasari Winarno, Indonesia University

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Myofascial Pain of Upper Trapezius Muscle	Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 21, 2023
• Actual Primary Completion Date: October 31, 2023
• Actual Study Completion Date: October 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Thread-Embedding Acupuncture; Thread-Embedding Acupuncture using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread	Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture; 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
Sham Comparator: Sham Thread-Embedding Acupuncture; Sham Thread-Embedding Acupuncture using a 29-gauge TEA needle but thread-removed, just needle alone	Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture; 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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Neck Disability Index [ Time Frame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment ]
   A questionnaire for measuring self-rated disability due to neck pain
2. Pressure Pain Threshold [ Time Frame: before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment ]
   Using the minimum force applied which induces pain, measured with algometer

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Indonesia

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia, 10430

Persahabatan Hospital

Jakarta, DKI Jakarta, Indonesia, 13230

Sponsors and Collaborators

Indonesia University

Investigators

• Principal Investigator: KEPK FKUI-RSCM; The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

More Information

• Responsible Party: Emilia Puspitasari Winarno, Doctor, Indonesia University
• ClinicalTrials.gov Identifier: NCT05987683
• Other Study ID Numbers: 23060907
• First Posted: August 14, 2023
• Last Update Posted: December 27, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases