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

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain of Upper Trapezius Muscle
• Intervention / Treatment: Procedure: Thread-Embedding Acupuncture, 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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilia P Winarno, Doctor; Phone Number: +628122018588; Email: lia_pw@yahoo.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Hospital
    • Jakarta, DKI Jakarta, Indonesia, 13230
      • Persahabatan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Myofascial Pain Syndromes
• Other Study ID Numbers: 23060907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No