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

NCT05987683 | Completed

• 1 other identifier: 23060907
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Myofascial Pain of Upper Trapezius Muscle

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  Pain rating scale for measuring pain

  before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment

Secondary Outcomes (2)

• Neck Disability Index

  before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment

• Pressure Pain Threshold

  before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment

Study Arms (2)

Thread-Embedding Acupuncture

EXPERIMENTAL

Thread-Embedding Acupuncture using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread

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

Procedure: Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture

Interventions

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

Sham Thread-Embedding Acupuncture; Thread-Embedding Acupuncture

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (2)

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Persahabatan Hospital

Jakarta, DKI Jakarta, 13230, Indonesia

Location

Study Officials

• KEPK FKUI-RSCM

  The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: August 21, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ID (2)