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

NCT ID: NCT05987683

Last Updated: 2023-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2023-10-31

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.

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.

Conditions

Myofascial Pain of Upper Trapezius Muscle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Thread-Embedding Acupuncture

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

Group Type: EXPERIMENTAL

Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture

Intervention Type: 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

Sham Thread-Embedding Acupuncture using a 29-gauge TEA needle but thread-removed, just needle alone

Group Type: SHAM_COMPARATOR

Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Emilia Puspitasari Winarno

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KEPK FKUI-RSCM

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

Persahabatan Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

23060907

Identifier Type: -

Identifier Source: org_study_id