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The Effectiveness of Thread-Embedding Acupuncture as Therapy for Myofascial Pain in the Upper Trapezius Muscle

Primary Purpose

Myofascial Pain of Upper Trapezius Muscle

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain of Upper Trapezius Muscle

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cipto Mangunkusumo HospitalRecruiting
  • Persahabatan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Thread-Embedding Acupuncture

Sham Thread-Embedding Acupuncture

Arm Description

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

Outcomes

Primary Outcome Measures

Visual Analog Scale
Pain rating scale for measuring pain

Secondary Outcome Measures

Neck Disability Index
A questionnaire for measuring self-rated disability due to neck pain
Pressure Pain Threshold
Using the minimum force applied which induces pain, measured with algometer

Full Information

First Posted
July 26, 2023
Last Updated
September 2, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05987683
Brief Title
The Effectiveness of Thread-Embedding Acupuncture as Therapy for Myofascial Pain in the Upper Trapezius Muscle
Official Title
The Effectiveness of Thread-Embedding Acupuncture as Therapy for Myofascial Pain in the Upper Trapezius Muscle
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain of Upper Trapezius Muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thread-Embedding Acupuncture
Arm Type
Experimental
Arm Description
Thread-Embedding Acupuncture using a 29-gauge TEA needle with a 50-mm PDO (polydioxanone) thread
Arm Title
Sham Thread-Embedding Acupuncture
Arm Type
Sham Comparator
Arm Description
Sham Thread-Embedding Acupuncture using a 29-gauge TEA needle but thread-removed, just needle alone
Intervention Type
Procedure
Intervention Name(s)
Thread-Embedding Acupuncture, Sham Thread-Embedding Acupuncture
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Pain rating scale for measuring pain
Time Frame
before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
A questionnaire for measuring self-rated disability due to neck pain
Time Frame
before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment
Title
Pressure Pain Threshold
Description
Using the minimum force applied which induces pain, measured with algometer
Time Frame
before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilia P Winarno, Doctor
Phone
+628122018588
Email
lia_pw@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KEPK FKUI-RSCM
Organizational Affiliation
The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cipto Mangunkusumo, Hospital
Phone
1 500 135
Facility Name
Persahabatan Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
13230
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Persahabatan, Hospital
Phone
(021) 4891708

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The Effectiveness of Thread-Embedding Acupuncture as Therapy for Myofascial Pain in the Upper Trapezius Muscle

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