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Clinical Trials/NCT05987683
NCT05987683
Completed
Not Applicable

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

Indonesia University2 sites in 1 country44 target enrollmentAugust 21, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myofascial Pain of Upper Trapezius Muscle
Sponsor
Indonesia University
Enrollment
44
Locations
2
Primary Endpoint
Visual Analog Scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 21, 2023
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Emilia Puspitasari Winarno

Doctor

Indonesia University

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).

Outcomes

Primary Outcomes

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 Outcomes

  • Pressure Pain Threshold(before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment)
  • Neck Disability Index(before treatment (baseline) and 3 days, 1 week, 4 weeks, 8 weeks after treatment)

Study Sites (2)

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