Skip to main content
OpenTrials
Completed

NCT Number: NCT05987683

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital, Jakarta, DKI Jakarta, Indonesia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Neck Disability Index

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

    A questionnaire for measuring self-rated disability due to neck pain

  2. Pressure Pain Threshold

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

    Using the minimum force applied which induces pain, measured with algometer

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.