Efficacy of Focused ESWT and Dry Needling Among Patients With Myofascial Pain Syndrome of the Upper Trapezius Muscle

February 6, 2026 updated by: Mahidol University

The Comparative Efficacy of Focused Extracorporeal Shockwave Therapy and Dry Needling Among Patients With Myofascial Pain Syndrome of the Upper Trapezius Muscle, a Randomized Controlled Trial.

Myofascial pain syndrome (MPS) is one of the most common causes of musculoskeletal pain. Among patients with MPS, the upper trapezius muscle appears to be the common muscle that generates pain in the area of upper extremity. The main target treatment for MPS is to eradicate the painful trigger points by using treatment options, such as ultrasound, laser, and dry needling (DN). In the past decade, focused extracorporeal shockwave therapy (fESWT) has become the well-known treatment for pain relief in various musculoskeletal pain conditions. The main advantages of this non-invasive treatment modality are reducing pain, inflammation and promoting tissue healing. However, there were no previous studies compared effects of fESWT to dry needling. Therefore, the present study aims to compare the efficacy of the two treatments in terms of pain reduction and functional improvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • This study is a single-blinded non-inferiority randomized controlled trial that will compare the efficacy of fESWT to DN in terms of pain reduction and functional improvement in patients with MPS of the upper trapezius.
  • 58 patients will be recruited for the study and randomly allocated to 2 groups, mainly fESWT and DN.
  • For the fESWT group, the participants will receive fESWT once a week, for a total of 3 sessions, consecutively. While the participants in the DN group will receive DN at the painful trigger point for 1 session. Moreover, both groups will receive the same conservative treatment, for example, education, exercise, and behavioral modification advice.
  • The primary outcome is Visual Analogue Scale (VAS) and the secondary outcomes are Pain Pressure Threshold (PPT) and Neck Disability Index (NDI) which will be recorded at baseline, 1 week, 3 week, and 6 week from baseline.
  • Statistical analysis will be performed using Stata to detect statistically significant changes in the same group and differences between the two groups.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The participant who is diagnosed with myofascial pain syndrome based on the criteria listed below:

The trigger point must be in a taut band of the upper trapezius muscle. The trigger point in the muscle is hypersensitivity to pain. Pain radiates to the specific pattern of the upper trapezius muscle. When pressure is applied to the trigger point, the participant perceives the same pain sensation as their pain complaint.

  • The participant who has a VAS score of > or = 5 points
  • The participant who has had myofascial pain for > or = 3 months

Exclusion Criteria: The participant who has

  • Unresolved neurological or musculoskeletal problems, such as fibromyalgia, cervical radiculopathy, and cervical spine fracture.
  • History of cervical spine or shoulder surgery
  • Uncontrolled underlying diseases, such as psychological problems, cancer, or acute renal or hepatic failure
  • Received treatment by other physical modalities or steroid injection into the trigger point within 3 months, or was treated by analgesic drugs within 2 weeks.
  • Contraindicated to ESWT or DN
  • Refuse to attend the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Focused Extracorporeal Shockwave Therapy (fESWT)
The participant will be treated by fESWT plus conservative treatment. fESWT will be applied once a week, for a total of 3 sessions.
Device: Focused Extracorporeal Shockwave Therapy (fESWT)
fESWT will be done using an energy flux density of 0.20 - 0.25 millijoule (mJ)/mm2, a frequency of 4 Hz, and 1000 shocks per session which will be done one session per week, for a total of 3 sessions, consecutively.
Active Comparator: Dry needling (DN)
The participant will be treated by DN plus conservative treatment. DN will be done as a single session.
Other: Dry needling (DN)

DN will be done by using a sterile technique with a sterile acupuncture needle, a diameter of 0.25 mm, and a length of 30-40 mm.

The needle will be applied to the painful active trigger point using fan-shaped movements and the fast-in and fast-out technique until the twitching response disappears.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: Changes in VAS were assessed at baseline, and at 4 and 6 weeks following baseline.
VAS is a subjective tool that is used to measure pain scores. In this study, the 100-numerical scale will be used, in which 0 means "no pain," whereas 100 means "the worst pain." Patients mark the scale to rate the pain score based on their pain perception.
Changes in VAS were assessed at baseline, and at 4 and 6 weeks following baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain pressure threshold (PPT)
Time Frame: Changes in PPT were assessed at baseline, and at 4 and 6 weeks following baseline.
PPT is used to assess the strength of a physical stimulus that causes pain. A mechanical pressure is applied over the measured area, such as a muscle. The minimum force that provokes pain is determined as the pain threshold.
Changes in PPT were assessed at baseline, and at 4 and 6 weeks following baseline.
The Neck Disability Index (NDI)
Time Frame: Changes in NDI were assessed at baseline and 6 weeks following baseline.
The Neck Disability Index (NDI) is a self-report questionnaire intended to evaluate patients' disabilities and how much their neck pain impacts their lives. This questionnaire consists of 10 items; 5 points for each item (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation).
Changes in NDI were assessed at baseline and 6 weeks following baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Thitiporn Phakdepiboon, MD, Ramathibodi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MURA2022/525

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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