COMPARISON OF THREE TREATMENT MODALITIES IN MYOFASCIAL PAIN SYNDROME (MPS-TREAT)

May 1, 2026 updated by: ALİEMAN

COMPARATIVE EFFECTIVENESS OFF DRY NEEDLING, EXTRACORPOREAL SHOCK WAVE THERAPY, AND TRANSCUTANEOUS PULSED RADIOFREQUENCY IN PATIENTS WITH MYOFASCIAL PAIN SYNDROME: A PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL

This study aims to compare the effectiveness of dry needling, extracorporeal shock wave therapy (ESWT), and pulsed radiofrequency (PRF) in patients with chronic musculoskeletal pain. The primary outcomes include pain intensity and functional status. Patients will be randomly assigned to different treatment groups, and outcomes will be evaluated before and after the interventions. The results of this study are expected to contribute to determining the most effective treatment method for pain management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Myofascial pain syndrome is a common musculoskeletal disorder characterized by trigger points and chronic pain. Various treatment modalities such as dry needling, extracorporeal shock wave therapy (ESWT), and pulsed radiofrequency (PRF) are used in clinical practice; however, there is no clear consensus on the most effective approach.

This randomized, parallel-group study aims to compare the effectiveness of these three treatment methods in patients diagnosed with myofascial pain syndrome. Eligible patients aged between 18 and 65 years with chronic back pain lasting at least 3 months will be included in the study. Participants will be randomly assigned to receive dry needling, ESWT, or PRF treatment.

Pain intensity will be assessed using the Numeric Rating Scale (NRS), and functional outcomes will also be evaluated. The study is expected to contribute to the current literature by providing comparative data on these commonly used treatment modalities and guiding clinical decision-making.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

Study Locations

  • Turkey (Türkiye)
    • Sakarya
      • Adapazarı, Sakarya, Turkey (Türkiye)
        • Recruiting
        • Sakarya Training and Research 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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 65 years
  • Clinically diagnosed myofascial pain syndrome
  • Back pain lasting at least 3 months
  • Failure to respond to conservative treatments

Exclusion Criteria:

  • History of cervical surgery or cervical disc pathology
  • Fibromyalgia
  • Shoulder pathologies
  • Coagulation disorders or use of anticoagulant therapy
  • Infection, malignancy, or inflammatory spinal diseases

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry Needling Group
Patients receiving dry needling treatment.
Procedure: Dry Needling
Dry needling applied to myofascial trigger points
Experimental: ESWT Group
Patients receiving extracorporeal shock wave therapy (ESWT)
Procedure: Extracorporeal Shock Wave Therapy
Extracorporeal shock wave therapy applied to the painful area
Experimental: PRF Group
Patients receiving pulsed radiofrequency (PRF) treatment.
Procedure: Pulsed radiofrequency(PRF)
Pulsed radiofrequency applied to the target area for the treatment of myofascial pain syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline, 1 month, and 3 months after treatment
Pain intensity will be assessed using the Numeric Rating Scale(NRS). Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain severity.
Baseline, 1 month, and 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Pain Threshold
Time Frame: Baseline, 1 month, and 3 months after treatment
Pressure pain threshold will be measured using algometry. Pressure pain threshold will be measured using an algometer (kg/cm²). Higher values indicate lower pain sensitivity and improved clinical condition.
Baseline, 1 month, and 3 months after treatment
Neck Disability Index (NDI)
Time Frame: Baseline, 1 month, and 3 months after treatment
Functional status will be evaluated using the Neck Disability Index (NDI). Functional status will be assessed using the Neck Disability Index (NDI), with scores ranging from 0 to 50. Higher scores indicate greater functional impairment.
Baseline, 1 month, and 3 months after treatment
Quality of Life (SF-12
Time Frame: Baseline, 1 month, and 3 months after treatment
Quality of life will be assessed using the Short Form-12 (SF-12) questionnaire. The SF-12 includes physical and mental component summary scores, with higher scores indicating better health-related quality of life.
Baseline, 1 month, and 3 months after treatment

Collaborators and Investigators

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

Sponsor

ALİEMAN

Investigators

  • Principal Investigator: KEMAL NAS, MD, Professor, Sakarya University Training and Research Hospital, Department of Algology
  • Study Chair: RIDVAN ISIK, MD, Sakarya University Training and Research Hospital, Department of Algology

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)

March 10, 2026

Primary Completion (Estimated)

March 10, 2027

Study Completion (Estimated)

March 10, 2027

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAS-TEZ--2026

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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