The Effects of Ultrasound-guided PRF Versus DN in Myofascial Pain Patients

March 4, 2025 updated by: Cui Xulei, Peking Union Medical College Hospital

The Effects of Ultrasound-guided Pulsed Radiofrequemcy Versus Dry Needling in Myofascial Pain Patients

This study aims to compare the effects of pulsed radiofrequency and drying needling and explore the short-term effect of pulsed radiofrequency in treating myofascial pain patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

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

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 18-70 years old, gender unlimited.
  • Myofascial pain diagnosed according to the "Simons and Travell" criteria.
  • Able to complete treatment and follow-up.
  • Signed inform consent form.

Exclusion Criteria:

  • History of surgery, trauma, or infection in the pain area.
  • Severe systemic disease, e.g. malignant tumor; severe hepatic, renal, or coagulation disorder; etc.
  • Pregnancy, needle phobia, unable to cooperate.
  • Concurrently receiving pain treatment in other institutions.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRF-PRF
Procedure: ultrasound-guided pulsed radiofrequency
Medication: 0-3months; Pulsed radiofrequency: week 2, 6, 10;
Active Comparator: DN-PRF
Procedure: ultrasound-guided dry needling
Medication: 0-3 months; Dry needling: week 2; Pulsed radiofrequency: week 6, 10;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of mechanical pain threshold (△MPT)
Time Frame: week 0 to week 4
Mechanical pain threshold was measured by an ergometer called Microfet3. △MPT=MPT4wk (MPT measured at week 4)-MPT 2wk (MPT measured at week 2).
week 0 to week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of pain
Time Frame: week 0 to week 12
Pain was measured by a numerical rating scale (NRS), with 0 symbolizing no pain and 10 symbolizing the worst pain one could imagine.
week 0 to week 12
Sleep
Time Frame: week 0 to week 12
The quality of sleep was measured by Athens Insomnia Scale.
week 0 to week 12
Depression and anxiety
Time Frame: week 0 to week 12
Depression was measured by Patient Health Questionnaire-9. Anxiety was measured by a Generalized Anxiety Disorder-7 item scale.
week 0 to week 12
Life quality
Time Frame: week 0 to week 12
The quality of life was measured by Short Form 36 Health Survey.
week 0 to week 12

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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 (Estimated)

February 25, 2025

Primary Completion (Estimated)

November 25, 2025

Study Completion (Estimated)

March 25, 2026

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRF-DN

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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