NCT06851000

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2026

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

February 13, 2025

Last Update Submit

March 4, 2025

Conditions

Myofascial Pain

Outcome Measures

Primary Outcomes (1)

  • Change of mechanical pain threshold (△MPT)

    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 Outcomes (4)

  • Severity of pain

    week 0 to week 12

  • Sleep

    week 0 to week 12

  • Depression and anxiety

    week 0 to week 12

  • Life quality

    week 0 to week 12

Study Arms (2)

PRF-PRF

EXPERIMENTAL
Procedure: ultrasound-guided pulsed radiofrequency

DN-PRF

ACTIVE COMPARATOR
Procedure: ultrasound-guided dry needling

Interventions

ultrasound-guided pulsed radiofrequencyPROCEDURE

Medication: 0-3months; Pulsed radiofrequency: week 2, 6, 10;

PRF-PRF
ultrasound-guided dry needlingPROCEDURE

Medication: 0-3 months; Dry needling: week 2; Pulsed radiofrequency: week 6, 10;

DN-PRF

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Jin Wang

CONTACT

+86 15210424157wangjin05@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 28, 2025

Study Start

February 25, 2025

Primary Completion

November 25, 2025

Study Completion

March 25, 2026

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share