NCT05637047

Brief Summary

Myofascial pain (MPS) is the leading cause of chronic and persistent regional pain, affecting as many as 85% of the general population. A variety of treatment methods for myofascial pain have been investigated, including injection of saline, local anesthetics and steroids, dry needle, mini-scalpel, rich platelet plasma and radiofrequency ablation. Ultrasound guided dry needle (DN) and pulsed radiofrequency ablation (PRF) of the trigger point have been considered as two effective and promising treatments for myofascial pain. As far as searched, we failed to identify any study comparing the effects of DN and PRF in 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
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

November 27, 2022

Last Update Submit

May 3, 2023

Conditions

Myofascial Pain

Outcome Measures

Primary Outcomes (1)

  • Pain VAS score

    Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.

    Postoperative six months

Secondary Outcomes (7)

  • Pain VAS score

    postoperaitve day 0 and postoperative 1 and 3 months

  • NDI

    postoperaitve day 0 and postoperative 1, 3 and 6 months

  • PHQ9

    postoperaitve day 0 and postoperative 1, 3 and 6 months

  • GAD7

    postoperaitve day 0 and postoperative 1, 3 and 6 months

  • Sleep status

    postoperaitve day 0 and postoperative 1, 3 and 6 months

  • +2 more secondary outcomes

Study Arms (2)

pulsed radiofrequency

EXPERIMENTAL
Procedure: pulsed radiofrequency

Dry needling

ACTIVE COMPARATOR
Procedure: Dry needling

Interventions

pulsed radiofrequencyPROCEDURE

ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation

pulsed radiofrequency
Dry needlingPROCEDURE

ultrasound-guided intramuscular and interfascial dry needling

Dry needling

Eligibility Criteria

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

You may qualify if:

  • Aged between 18 and 70 years old.
  • Chronic (\>3 months) myofascial pain in the neck, shoulder, and upper back region.
  • Myofascial pain will be diagnosed based on Simons and Travell's criteria: taut band palpable, exquisite spot tenderness of a nodule in a taut band, patient's recognition of current pain complaint by pressure on the tender nodule, and painful limit to full stretch range of motion.
  • Have at least a pain VAS score of 40 mm; thus, a minimal clinically significant change is detectable.

You may not qualify if:

  • History of receiving DN or PRF treatment or currently undergoing other pain-related treatments (acupuncture, laser, infrared therapy, etc.).
  • Presence or history of trauma, surgery, or infection in the pain region.
  • Current or history of taking moderate to strong analgesics, such as tramadol and morphine.
  • Severe systemic disease (eg. severe hepatic or renal dysfunction), coagulopathy, or medications affecting the coagulation system.
  • Allergy to medications used.
  • Pregnancy, psychiatric disease, medical background, inability to cooperate, or refusal to participate.
  • Withdrawn Criteria:
  • Unwilling to continue participation or unable to follow the treatment plan.
  • Unable to obtain the primary outcome data due to any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wang J, Zhang Y, Cui X, Shen L. Ultrasound-guided pulsed radiofrequency versus dry needling for pain management in chronic neck and shoulder myofascial pain syndrome patients at a tertiary hospital in China: a randomised controlled trial protocol. BMJ Open. 2023 May 24;13(5):e071422. doi: 10.1136/bmjopen-2022-071422.

    PMID: 37225266DERIVED

MeSH Terms

Interventions

Pulsed Radiofrequency TreatmentDry Needling

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRadiofrequency TherapyRehabilitationComplementary Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 27, 2022

First Posted

December 5, 2022

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

June 1, 2025

Last Updated

May 6, 2023

Record last verified: 2023-05