Pulsed Radiofrequency vs Dry Needling in Myofascial Pain

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05637047

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myofascial Pain	Procedure: pulsed radiofrequency Procedure: Dry needling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Ultrasound-guided Pulsed Radiofrequency Ablation Versus Dry Needling in the Treatment of Myofascial Pain: a Randomized Controlled Trial

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pulsed radiofrequency	Procedure: pulsed radiofrequency ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation
Active Comparator: Dry needling	Procedure: Dry needling ultrasound-guided intramuscular and interfascial dry needling

Arm

Intervention/Treatment

Experimental: pulsed radiofrequency

Procedure: pulsed radiofrequency

ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation

Active Comparator: Dry needling

Procedure: Dry needling

ultrasound-guided intramuscular and interfascial dry needling

Outcome Measures

Primary Outcome Measures

Pain VAS score [Postoperative six months]
Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.

Secondary Outcome Measures

Pain VAS score [postoperaitve day 0 and postoperative 1 and 3 months]
Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.
NDI [postoperaitve day 0 and postoperative 1, 3 and 6 months]
Neck disability index
PHQ9 [postoperaitve day 0 and postoperative 1, 3 and 6 months]
patient health questionnaire
GAD7 [postoperaitve day 0 and postoperative 1, 3 and 6 months]
generalized anxiety disorder (GAD-7) scale
Sleep status [postoperaitve day 0 and postoperative 1, 3 and 6 months]
Likert scale 1 to 5, 1 indicates very bad, 5 indicates very good
SF36 [postoperaitve day 0 and postoperative 1, 3 and 6 months]
health related quality of life short form 36 scale
Mechanical pain threshold [postoperaitve day 0 and postoperative 1, 3 and 6 months]
Mechanical pain threshold will be tested by pressing the pain point with an ergometer for three times and calculated the mean value of the pressure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronic myofascial pain (>3 months) at the neck, shoulder and upper back region
Have at least score of "moderate" on the pain VAS, thus a minimal clinically significant change is detectable

Exclusion Criteria:

Currently undergoing other pain related treatment (acupuncture, laser, infrared therapy. etc)
Presence or history of trauma, surgery or infection in the pain region.
Severe systemic disease (severe hepatic or renal dysfunction), coagulopathy or on medications affecting coagulation system.
Allergic to medications used.
Pregnant, medical background, unable to cooperate or refused to participate.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin Wang, Doctor, Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT05637047

Other Study ID Numbers:

PRFversusDN

First Posted:

Dec 5, 2022

Last Update Posted:

Dec 20, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myofascial Pain Syndromes

Study Results

No Results Posted as of Dec 20, 2022