Pulsed Radiofrequency vs Dry Needling in Myofascial Pain

Not Applicable

Not yet recruiting

• Conditions: Myofascial Pain
• Interventions: Procedure: pulsed radiofrequency; Procedure: Dry needling

• Registration Number: NCT05637047
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-27
• Study First Submitted QC: 2022-11-27
• Study First Posted: 2022-12-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06
• Study Start: 2023-09-01
• Primary Completion: 2024-09-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Aged between 18 and 70 years old.
2. Chronic (>3 months) myofascial pain in the neck, shoulder, and upper back region.
3. 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.
4. Have at least a pain VAS score of 40 mm; thus, a minimal clinically significant change is detectable.

Exclusion Criteria

1. History of receiving DN or PRF treatment or currently undergoing other pain-related treatments (acupuncture, laser, infrared therapy, etc.).
2. Presence or history of trauma, surgery, or infection in the pain region.
3. Current or history of taking moderate to strong analgesics, such as tramadol and morphine.
4. Severe systemic disease (eg. severe hepatic or renal dysfunction), coagulopathy, or medications affecting the coagulation system.
5. Allergy to medications used.
6. Pregnancy, psychiatric disease, medical background, inability to cooperate, or refusal to participate.

Withdrawn Criteria:

1. Unwilling to continue participation or unable to follow the treatment plan.
2. Unable to obtain the primary outcome data due to any reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulsed radiofrequency	pulsed radiofrequency	-
Dry needling	Dry needling	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
PHQ9	postoperaitve day 0 and postoperative 1, 3 and 6 months	patient health questionnaire
NDI	postoperaitve day 0 and postoperative 1, 3 and 6 months	Neck disability index
GAD7	postoperaitve day 0 and postoperative 1, 3 and 6 months	generalized anxiety disorder (GAD-7) scale
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.