Pulsed Radiofrequency vs Dry Needling in Myofascial Pain

NCT ID: NCT05637047

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-06-01

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.

Conditions

Myofascial Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

pulsed radiofrequency

Group Type: EXPERIMENTAL

pulsed radiofrequency

Intervention Type: PROCEDURE

ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation

Dry needling

Group Type: ACTIVE_COMPARATOR

Dry needling

Intervention Type: PROCEDURE

ultrasound-guided intramuscular and interfascial dry needling

Interventions

pulsed radiofrequency

ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation

Intervention Type: PROCEDURE

Dry needling

ultrasound-guided intramuscular and interfascial dry needling

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Wang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 37225266 (View on PubMed)

Other Identifiers

PRFversusDN

Identifier Type: -

Identifier Source: org_study_id