Ultrasound-guided Pulsed Radiofrequency Versus Dry Needling for Pain Management in Chronic Neck and Shoulder Myofascial Pain Patients at a Tertiary Hospital in China: A Randomized Controlled Trial

Peking Union Medical College Hospital0 sites108 target enrollmentSeptember 1, 2023

ConditionsMyofascial Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Myofascial Pain
Sponsor: Peking Union Medical College Hospital
Enrollment: 108
Primary Endpoint: Pain VAS score
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2023

End Date

June 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Principal Investigator

Jin Wang

Doctor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

Pain VAS score

Time Frame: Postoperative six months

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

Secondary Outcomes

Pain VAS score(postoperaitve day 0 and postoperative 1 and 3 months)
Sleep status(postoperaitve day 0 and postoperative 1, 3 and 6 months)
PHQ9(postoperaitve day 0 and postoperative 1, 3 and 6 months)
NDI(postoperaitve day 0 and postoperative 1, 3 and 6 months)
GAD7(postoperaitve day 0 and postoperative 1, 3 and 6 months)
SF36(postoperaitve day 0 and postoperative 1, 3 and 6 months)
Mechanical pain threshold(postoperaitve day 0 and postoperative 1, 3 and 6 months)