Clinical trial NCT05637047: Pulsed Radiofrequency vs Dry Needling in Myofascial Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Pain
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain VAS score
timeFrame: Postoperative six months
Secondary outcomes:
measure: Pain VAS score
timeFrame: postoperaitve day 0 and postoperative 1 and 3 months
measure: NDI
timeFrame: postoperaitve day 0 and postoperative 1, 3 and 6 months
measure: PHQ9
timeFrame: postoperaitve day 0 and postoperative 1, 3 and 6 months
measure: GAD7
timeFrame: postoperaitve day 0 and postoperative 1, 3 and 6 months
measure: Sleep status
timeFrame: postoperaitve day 0 and postoperative 1, 3 and 6 months
measure: SF36
timeFrame: postoperaitve day 0 and postoperative 1, 3 and 6 months
measure: Mechanical pain threshold
timeFrame: postoperaitve day 0 and postoperative 1, 3 and 6 months
Other outcomes:
Locations:
Study officials:
References: