Pulsed Radiofrequency vs Dry Needling in Myofascial Pain

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Myofascial Pain

Intervention / Treatment
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* Procedure: pulsed radiofrequency
* Procedure: Dry needling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pulsed radiofrequency<br> | Procedure: pulsed radiofrequency<br>* ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation<br>|
| Active Comparator: Dry needling<br> | Procedure: Dry needling<br>* ultrasound-guided intramuscular and interfascial dry needling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS score | Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable. | Postoperative six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS score | Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable. | postoperaitve day 0 and postoperative 1 and 3 months | 
| NDI | Neck disability index | postoperaitve day 0 and postoperative 1, 3 and 6 months | 
| PHQ9 | patient health questionnaire | postoperaitve day 0 and postoperative 1, 3 and 6 months | 
| GAD7 | generalized anxiety disorder (GAD-7) scale | postoperaitve day 0 and postoperative 1, 3 and 6 months | 
| Sleep status | Likert scale 1 to 5, 1 indicates very bad, 5 indicates very good | postoperaitve day 0 and postoperative 1, 3 and 6 months | 
| SF36 | health related quality of life short form 36 scale | postoperaitve day 0 and postoperative 1, 3 and 6 months | 
| Mechanical pain threshold | 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. | postoperaitve day 0 and postoperative 1, 3 and 6 months |