Pulsed Radiofrequency vs Dry Needling in Myofascial Pain

Myofascial Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05637047
• Other study ID #: PRFversusDN
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: June 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myofascial Pain
• Myofascial Pain Syndromes

Intervention

Procedure:
• pulsed radiofrequency
ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation
• Dry needling
ultrasound-guided intramuscular and interfascial dry needling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain VAS score	Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.	Postoperative six months
Secondary	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
Secondary	NDI	Neck disability index	postoperaitve day 0 and postoperative 1, 3 and 6 months
Secondary	PHQ9	patient health questionnaire	postoperaitve day 0 and postoperative 1, 3 and 6 months
Secondary	GAD7	generalized anxiety disorder (GAD-7) scale	postoperaitve day 0 and postoperative 1, 3 and 6 months
Secondary	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
Secondary	SF36	health related quality of life short form 36 scale	postoperaitve day 0 and postoperative 1, 3 and 6 months
Secondary	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