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Pulsed Radiofrequency vs Dry Needling in Myofascial Pain

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05637047
Enrollment
108
Registered
2022-12-05
Start date
2023-09-01
Completion date
2025-06-01
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain

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.

Interventions

PROCEDUREpulsed radiofrequency

ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation

PROCEDUREDry needling

ultrasound-guided intramuscular and interfascial dry needling

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain VAS scorePostoperative six monthsPain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.

Secondary

MeasureTime frameDescription
PHQ9postoperaitve day 0 and postoperative 1, 3 and 6 monthspatient health questionnaire
Pain VAS scorepostoperaitve day 0 and postoperative 1 and 3 monthsPain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.
GAD7postoperaitve day 0 and postoperative 1, 3 and 6 monthsgeneralized anxiety disorder (GAD-7) scale
NDIpostoperaitve day 0 and postoperative 1, 3 and 6 monthsNeck disability index
SF36postoperaitve day 0 and postoperative 1, 3 and 6 monthshealth related quality of life short form 36 scale
Mechanical pain thresholdpostoperaitve day 0 and postoperative 1, 3 and 6 monthsMechanical pain threshold will be tested by pressing the pain point with an ergometer for three times and calculated the mean value of the pressure.
Sleep statuspostoperaitve day 0 and postoperative 1, 3 and 6 monthsLikert scale 1 to 5, 1 indicates very bad, 5 indicates very good

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026