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Not yet recruitingNCT05637047Updated May 6, 2023

Pulsed Radiofrequency vs Dry Needling in Myofascial Pain

An interventional study of pulsed radiofrequency and Dry needling in Myofascial Pain, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myofascial Pain
03

In context

Myofascial Pain Syndromes

1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.

This study's planned enrollment of 108 is above the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.

Browse Myofascial Pain Syndromes studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    pulsed radiofrequency

    Procedure: pulsed radiofrequency

  • Active comparator
    Dry needling

    Procedure: Dry needling

Interventions

  • Procedurepulsed radiofrequency

    ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation

  • ProcedureDry needling

    ultrasound-guided intramuscular and interfascial dry needling

06

What researchers measure

Primary outcomes

  1. Pain VAS score

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

    Time frame: Postoperative six months

Secondary outcomes

  1. Pain VAS score

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

    Time frame: postoperaitve day 0 and postoperative 1 and 3 months

  2. NDI

    Neck disability index

    Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months

  3. PHQ9

    patient health questionnaire

    Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months

  4. GAD7

    generalized anxiety disorder (GAD-7) scale

    Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months

  5. Sleep status

    Likert scale 1 to 5, 1 indicates very bad, 5 indicates very good

    Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months

  6. SF36

    health related quality of life short form 36 scale

    Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months

  7. 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.

    Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05637047
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Jin Wang (Doctor, Peking Union Medical College Hospital) — Principal investigator
First posted
Dec 5, 2022
Start date
Sep 1, 2023 (estimated)
Primary completion
Sep 1, 2024 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
May 6, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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