Myofascial PainNCT06851000
The Effects of Ultrasound-guided PRF Versus DN in Myofascial Pain Patients
A study testing ultrasound-guided pulsed radiofrequency and ultrasound-guided dry needling in people with Myofascial Pain, run by Peking Union Medical College Hospital.
Trial summary
This study aims to compare the effects of pulsed radiofrequency and drying needling and explore the short-term effect of pulsed radiofrequency in treating myofascial pain patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myofascial Pain
- What is being tested?
- ultrasound-guided pulsed radiofrequency and ultrasound-guided dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2025to 25 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old, gender unlimited.
- Myofascial pain diagnosed according to the "Simons and Travell" criteria.
- Able to complete treatment and follow-up.
- Signed inform consent form.
Who cannot join
- History of surgery, trauma, or infection in the pain area.
- Severe systemic disease, e.g. malignant tumor; severe hepatic, renal, or coagulation disorder; etc.
- Pregnancy, needle phobia, unable to cooperate.
- Concurrently receiving pain treatment in other institutions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of Ultrasound-guided Pulsed Radiofrequemcy Versus Dry Needling in Myofascial Pain Patients
This study aims to compare the effects of pulsed radiofrequency and drying needling and explore the short-term effect of pulsed radiofrequency in treating myofascial pain patients.
- Conditions
- Myofascial Pain
- Being tested
- ultrasound-guided pulsed radiofrequency, ultrasound-guided dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided pulsed radiofrequencyProcedure or surgery
Medication: 0-3months; Pulsed radiofrequency: week 2, 6, 10;
ultrasound-guided dry needlingProcedure or surgery
Medication: 0-3 months; Dry needling: week 2; Pulsed radiofrequency: week 6, 10;
| Study group | Role | What they receive |
|---|---|---|
| PRF-PRF | Experimental | Not described Receives: Procedure: ultrasound-guided pulsed radiofrequency |
| DN-PRF | Active comparator | Not described Receives: Procedure: ultrasound-guided dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mechanical pain threshold (△MPT)
Mechanical pain threshold was measured by an ergometer called Microfet3. △MPT=MPT4wk (MPT measured at week 4)-MPT 2wk (MPT measured at week 2).
Measured: week 0 to week 4
Secondary outcomes (4)
Severity of pain
Pain was measured by a numerical rating scale (NRS), with 0 symbolizing no pain and 10 symbolizing the worst pain one could imagine.
Measured: week 0 to week 12
Sleep
The quality of sleep was measured by Athens Insomnia Scale.
Measured: week 0 to week 12
Depression and anxiety
Depression was measured by Patient Health Questionnaire-9. Anxiety was measured by a Generalized Anxiety Disorder-7 item scale.
Measured: week 0 to week 12
Life quality
The quality of life was measured by Short Form 36 Health Survey.
Measured: week 0 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start25 Feb 2025 (estimated)
- Primary completion25 Nov 2025 (estimated)
- Study completion25 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Xulei, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06851000
- Sponsor's protocol ID
- PRF-DN
- Status last verified
- Mar 2025
- First submitted
- 13 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ultrasound-guided Pulsed Radiofrequemcy Versus Dry Needling in Myofascial Pain Patients
- ClinicalTrials.gov ID
- NCT06851000
- Acronym / sponsor ID
- PRF-DN
- Conditions
- Myofascial Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 25 Feb 2025 (estimated)
- Primary completion
- 25 Nov 2025 (estimated)
- Study completion
- 25 Mar 2026 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effects of pulsed radiofrequency and drying needling and explore the short-term effect of pulsed radiofrequency in treating myofascial pain patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF-PRF | Experimental | Procedure: ultrasound-guided pulsed radiofrequency |
| DN-PRF | Active comparator | Procedure: ultrasound-guided dry needling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years old, gender unlimited.
- Myofascial pain diagnosed according to the "Simons and Travell" criteria.
- Able to complete treatment and follow-up.
- Signed inform consent form.
Key exclusion criteria (4 listed)
- History of surgery, trauma, or infection in the pain area.
- Severe systemic disease, e.g. malignant tumor; severe hepatic, renal, or coagulation disorder; etc.
- Pregnancy, needle phobia, unable to cooperate.
- Concurrently receiving pain treatment in other institutions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided pulsed radiofrequencyMedication: 0-3months; Pulsed radiofrequency: week 2, 6, 10; | Procedure or surgery | PRF-PRF |
| ultrasound-guided dry needlingMedication: 0-3 months; Dry needling: week 2; Pulsed radiofrequency: week 6, 10; | Procedure or surgery | DN-PRF |
Primary outcome
Change of mechanical pain threshold (△MPT)
Time frame: week 0 to week 4
Mechanical pain threshold was measured by an ergometer called Microfet3. △MPT=MPT4wk (MPT measured at week 4)-MPT 2wk (MPT measured at week 2).
4 secondary outcomes
Severity of pain
Time frame: week 0 to week 12
Sleep
Time frame: week 0 to week 12
Depression and anxiety
Time frame: week 0 to week 12
Life quality
Time frame: week 0 to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided pulsed radiofrequency and ultrasound-guided dry needling in people with Myofascial Pain, run by Peking Union Medical College Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin Wang (+86 15210424157, wangjin05@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mechanical pain threshold (△MPT) (time frame: week 0 to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.