Myofascial PainNCT05637047
Pulsed Radiofrequency vs Dry Needling in Myofascial Pain
A study testing pulsed radiofrequency and Dry needling in people with Myofascial Pain, run by Peking Union Medical College Hospital.
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… 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?
- pulsed radiofrequency and Dry needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
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- Withdrawn Criteria:
- Unwilling to continue participation or unable to follow the treatment plan.
- Unable to obtain the primary outcome data due to any reason.
About this study
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
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.
- Conditions
- Myofascial Pain
- Being tested
- pulsed radiofrequency, Dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed radiofrequencyProcedure or surgery
ultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation
Dry needlingProcedure or surgery
ultrasound-guided intramuscular and interfascial dry needling
| Study group | Role | What they receive |
|---|---|---|
| pulsed radiofrequency | Experimental | Not described Receives: Procedure: pulsed radiofrequency |
| Dry needling | Active comparator | Not described Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain VAS score
Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.
Measured: Postoperative six months
Secondary outcomes (7)
Pain VAS score
Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.
Measured: postoperaitve day 0 and postoperative 1 and 3 months
NDI
Neck disability index
Measured: postoperaitve day 0 and postoperative 1, 3 and 6 months
PHQ9
patient health questionnaire
Measured: postoperaitve day 0 and postoperative 1, 3 and 6 months
GAD7
generalized anxiety disorder (GAD-7) scale
Measured: 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
Measured: postoperaitve day 0 and postoperative 1, 3 and 6 months
SF36
health related quality of life short form 36 scale
Measured: 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.
Measured: postoperaitve day 0 and postoperative 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Wang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637047
- Sponsor's protocol ID
- PRFversusDN
- Status last verified
- May 2023
- First submitted
- 27 Nov 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang J, Zhang Y, Cui X, Shen L. Ultrasound-guided pulsed radiofrequency versus dry needling for pain management in chronic neck and shoulder myofascial pain syndrome patients at a tertiary hospital in China: a randomised controlled trial protocol. BMJ Open. 2023 May 24;13(5):e071422. doi: 10.1136/bmjopen-2022-071422.
PubMed 37225266
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05637047
- Acronym / sponsor ID
- PRFversusDN
- Conditions
- Myofascial Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 5 Dec 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulsed radiofrequency | Experimental | Procedure: pulsed radiofrequency |
| Dry needling | Active comparator | Procedure: 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)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| pulsed radiofrequencyultrasound-guided intramuscular and interfascial pulsed radiofrequency ablation | Procedure or surgery | pulsed radiofrequency |
| Dry needlingultrasound-guided intramuscular and interfascial dry needling | Procedure or surgery | Dry needling |
Primary outcome
Pain VAS score
Time frame: Postoperative six months
Pain evaluated by a 100mm line, 0mm indicates no pain, 100mm indicates the worst pain imaginable.
7 secondary outcomes
Pain VAS score
Time frame: postoperaitve day 0 and postoperative 1 and 3 months
NDI
Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months
PHQ9
Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months
GAD7
Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months
Sleep status
Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months
SF36
Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months
Mechanical pain threshold
Time frame: postoperaitve day 0 and postoperative 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 37225266Wang J, Zhang Y, Cui X, Shen L. Ultrasound-guided pulsed radiofrequency versus dry needling for pain management in chronic neck and shoulder myofascial pain syndrome patients at a tertiary hospital in China: a randomised controlled trial protocol. BMJ Open. 2023 May 24;13(5):e071422. doi: 10.1136/bmjopen-2022-071422.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed radiofrequency and 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 9 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: status not confirmed, as of the sponsor's last update on 6 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain VAS score (time frame: Postoperative six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637047, which also lists 1 linked publication.
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 6 May 2023.