SCNESNCT07603154
Peng's "Fenjin Tuina" for Superior Cluneal Nerve Entrapment Syndrome: A Prospective, Randomized, Single-center Trial
A study testing Peng's "Fenjin Tuina" and conventional massage therapy in people with SCNES and Superior Cluneal Nerve Entrapment Syndrome, run by Guangzhou University of Chinese Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if Peng's "Fenjin Tuina" works to treat superior cluneal nerve entrapment syndrome in adults. It will also learn about the safety of Peng's "Fenjin Tuina". Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- SCNES, Superior Cluneal Nerve Entrapment Syndrome
- What is being tested?
- Peng's "Fenjin Tuina" and conventional massage therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2026to 23 Apr 2027
- 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
- 1. Those meeting the diagnostic criteria for superior cluneal nerve entrapment syndrome as described in "Perineal Nerve Entrapment Syndrome"; 2. Age ranging from 18 to 70 years (inclusive of 18 and 70), gender not limited; 3. Good compliance and able to undergo massage therapy; 4. Capable of understanding the contents of the scale and questionnaire, and willing to participate in this clinical study and sign the informed consent form.
Who cannot join
- 1. Other patients not meeting the diagnostic criteria for superior cluneal nerve entrapment syndrome; 2. Those with large areas of skin damage on the lumbar region and the posterior lateral part of the thigh; 3. Those who have received other related treatments and may affect the observation indicators of this study; 4. Those who cannot be evaluated for efficacy, such as those who cannot understand the contents of the scale; 5. Nursing mothers or pregnant women or those preparing for pregnancy; 6. Those with severe life-threatening primary diseases such as cardiovascular, liver, kidney and hematopoietic system diseases, as well as patients with mental illness or those with legally infectious diseases; 7. Those diagnosed with progressive malignant tumors or other serious consuming diseases prone to or with infectious diseases such as infections and bleeding; 8. Those with severe osteoporosis or tumor bone metastasis; 9. Those taking anticoagulant or antithrombotic drugs; 10. Those who voluntarily give up or cannot cooperate with treatment, observation or examination for various reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510030
About this study
Official title: Clinical Efficacy Observation Project of Peng's "Fenjin Tuina" in Treating Superior Cluneal Nerve Entrapment Syndrome
The goal of this clinical trial is to learn if Peng's "Fenjin Tuina" works to treat superior cluneal nerve entrapment syndrome in adults. It will also learn about the safety of Peng's "Fenjin Tuina". The main questions it aims to answer are:Did Peng's "Fenjin Tuina" therapy improve the pain symptoms of participants; Will participants experience health problems using Peng's "Fenjin Tuina" therapy;Researchers will compare Peng's "Fenjin Tuina" with conventional massage therapy to see if Peng's "segmented massage" can treat superior cluneal nerve entrapment syndrome.Participants will visit the clinic once a week for checkups and treatments.
- Conditions
- SCNES, Superior Cluneal Nerve Entrapment Syndrome
- Being tested
- Peng's "Fenjin Tuina", conventional massage therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peng's "Fenjin Tuina"Other
Using Peng's "Fenjin Tuina" therapy for treatment, which is a physical therapy. The above treatment is administered once every 7 days, with 3 sessions constituting one course of treatment. A total of 1 course of treatment.
conventional massage therapyOther
Using conventional massage therapy for treatment. The above treatment is administered once every 7 days, with 3 sessions constituting one course of treatment. A total of 1 course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Other: Peng's "Fenjin Tuina" |
| control group | Active comparator | Not described Receives: Other: conventional massage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patient's local pain threshold and pain tolerance threshold
Select the most prominent pain points on the waist and buttocks of the patients, and use the YISIDA DS2-100N electronic pain measurement instrument to measure the local pain threshold and pain tolerance threshold. During the operation, the examiner places the pain measurement probe vertically on the skin surface at a constant rate and applies pressure uniformly. When the patient clearly states "I feel pain" for the first time, immediately stop applying pressure and record the value at this moment, which is defined as the pain threshold. Then continue to slowly increase the pressure. When the patient states "The pain is unbearable and the stimulation must be stopped", immediately remove the probe and record this value; the pain tolerance threshold is equal to this value minus the pain threshold. Compare the results before and after this experiment, and judge the therapeutic effect by observing the changes in the pain threshold and pain tolerance threshold.
Measured: From the beginning of recruitment to the second week after the end of treatment at 4 weeks
Secondary outcomes (3)
visual analogue scale
Measured: From the beginning of recruitment to the second week after the end of treatment at 4 weeks
Japanese Orthopaedic Association Scores
Measured: From the beginning of recruitment to the second week after the end of treatment at 4 weeks
Oswestry Disability Index
Measured: From the beginning of recruitment to the second week after the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start23 Apr 2026
- Primary completion23 Apr 2027 (estimated)
- Study completion23 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCNESStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyi Chen, Guangzhou University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603154
- Sponsor's protocol ID
- YF2026-162-01
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 22 May 2026
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Observation Project of Peng's "Fenjin Tuina" in Treating Superior Cluneal Nerve Entrapment Syndrome
- ClinicalTrials.gov ID
- NCT07603154
- Acronym / sponsor ID
- YF2026-162-01
- Conditions
- SCNES, Superior Cluneal Nerve Entrapment Syndrome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Guangzhou University of Chinese MedicineUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 23 Apr 2027 (estimated)
- Study completion
- 23 Apr 2027 (estimated)
- First posted
- 22 May 2026 (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.
The goal of this clinical trial is to learn if Peng's "Fenjin Tuina" works to treat superior cluneal nerve entrapment syndrome in adults. It will also learn about the safety of Peng's "Fenjin Tuina". The main questions it aims to answer are:Did Peng's "Fenjin Tuina" therapy improve the pain symptoms of participants; Will participants experience health problems using Peng's "Fenjin Tuina" therapy;Researchers will compare Peng's "Fenjin Tuina" with conventional massage therapy to see if Peng's "segmented massage" can treat superior cluneal nerve entrapment syndrome.Participants will visit the clinic once a week for checkups and treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Peng's "Fenjin Tuina" |
| control group | Active comparator | Other: conventional massage therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Those meeting the diagnostic criteria for superior cluneal nerve entrapment syndrome as described in "Perineal Nerve Entrapment Syndrome"; 2. Age ranging from 18 to 70 years (inclusive of 18 and 70), gender not limited; 3. Good compliance and able to undergo massage therapy; 4. Capable of understanding the contents of the scale and questionnaire, and willing to participate in this clinical study and sign the informed consent form.
Key exclusion criteria (1 listed)
- 1. Other patients not meeting the diagnostic criteria for superior cluneal nerve entrapment syndrome; 2. Those with large areas of skin damage on the lumbar region and the posterior lateral part of the thigh; 3. Those who have received other related treatments and may affect the observation indicators of this study; 4. Those who cannot be evaluated for efficacy, such as those who cannot understand the contents of the scale; 5. Nursing mothers or pregnant women or those preparing for pregnancy; 6. Those with severe life-threatening primary diseases such as cardiovascular, liver, kidney and hematopoietic system diseases, as well as patients with mental illness or those with legally infectious diseases; 7. Those diagnosed with progressive malignant tumors or other serious consuming diseases prone to or with infectious diseases such as infections and bleeding; 8. Those with severe osteoporosis or tumor bone metastasis; 9. Those taking anticoagulant or antithrombotic drugs; 10. Those who voluntarily give up or cannot cooperate with treatment, observation or examination for various reasons.
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 |
|---|---|---|
| Peng's "Fenjin Tuina"Using Peng's "Fenjin Tuina" therapy for treatment, which is a physical therapy. The above treatment is administered once every 7 days, with 3 sessions constituting one course of treatment. A total of 1 course of treatment. | Other | experimental group |
| conventional massage therapyUsing conventional massage therapy for treatment. The above treatment is administered once every 7 days, with 3 sessions constituting one course of treatment. A total of 1 course of treatment. | Other | control group |
Primary outcome
Changes in patient's local pain threshold and pain tolerance threshold
Time frame: From the beginning of recruitment to the second week after the end of treatment at 4 weeks
Select the most prominent pain points on the waist and buttocks of the patients, and use the YISIDA DS2-100N electronic pain measurement instrument to measure the local pain threshold and pain tolerance threshold. During the operation, the examiner places the pain measurement probe vertically on the skin surface at a constant rate and applies pressure uniformly. When the patient clearly states "I feel pain" for the first time, immediately stop applying pressure and record the value at this moment, which is defined as the pain threshold. Then continue to slowly increase the pressure. When the patient states "The pain is unbearable and the stimulation must be stopped", immediately remove the probe and record this value; the pain tolerance threshold is equal to this value minus the pain threshold. Compare the results before and after this experiment, and judge the therapeutic effect by observing the changes in the pain threshold and pain tolerance threshold.
3 secondary outcomes
visual analogue scale
Time frame: From the beginning of recruitment to the second week after the end of treatment at 4 weeks
Japanese Orthopaedic Association Scores
Time frame: From the beginning of recruitment to the second week after the end of treatment at 4 weeks
Oswestry Disability Index
Time frame: From the beginning of recruitment to the second week after the end of treatment at 4 weeks
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 22 May 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peng's "Fenjin Tuina" and conventional massage therapy in people with SCNES and Superior Cluneal Nerve Entrapment Syndrome, run by Guangzhou University of Chinese Medicine at 1 site in China.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Changes in patient's local pain threshold and pain tolerance threshold (time frame: From the beginning of recruitment to the second week after the end of treatment at 4 weeks). 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 22 May 2026.