Peng's "Fenjin Tuina" for Superior Cluneal Nerve Entrapment Syndrome: A Prospective, Randomized, Single-center Trial

NCT07603154 | Enrolling By Invitation

• 1 other identifier: YF2026-162-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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". 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

Outcome Measures

Primary Outcomes (1)

• 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.

  From the beginning of recruitment to the second week after the end of treatment at 4 weeks

Secondary Outcomes (3)

• visual analogue scale

  From the beginning of recruitment to the second week after the end of treatment at 4 weeks

• Japanese Orthopaedic Association Scores

  From the beginning of recruitment to the second week after the end of treatment at 4 weeks

• Oswestry Disability Index

  From the beginning of recruitment to the second week after the end of treatment at 4 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

Other: Peng's "Fenjin Tuina"

control group

ACTIVE COMPARATOR

Other: conventional massage therapy

Interventions

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.

experimental group

conventional massage therapy OTHER

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.

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Guangzhou University of Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510030, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 22, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): April 23, 2027
• Study Completion (Estimated): April 23, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)