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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: SCNES; Superior Cluneal Nerve Entrapment Syndrome
• Intervention / Treatment: Other: Peng's "Fenjin Tuina"; Other: conventional massage therapy

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Guangdong Provincial Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group	Other: 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.
Active Comparator: control group	Other: conventional massage therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Guangzhou University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2026
• Primary Completion (Estimated): April 23, 2027
• Study Completion (Estimated): April 23, 2027

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: YF2026-162-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No