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

May 19, 2026 updated by: Hongyi Chen, Guangzhou University of Chinese Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From the beginning of recruitment to the second week after the end of treatment at 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
visual analogue scale
Time Frame: From the beginning of recruitment to the second week after the end of treatment at 4 weeks
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
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
From the beginning of recruitment to the second week after the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou University of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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