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

19. maj 2026 opdateret af: 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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: forsøgsgruppe
Andet: 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.
Aktiv komparator: kontrolgruppe
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in patient's local pain threshold and pain tolerance threshold
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tidsramme
visual analogue scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Guangzhou University of Chinese Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. april 2026

Primær færdiggørelse (Anslået)

23. april 2027

Studieafslutning (Anslået)

23. april 2027

Datoer for studieregistrering

Først indsendt

5. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • YF2026-162-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Peng's "Fenjin Tuina"

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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