Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome

25. maj 2022 opdateret af: Xiaodan Shi, Tongji University

The Efficacy and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Abdominal Pain and Other Symptoms in Patients With Constipation-predominant Irritable Bowel Syndrome

This study aims to investigate the effects and possible mechanisms of transcutaneous auricular vagal nerve stimulation (taVNS) on abdominal pain and other symptoms in patients with IBS-C.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is designed as an early-feasibility, single-center, single-blinded, randomized controlled trial (RCT), in which subjects are consented, undergo a baseline assessment, and receive taVNS or sham-taVNS treatment twice a day (8 a.m. and 8 p.m.) for 30 minutes each time for a period of 4 weeks. The taVNS and sham-taVNS treatment was applied using the commercially-available Transcutaneous Electrical Applicator device (Model SNM-FDC01, Ningbo MedKinetic Medical Device Co., Ltd.) with the skin electrodes placed bilaterally on auricular concha. The patients are requested to score the abdominal pain (using VAS) and complete BSFS, IBS-SSS, IBS-QOL, SAS, and SDS forms every week and fill out the bowel diary during taVNS or sham-taVNS. Emergency medications (Macrogol 4000 and pinaverium) are permitted for use when the patient cannot tolerate symptoms of constipation and abdominal pain.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kina
      • Shanghai, Kina, 200120
        • Shanghai East Hospital, Tongji University School of 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

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. willing to sign a written informed consent form
  2. met the Rome IV diagnostic criteria for IBS-C

Exclusion Criteria:

  1. history of previous abdominal surgery (other than appendectomy)
  2. presence of carcinoma
  3. any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, Parkinson's disease, or spinal cord injury
  4. taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors
  5. serious concomitant disease of the heart, liver, kidney, or diabetes
  6. pregnancy or lactation
  7. participating in another trial or enrolled in a trial during the past month
  8. allergic reaction to surface electrodes

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: taVNS treatment
The taVNS treatment is performed at auricular cymba concha. The stimulation parameters are set as follows: train on-time of 2 seconds and off-time of a 3-second pulse width of 0.5 ms, pulse frequency of 25 Hz, and amplitude of 0-2 milliamp (at the maximum level tolerated by the subject).
Enhed: taVNS
transcutaneous auricular vagal nerve stimulation
Sham-komparator: sham-taVNS treatment
Sham-taVNS is performed with the same parameters as taVNS except that electrical stimulation is applied at the elbow area.
Enhed: sham-taVNS
transcutaneous stimulation at the elbow area

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in аbdominal pain between sham and active taVNS
Tidsramme: 4 weeks
Weekly average of daily patient-assessed abdominal pain using the visual analog scale (VAS). VAS ranges from 0 to 10, with 0 indicating no abdominal pain and 10 indicating the maximal pain. Efficacy is evaluated as an improvement of ≥ 30%.
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in IBS symptom severity scale (IBS-SSS) between sham and active taVNS
Tidsramme: 4 weeks
Questionnaire consists of 5 questions (abdominal pain intensity, abdominal pain frequency, abdominal distension degree, defecation satisfaction, and interference with quality of life), with a total score of 500 points and a higher score indicating a worse condition. Scores < 175 represent mild IBS symptoms, scores 175-300 represent moderate severity, and scores > 300 represent severe IBS.
4 weeks
Change in IBS quality of life (IBS-QOL) between sham and active taVNS
Tidsramme: 4 weeks
Questionnaire is composed of 8 dimensions (dysphoria, interference with activity, body image, health concerns, food avoidance, social reaction, sex, and relationships), with 34 items assessing the degree to which IBS interferes with the patient's quality of life. Each item is evaluated on a 5-point Likert scale. The total score ranges from 34 to 170 and higher scores indicate better quality of life.
4 weeks
Change in Bristol stool form scale (BSFS) between sham and active taVNS
Tidsramme: 4 weeks
The scale has 7 points according to stool type, from the hardest (1) to the softest (7). The lower the score, the more severe is constipation.
4 weeks
Change in Self-Rating Anxiety Scale (SAS) score between sham and active taVNS
Tidsramme: 4 weeks
SAS questionnaire has 20 items to assess physical and psychological symptoms, using a 4-point Likert scale ranging from 1 (none, or a little of the time) to 4 (most, or all of the time), with a total score ranging from 20 to 80. SAS scores below 50 indicate no anxiety, from 50 to 59 - mild anxiety, from 60 to 69 - moderate anxiety, 70 and above - severe anxiety.
4 weeks
Change in Self-Rating Depression Scale (SDS) score between sham and active taVNS
Tidsramme: 4 weeks
SDS questionnaire has 20 items to assess physical and psychological symptoms, using a 4-point Likert scale ranging from 1 (none, or a little of the time) to 4 (most, or all of the time), with a total score ranging from 20 to 80. SDS scores below 50 indicate no depression, from 50 to 59 - mild depression, from 60 to 69 - moderate depression, 70 and above - severe depression.
4 weeks
Change in complete spontaneous bowel movements per week between sham and active taVNS
Tidsramme: 4 weeks
Number of bowel movements that occur without use of any medication or other methods to assist defecation and with a feeling of complete evacuation
4 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in autonomic function assessed by the spectral parameters of heart rate variability between sham and active stimulation
Tidsramme: 4 weeks
Heart rate variability parameters are calculated using spectral analysis of R-R intervals in electrocardiogram (ECG)
4 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Tongji University

Samarbejdspartnere

Shanghai East Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

1. marts 2020

Primær færdiggørelse (Faktiske)

15. december 2020

Studieafslutning (Faktiske)

15. december 2020

Datoer for studieregistrering

Først indsendt

21. maj 2022

Først indsendt, der opfyldte QC-kriterier

24. maj 2022

Først opslået (Faktiske)

26. maj 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2020-006

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner