- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04694170
Visceral Somatization and Low Back Pain.
4. januar 2021 opdateret af: Malá Jitka, Charles University, Czech Republic
Physiotherapy of Patients With Low Back Pain of Viscerovertebral Etiology.
This study aims to verify the significance of the inclusion of procedures of a comprehensive therapeutic approach according to Eastern techniques to classical physiotherapy and to find out whether these Eastern techniques can contribute to the enrichment of standard physiotherapy.
According to TCM and Ayurveda, another goal is to develop appropriate regimen measures to create a yoga regimen suitable for patients who have renal and bladder dysfunction according to TCM and whose main common symptom is chronic non-specific low back pain.
The study is based upon comparing a four-week physiotherapy program according to the physician's indication and a physiotherapy program enriched with compiled regimen measures and yoga exercises in selected probands.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Two groups of probands were used - an experimental and control group.
There were 6 probands in each group.
The four-week therapy effect, which took place twice a week for 60 minutes, was compared.
The control group received physiotherapy, as indicated by the physician.
According to TCM and Ayurveda, the experimental group underwent physiotherapy as indicated by a doctor enriched with yoga exercises and regime measures.
It was asked to perform yoga exercises daily at home.
The therapy's effect was evaluated using the Short-form-36 Health-related Quality of Life Questionnaire (HRQoL), the VAS scale of pain intensity, the number of responses in the anamnestic questionnaire the author compiled the kinesiological analysis.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Praha, Tjekkiet
- Charles University, Faculty of physical education and sport
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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
26 år til 54 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- More than half of the answers in the anamnestic questionnaire (n ≥ 14)
- More than half of the answers in the kinesiological analysis (n ≥ 7)
- Lower back pain lasting longer than 12 weeks
- Degree of pain ≥ 3 on a visual analog scale
Exclusion Criteria:
- Neurological or other structural cause of lower back or other pain key symptoms
- Serious systemic diseases (DM, heart or cancer)
- Contraindications to movements of the spine and other root joints of the body in full scope
- Pregnancy
- Simultaneous completion of another physiotherapeutic intervention, yoga exercise or treatment according to TCM
- Use of analgesics, antiphlogistics or muscle relaxants during therapy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Experimental group
Patients with musculoskeletal pain in the lumbar region.
Patients with typical symptoms of functional dysfunction of kidney undergo conventional physiotherapy and an alternative approach by yoga set exercising and regimen restriction according to traditional Chinese medicine.
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Using conventional physiotherapy together with additional yoga exercising and regimen restriction acc to TCM.
Using conventional physiotherapy only.
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Aktiv komparator: control group
Patients with musculoskeletal pain in the lumbar region.
Patients with kidney dysfunction symptoms treated by conventional physiotherapy only.
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Using conventional physiotherapy only.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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level of quality of life
Tidsramme: 50 minutes
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using Short Form 36 questionnaire, minimum 100 points, less score is the sign of better quality of life, maximum = 900 points = the worst quality of life
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50 minutes
|
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intensity of pain
Tidsramme: 2 minutes
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visual analog scale 0-10, 0=the best and without pain, 10=the worst pain.
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2 minutes
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jitka Malá, PhDr.Ph.D., Charles University, Faculty of physical education and sport
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)
18. oktober 2019
Primær færdiggørelse (Faktiske)
15. december 2019
Studieafslutning (Faktiske)
10. januar 2020
Datoer for studieregistrering
Først indsendt
26. december 2020
Først indsendt, der opfyldte QC-kriterier
4. januar 2021
Først opslået (Faktiske)
5. januar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. januar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Sklepnikova, Kidney
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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