- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00888524
Plus Deep Water Running on Low Back Pain (+DWR)
Evidence-Based Physiotherapy With and Without Deep Water Running on Non-Specific Low Back Pain. A Randomized Controlled Trial
Objectives: To evaluate the effect size on non-specific chronic low back pain (CLBP) of evidence-based physiotherapy (EBP) with and without the addition of deep water running (DWR) on pain, physical disability and general health state.
Materials and methods: Randomized, double-blind, controlled trial (therapists and assessors) involving 46 persons with CLBP over 15 weeks with two interventions, presented three times a week. Each group received EBP (personalized exercise program, manual therapy and health education) while one group performed supplementary 20 min sessions of DWR at the individualized aerobic threshold. Measurements were made pre and post intervention for pain, disability and general health. Range of motion of lumbar spine in the sagittal plane, maximum isometric strength and muscle endurance of lumbar and hip extensors was assessment.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Malaga, Spanien
- School Medicine University of Malaga
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Participants were diagnosed with non-specific CLBP, with no radiation to the legs, and lasting at least three months
Exclusion Criteria:
- Low back pain as a result of specific spinal disease, infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or caudal equine syndrome
- Patients not able to follow instructions
- Patients with any digressive condition
Studieplan
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: General Practice (GP) in Physio plus Deep water running
A supplementation of Deep Water running exercises of 20 minutes in high intensity around aerobic thresholds estimated in individual land and water test
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GP in Physio plus a supplementation of DWR training in high intensive aerobic threshold
|
|
Eksperimentel: General Practice in Physio
A procedure of evidence-based physiotherapy is usual care in pragmatic trial
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manual therapy, educational advice of health promotion and physical exercises therapy based in a individual assessment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
pain in VAS
Tidsramme: scale 0 -100, pre and post intervention and follow up 6 and 12 month
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scale 0 -100, pre and post intervention and follow up 6 and 12 month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
disability RMQ
Tidsramme: scale 0-24, pre and post intervention and follow up 6 and 12 month
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scale 0-24, pre and post intervention and follow up 6 and 12 month
|
|
general (mental and physical) health state with SF-12
Tidsramme: scale 0 -100, pre and post intervention and follow up 6 and 12 month
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scale 0 -100, pre and post intervention and follow up 6 and 12 month
|
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functional Measurements: range on motion in degrees with inclinometer dual, strength with lineal dynamometer (newton) and endurance muscular with soerensen test (seconds)
Tidsramme: scale physica of degrees, newtons and seconds pre post intervention and 6 and 12 month of follow up
|
scale physica of degrees, newtons and seconds pre post intervention and 6 and 12 month of follow up
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Antonio Cuesta-Vargas, PhD, University of Malaga
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 857 IAC 0630041300
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