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Sensorimotor Training in Low-back Pain Rehabilitation (SeMoPoP)

5. april 2016 opdateret af: Michael A. McCaskey

Effects of a Sensorimotor Training on Postural Control and Pain: A Parallel, Single-blinded Randomised Controlled Trial

This study evaluates the effects of additional sensorimotor training (proprioceptive postural training, PPT) to conventional therapy in the treatment of chronic low-back pain. Half of the participants will receive instructed treadmill training as an active comparator against PPT. All participants receive conventional physiotherapy as prescribed by their treating medical doctors. It is expected that the PPT group will improve in postural control, proprioceptive, as well as pain and function outcomes to a significantly greater extent than the active control group.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Schweiz
    • Aargau
      • Rheinfelden, Aargau, Schweiz, 4310
        • Reha Rheinfelden

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with musculoskeletal low back pain (non-specific low back pain)
  • Age ≥ 18 years

Exclusion Criteria:

  • Known or suspected neurological diseases or lesions
  • Traumatic injury of musculoskeletal system (fractures, tumours)
  • Spinal pathologies (e.g., tumour, infection, fracture, and inflammatory disease)
  • Previous spinal surgery
  • Presence of any contraindication to exercise (fracture or cardiovascular limitations)

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: Sensorimotor
The experimental group will receive added PPT to the conventional physiotherapy. PPT will be applied by means of a neuro-orthopaedic medical device ("Posturomed®", see section 3.2). The "Posturomed" allows adaptive oscillation in the horizontal plane. Therapy instructions advise seven stages of difficulty. In all stages the patient is asked to provoke oscillation by stepping on site. After three steps, the patient must stand still on one leg for 2 seconds before he or she repeats the steps. Difficulty is increased by a) decreasing the damping through release of the breaks and b) through added juggling of a ball during the motor task (dual-task and divided attention). The next stage is reached once stabilisation in the previous stage is secured.
Andet: Proprioceptive postural training
Andre navne:
  • Sensorimotor training
Andet: Conventional physiotherapy
All participating patients will attend usual care according to their treatment plan (taking part in the study does not affect the treatment plan). A physiotherapy referral requests 9 treatments, each of which takes 30 minutes. These will take place twice a week for 4.5 weeks. The study protocol does not dictate the content of the physiotherapy sessions themselves, but detailed documentation of provided treatments is required (therapy documentation sheet). Additionally, the aim of the physiotherapy sessions should always include reduction of muscular imbalances and optimisation of posture.
Aktiv komparator: Low-intensity activity
Added to conventional therapy, as administered to all participants, the control group will do added treadmill walking. The control intervention will consist of 10 minutes of walking at comfortable pace. The patient will be instructed in treadmill functions and asked to set the speed between 2 and 4 km/h. The speed should be adjusted to the level where the patient would still be able to talk comfortably.
Andet: Conventional physiotherapy
All participating patients will attend usual care according to their treatment plan (taking part in the study does not affect the treatment plan). A physiotherapy referral requests 9 treatments, each of which takes 30 minutes. These will take place twice a week for 4.5 weeks. The study protocol does not dictate the content of the physiotherapy sessions themselves, but detailed documentation of provided treatments is required (therapy documentation sheet). Additionally, the aim of the physiotherapy sessions should always include reduction of muscular imbalances and optimisation of posture.
Andet: Treadmill training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change of self-reported pain on 100mm Visual Analogue Scale (VAS)
Tidsramme: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Change of functional status recorded with the Oswestry Disability Index (ODI)
Tidsramme: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Centre of Pressure
Tidsramme: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Area of surface a the 95% confidence ellipse of centre of pressure displacement during postural task
Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Joint Repositioning Error (segmental)
Tidsramme: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Repositioning acuity after surface perturbation.
Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Uncontrolled Manifold Index (UCM)
Tidsramme: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Segmental joint configuration.
Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)

Samarbejdspartnere og efterforskere

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

Sponsor

Michael A. McCaskey

Samarbejdspartnere

University of Zurich

Efterforskere

  • Ledende efterforsker: Michael A McCaskey, MSc, Reha Rheinfelden
  • Studiestol: Eling D. de Bruin, PD PhD, ETH Zurich
  • Studiestol: Corina Schuster-Amft, PT PhD, Reha Rheinfelden

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

1. december 2014

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

17. november 2014

Først indsendt, der opfyldte QC-kriterier

25. november 2014

Først opslået (Skøn)

1. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2014-0873

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 .

Kliniske forsøg med Lændesmerter

Kliniske forsøg med Proprioceptive postural training

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Betingelser

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Placeringer

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