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Influence of Health Determinants on Physical Exercise Therapy With a Neurocognitive Focus on Chronic Low Back Pain

3. oktober 2019 opdateret af: Fundació Universitària del Bages

Influence of Health Determinants and Therapeutic Alliance on the Effectiveness of a Pain Neuroscience Education Combined With Motor Control Training With Neurocognitive Focus on Chronic Lumbar Pain in a Population of Professional Caregivers

Protocols in which pain neuroscience education is combined with physical exercise have shown recently greater effectiveness in the treatment of low back pain in comparison to protocols based only on one of the two approaches. The professional caregiver has a high incidence of low back pain related to the specific aspects of this collection with the low physical condition, the typical tasks performed and other psychosocial aspects. Individual characteristics of these caregivers may condition the effectiveness of the therapy as well as demographic aspects or the alliance between patient and physiotherapist. The aim of this study is to determine the influence of certain health determinants on the effectiveness of a therapy that combines pain neuroscience education and motor control training from a neurocognitive perspective on chronic low back pain in a population of professional caregivers in Bages, analyzing the reduction of low back pain, the improvement of functionality, the reduction of muscle movement and the improvement of muscle coordination.

It will be a quasi-experimental pre-post design, prospective, with a control group, lasting 3 months. The intervention will be performed using a sample of professional caregivers, and the data will be collected before the intervention, at the end of the intervention, and 3-6 months after the intervention. Pain, functionality, conducts of fear/avoidance, and muscular coordination will be analyzed

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Spanien
    • Barcelona
      • Manresa, Barcelona, Spanien, 08242
        • Universitat de Vic-Universitat de Catalunya (UVic-UCC)

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Of legal age
  • Participants who present lumbar or lumbosacral pain all the time for more than 1 year
  • Score of 6 on the Visual Analogical Scale
  • Have been at work (same position) longer than 1 year

Exclusion Criteria:

  • Other alterations and diseases of the musculoskeletal system that may interfere with the results of the intervention.
  • Pregnancy during the study time
  • Older than 65 years old

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: Ikke-randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: specific intervention (experimental)
Specific intervention (experimental). The intervention group will carry out 3 sessions of specific pain education + 15 sessions of physical training.
Adfærdsmæssigt: Group of educational intervention on the neurophysiology of pain and physical exercises

The physiotherapist of the institution will execute the intervention on the group:

  • 3 first pedagogical sessions on the neurophysiology of pain, distributed: 1 group session, 1 individual session at home, 1 in a personal interview format. These 3 sessions will last 2 weeks to be completed.
  • Afterward, the protocol of physical exercise training will begin, supervised by the same physiotherapist who carried out the three initial sessions. There will be 15 sessions of specific and individualized physical exercise, in small groups of maximum 5 people. The duration of this part will be 10 weeks, so that from week 1 to 5 is 2 times per week, and from week 6 to 10 just 1 time per week.
Aktiv komparator: control group (no intervention)
NO intervention
Adfærdsmæssigt: Control group
The control group will follow its normal course of activity

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Pain perceived at 3 months: Visual Analogue Scale
Tidsramme: Baseline and 3 months
Analisis of pain, using the Visual Analogue Scale, that measure from 0 (no pain) to 10 (excruciating pain)
Baseline and 3 months
Change from Baseline in Pain perceived at 6 months: Visual Analogue Scale
Tidsramme: Baseline and 6 months
Analisis of pain, using the Visual Analogue Scale, that measure from 0 (no pain) to 10 (excruciating pain)
Baseline and 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Fear and avoidance of movement at 3 months
Tidsramme: Baseline and 3 months
Tampa Scale of Kinesophobia, a scale with 11 items, the rating ranges from 11 points to 44 points. A high value indicates that there is a high degree of fear of movement.
Baseline and 3 months
Change from Baseline in Pain disability at 3 months: Oswestry Disability Index
Tidsramme: Baseline and 3 months
Oswestry Disability Index, This scale consists of 10 questions, each of them with answers graduated from 0 (no relevant) to 5 (very relevant), from which the % of disability of the individual is obtained from the formula: Total points of the answers / 50 *100= % disabled
Baseline and 3 months

Samarbejdspartnere og efterforskere

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

Sponsor

Fundació Universitària del Bages

Efterforskere

  • Ledende efterforsker: Júlia Jubany, PhD, Universitat de Vic-Universitat Central de Catalunya

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 (Forventet)

2. december 2019

Primær færdiggørelse (Forventet)

30. april 2020

Studieafslutning (Forventet)

20. december 2020

Datoer for studieregistrering

Først indsendt

1. oktober 2019

Først indsendt, der opfyldte QC-kriterier

3. oktober 2019

Først opslået (Faktiske)

4. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UManresa_Caregivers2019

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Data about the protocol intervention, primary outcome measures and final report will be available for the Institution director.

IPD-delingstidsramme

Before the intervention starts

IPD-delingsadgangskriterier

Only for institution director

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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