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Chronic Low Back Pain: A Multidisciplinary Approach (CLBP-HUVH)

15. juni 2015 opdateret af: Hospital Universitari Vall d'Hebron Research Institute

A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain

Introduction: Non-specific chronic low back pain (CLBP) is one of the most frequent causes for patient disability and a general recurrent cause for medical consultation with high costs to public health. From rehabilitative medicine, physiotherapy is commonly offered. Although this treatment is aimed to reduce disability, pain severity and pain-related anxiety-depressive symptoms, many patients report partial improvement and recurrent intensive and disabling pain episodes. Therefore, a new approach in the treatment and rehabilitation of this pathology that takes into account psychosocial aspects that might be modulating pain is necessary.

Material and methods: This project aims to assess the efficacy of two complementary interventions to standard physical therapy, such as relaxation techniques and cognitive-behavioral intervention, to improve health-related quality of life (HRQoL) among patients with CLBP. It is hypothesized that groups receiving these complementary interventions will significantly improve their adherence to physiotherapy and the control of their pain and, ultimately, these aspects will facilitate a decreasing of pain intensity and better HRQoL.

For these purposes, a pre-post longitudinal design will be carried out, with follow-up assessments at 6 and 12 months in a sample of 66 participants. This sample will be divided into: control group (physiotherapy), intervention group 1 (physiotherapy and relaxation techniques-sophrology) and intervention group 2 (physiotherapy and cognitive-behavioral intervention).

Expected impact: Study results are not available yet. However, if working hypotheses are confirmed, a multidisciplinary model of care for CLBP will be empirically justified. This approach is expected to benefit HRQoL among these patients implying a significant short-mid term reduction of public health costs.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

66

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, Spanien, 08035
        • Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron

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

30 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Non-specific chronic (> 6 months of evolution) low back pain diagnosis
  • Ability to read and speak in Spanish

Exclusion Criteria:

  • Addictive behaviors (DAST-10 > 3, alcoholism, drug addiction or other drug abuse)
  • Psychiatric contraindications (BDI > 15 or other severe psychiatric disorder not stabilized)
  • Neurological impairment
  • No mental competence (MEC < 23)
  • Fibromyalgia and/or chronic fatigue

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: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: TAU
Control group. Treatment as usual (TAU): Physiotherapy program for CLBP.
Andet: Physiotherapy
Physical therapy exercise program for CLBP patients. Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.
Andre navne:
  • Behandling som sædvanlig (TAU)
Eksperimentel: Intervention 1 Relaxation techniques-sophrology
Intervention group 1: TAU + relaxation techniques-sophrology program.
Andet: Physiotherapy
Physical therapy exercise program for CLBP patients. Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.
Andre navne:
  • Behandling som sædvanlig (TAU)
Andet: Intervention 1
Relaxation techniques-sophrology consists of a set of physical and relaxation exercises that include breathing methods, visualization, modification of states of consciousness, etc. with the goal to enhance balance between body and mind to improve health-related quality of life, reduce pain and foster patients' well-being.
Andre navne:
  • Relaxation techniques-sophrology
Eksperimentel: Intervention 2 Cognitive-behavioral therapy
Intervention group 2: TAU + cognitive-behavioral therapy.
Andet: Physiotherapy
Physical therapy exercise program for CLBP patients. Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.
Andre navne:
  • Behandling som sædvanlig (TAU)
Adfærdsmæssigt: Intervention 2
Cognitive-behavioral therapy (in combination with motivational interviewing principles) is aimed to facilitate psychological adjustment and self-management of CLBP with the ultimate goal of increasing patients' health-related quality of life and well-being.
Andre navne:
  • CBT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The SF-12v2 Health Status Questionnaire (change is being assessed)
Tidsramme: Baseline, 6 and 12 months
The SF-12 measures health-related quality of life including items from various domains both physical and psychological.
Baseline, 6 and 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
VAS for Self-perceived Pain
Tidsramme: Baseline, 6 and 12 months
Visual Analogue Scale to rate self-perceived pain. Recall period: last 4 weeks.
Baseline, 6 and 12 months
Oswestry-15 Disability Index
Tidsramme: Baseline, 6 and 12 months
The Oswestry Disability Index (aka: Oswestry Low Back Pain Disability Questionnaire) is a time-tested outcome assessment tool that is used to measure a patient's impairment and quality of life (i.e., how badly the pain has affected their life).
Baseline, 6 and 12 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
LISAT-8
Tidsramme: Baseline, 6 and 12 months
The LISAT is a domain-specific measure of life satisfaction, which corresponds to Box E (subjective evaluations and reactions; life satisfaction) of Dijker's Model.
Baseline, 6 and 12 months
STAI
Tidsramme: Baseline, 6 and 12 months
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to screen anxiety and to distinguish it from depressive syndromes.
Baseline, 6 and 12 months
BDI-13
Tidsramme: Baseline, 6 and 12 months
The Beck Depression Inventory (BDI) is a 13-item (short-form), self-report rating inventory that measures characteristic attitudes and symptoms of depression.
Baseline, 6 and 12 months
PSQI
Tidsramme: Baseline, 6 and 12 months
The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month.
Baseline, 6 and 12 months
CAD
Tidsramme: Baseline and 12 months
The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample.
Baseline and 12 months
TAS-20
Tidsramme: Baseline and 12 months
The Toronto Alexithymia Scale (TAS) 20-item is one of the most commonly used measures of alexithymia (people who have trouble identifying and describing emotions and who tend to minimise emotional experience and focus attention externally).
Baseline and 12 months
PSS-14
Tidsramme: Baseline and 12 months
The Perceived Stress Scale (PSS) is a 14-item questionnaire that measures the degree to which life events are considered stressful.
Baseline and 12 months
DUKE-11
Tidsramme: Baseline and 12 months
The DUKE 11-item social support questionnaire measures an individual's perception of the amount and type of personal social support. The original instrument included 14 items, grouped into 4 subscales: Quantity of Support, Confidant Support, Affective Support, and Instrumental Support.
Baseline and 12 months
VAS for patient satisfaction with treatment received
Tidsramme: Baseline, 6 and 12 months
Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes.
Baseline, 6 and 12 months
Medical and demographics
Tidsramme: Baseline
Medical (medical and psychopathological history, physical exploration of LBP and possible substance abuse or other toxic habits such as alcohol or tobacco) and demographics (age, gender, immediate family network, education, job and SES) of patients are collected according to standard procedures.
Baseline

Samarbejdspartnere og efterforskere

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

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Efterforskere

  • Ledende efterforsker: Carmina Castellano-Tejedor, PhD, Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron
  • Studieleder: Elisa Barnola-Serra, MD, Hospital Vall d'Hebron
  • Studiestol: Gemma Costa-Requena, MsC, Hospital Vall d'Hebron
  • Studiestol: Pilar Lusilla-Palacios, MD, PhD, Hospital Vall d'Hebron
  • Studiestol: Alex Ginés-Puertas, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
  • Studiestol: Laura Camprubí-Roca, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
  • Studiestol: Mª Lluisa Torrent-Bertran, MD, Hospital Vall d'Hebron
  • Studiestol: Ana Palacios-González, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
  • Studiestol: Tamara Biedermann-Villagra, MD, Hospital Vall d'Hebron

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

  • Group of pain for patients with chronic low back pain: A multidisciplinary intervention. Lusilla-Palacios, P, Castellano-Tejedor, C, Barnola-Serra, E, Ramos-Rondón, C, Biedermann-Villagra, T, Torrent-Bertran, M.L, Costa-Requena, G, Camprubí-Roca, L, Palacios-González, A, Cuxart-Fina, A, Ginés-Puertas, A, Bosch-Graupera, A. Poster communication on the 21th European Congress of Psychiatry, Nice, France, 25-29/05/2010.
  • Castellano-Tejedor, C., Costa-Requena, G., Lusilla-Palacios, P., Biedermann-Villagra, T., Barnola-Serra, E. Calidad del sueño en pacientes con lumbalgia crónica inespecífica. Rehabilitación 48(4): 219-225, 2014. DOI: 10.1016/j.rh.2014.05.003
  • Castellano-Tejedor, C., Costa-Requena, G., Lusilla-Palacios, P., Barnola-Serra, E. Calidad de vida en pacientes con dolor lumbar crónico: efectos de un programa de intervención multidisciplinar a los 6 meses de seguimiento. Comunicació tipus pòster presentada a les II Jornades BiblioPro del Parc de Recerca Biomédica de Barcelona, Barcelona 19 de febrer de 2015.

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. marts 2013

Primær færdiggørelse (Faktiske)

1. november 2014

Studieafslutning (Faktiske)

1. januar 2015

Datoer for studieregistrering

Først indsendt

11. november 2013

Først indsendt, der opfyldte QC-kriterier

19. november 2013

Først opslået (Skøn)

25. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLBP-PT_ATR_274-2012

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 .

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