Chronic Low Back Pain: A Multidisciplinary Approach (CLBP-HUVH)
15. juni 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
66
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Barcelona, Spania, 08035
- Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
30 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: TAU
Control group.
Treatment as usual (TAU): Physiotherapy program for CLBP.
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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 navn:
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Eksperimentell: Intervention 1 Relaxation techniques-sophrology
Intervention group 1: TAU + relaxation techniques-sophrology program.
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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 navn:
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 navn:
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Eksperimentell: Intervention 2 Cognitive-behavioral therapy
Intervention group 2: TAU + cognitive-behavioral therapy.
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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 navn:
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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The SF-12v2 Health Status Questionnaire (change is being assessed)
Tidsramme: Baseline, 6 and 12 months
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The SF-12 measures health-related quality of life including items from various domains both physical and psychological.
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Baseline, 6 and 12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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VAS for Self-perceived Pain
Tidsramme: Baseline, 6 and 12 months
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Visual Analogue Scale to rate self-perceived pain.
Recall period: last 4 weeks.
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Baseline, 6 and 12 months
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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).
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Baseline, 6 and 12 months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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LISAT-8
Tidsramme: Baseline, 6 and 12 months
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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.
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Baseline, 6 and 12 months
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STAI
Tidsramme: Baseline, 6 and 12 months
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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.
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Baseline, 6 and 12 months
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BDI-13
Tidsramme: Baseline, 6 and 12 months
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The Beck Depression Inventory (BDI) is a 13-item (short-form), self-report rating inventory that measures characteristic attitudes and symptoms of depression.
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Baseline, 6 and 12 months
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PSQI
Tidsramme: Baseline, 6 and 12 months
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The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality during the previous month.
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Baseline, 6 and 12 months
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CAD
Tidsramme: Baseline and 12 months
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The CAD (Cuestionario para el Afrontamiento al Dolor) is a coping questionnaire to chronic pain developed in a Spanish sample.
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Baseline and 12 months
|
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TAS-20
Tidsramme: Baseline and 12 months
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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).
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Baseline and 12 months
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PSS-14
Tidsramme: Baseline and 12 months
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The Perceived Stress Scale (PSS) is a 14-item questionnaire that measures the degree to which life events are considered stressful.
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Baseline and 12 months
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DUKE-11
Tidsramme: Baseline and 12 months
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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.
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Baseline and 12 months
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VAS for patient satisfaction with treatment received
Tidsramme: Baseline, 6 and 12 months
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Visual Analogue Scale to rate patients' satisfaction with treatment, attention received and outcomes.
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Baseline, 6 and 12 months
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Medical and demographics
Tidsramme: Baseline
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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.
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Baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Carmina Castellano-Tejedor, PhD, Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron
- Studieleder: Elisa Barnola-Serra, MD, Hospital Vall d'Hebrón
- Studiestol: Gemma Costa-Requena, MsC, Hospital Vall d'Hebrón
- Studiestol: Pilar Lusilla-Palacios, MD, PhD, Hospital Vall d'Hebrón
- 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'Hebrón
- Studiestol: Ana Palacios-González, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- Studiestol: Tamara Biedermann-Villagra, MD, Hospital Vall d'Hebrón
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2013
Primær fullføring (Faktiske)
1. november 2014
Studiet fullført (Faktiske)
1. januar 2015
Datoer for studieregistrering
Først innsendt
11. november 2013
Først innsendt som oppfylte QC-kriteriene
19. november 2013
Først lagt ut (Anslag)
25. november 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. juni 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. juni 2015
Sist bekreftet
1. juni 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CLBP-PT_ATR_274-2012
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