Chronic Low Back Pain: A Multidisciplinary Approach (CLBP-HUVH)
15 juni 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
66
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Barcelona, Spanje, 08035
- Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
30 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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.
Andere namen:
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Experimenteel: 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.
Andere namen:
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The SF-12v2 Health Status Questionnaire (change is being assessed)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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VAS for Self-perceived Pain
Tijdsspanne: 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
Tijdsspanne: Baseline, 6 and 12 months
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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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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LISAT-8
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Carmina Castellano-Tejedor, PhD, Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron
- Studie directeur: Elisa Barnola-Serra, MD, Hospital Vall d'Hebron
- Studie stoel: Gemma Costa-Requena, MsC, Hospital Vall d'Hebron
- Studie stoel: Pilar Lusilla-Palacios, MD, PhD, Hospital Vall d'Hebron
- Studie stoel: Alex Ginés-Puertas, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- Studie stoel: Laura Camprubí-Roca, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- Studie stoel: Mª Lluisa Torrent-Bertran, MD, Hospital Vall d'Hebron
- Studie stoel: Ana Palacios-González, Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
- Studie stoel: Tamara Biedermann-Villagra, MD, Hospital Vall d'Hebron
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2013
Primaire voltooiing (Werkelijk)
1 november 2014
Studie voltooiing (Werkelijk)
1 januari 2015
Studieregistratiedata
Eerst ingediend
11 november 2013
Eerst ingediend dat voldeed aan de QC-criteria
19 november 2013
Eerst geplaatst (Schatting)
25 november 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
16 juni 2015
Laatste update ingediend die voldeed aan QC-criteria
15 juni 2015
Laatst geverifieerd
1 juni 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CLBP-PT_ATR_274-2012
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