Clinical trial NCT01993355: Chronic Low Back Pain: A Multidisciplinary Approach
Official title: A Multidisciplinary Approach to Treat and Rehabilitate Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: non-specific chronic low back pain,
health-related quality of life,
physioterapy,
sophrology,
cognitive-behavioral therapy,
motivational interviewing
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The SF-12v2 Health Status Questionnaire (change is being assessed)
timeFrame: Baseline, 6 and 12 months
Secondary outcomes:
measure: VAS for Self-perceived Pain
timeFrame: Baseline, 6 and 12 months
measure: Oswestry-15 Disability Index
timeFrame: Baseline, 6 and 12 months
Other outcomes:
measure: LISAT-8
timeFrame: Baseline, 6 and 12 months
measure: STAI
timeFrame: Baseline, 6 and 12 months
measure: BDI-13
timeFrame: Baseline, 6 and 12 months
measure: PSQI
timeFrame: Baseline, 6 and 12 months
measure: CAD
timeFrame: Baseline and 12 months
measure: TAS-20
timeFrame: Baseline and 12 months
measure: PSS-14
timeFrame: Baseline and 12 months
measure: DUKE-11
timeFrame: Baseline and 12 months
measure: VAS for patient satisfaction with treatment received
timeFrame: Baseline, 6 and 12 months
measure: Medical and demographics
timeFrame: Baseline
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron
Study officials:
affiliation: Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron
name: Carmina Castellano-Tejedor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d'Hebron
name: Elisa Barnola-Serra, MD
role: STUDY_DIRECTOR
affiliation: Hospital Vall d'Hebron
name: Gemma Costa-Requena, MsC
role: STUDY_CHAIR
affiliation: Hospital Vall d'Hebron
name: Pilar Lusilla-Palacios, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
name: Alex Ginés-Puertas
role: STUDY_CHAIR
affiliation: Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
name: Laura Camprubí-Roca
role: STUDY_CHAIR
affiliation: Hospital Vall d'Hebron
name: Mª Lluisa Torrent-Bertran, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili
name: Ana Palacios-González
role: STUDY_CHAIR
affiliation: Hospital Vall d'Hebron
name: Tamara Biedermann-Villagra, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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
citation: 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.