Chronic Low Back Pain: A Multidisciplinary Approach

NCT ID: NCT01993355

Last Updated: 2015-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-01-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

TAU

Control group. Treatment as usual (TAU): Physiotherapy program for CLBP.

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

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.

Intervention 1 Relaxation techniques-sophrology

Intervention group 1: TAU + relaxation techniques-sophrology program.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

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.

Intervention 1

Intervention Type: OTHER

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.

Intervention 2 Cognitive-behavioral therapy

Intervention group 2: TAU + cognitive-behavioral therapy.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

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.

Intervention 2

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Treatment as usual (TAU); Relaxation techniques-sophrology; CBT

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carmina Castellano-Tejedor, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'Hebron - Institut de Recerca Vall d'Hebron

Elisa Barnola-Serra, MD

Role: STUDY_DIRECTOR

Hospital Vall d'Hebron

Gemma Costa-Requena, MsC

Role: STUDY_CHAIR

Hospital Vall d'Hebron

Pilar Lusilla-Palacios, MD, PhD

Role: STUDY_CHAIR

Hospital Vall d'Hebron

Alex Ginés-Puertas

Role: STUDY_CHAIR

Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili

Laura Camprubí-Roca

Role: STUDY_CHAIR

Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili

Mª Lluisa Torrent-Bertran, MD

Role: STUDY_CHAIR

Hospital Vall d'Hebron

Ana Palacios-González

Role: STUDY_CHAIR

Hospital Universitario Vall d'Hebron - Parc Sanitari Pere i Virgili

Tamara Biedermann-Villagra, MD

Role: STUDY_CHAIR

Hospital Vall d'Hebron

Locations

Hospital Universitari Vall d'Hebron Institut de Recerca Vall d'Hebron

Barcelona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

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

Reference Type: RESULT

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.

Reference Type: RESULT

Other Identifiers

CLBP-PT_ATR_274-2012

Identifier Type: -

Identifier Source: org_study_id