Chronic Low Back Pain: A Multidisciplinary Approach

NCT01993355 | Completed

• 1 other identifier: CLBP-PT_ATR_274-2012
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

non-specific chronic low back pain,; health-related quality of life,; physioterapy,; sophrology,; cognitive-behavioral therapy,; motivational interviewing

Outcome Measures

Primary Outcomes (1)

• The SF-12v2 Health Status Questionnaire (change is being assessed)

  The SF-12 measures health-related quality of life including items from various domains both physical and psychological.

  Baseline, 6 and 12 months

Secondary Outcomes (2)

• VAS for Self-perceived Pain

  Baseline, 6 and 12 months

• Oswestry-15 Disability Index

  Baseline, 6 and 12 months

Other Outcomes (10)

• LISAT-8

  Baseline, 6 and 12 months

• STAI

  Baseline, 6 and 12 months

• BDI-13

  Baseline, 6 and 12 months

Study Arms (3)

TAU

ACTIVE COMPARATOR

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

Other: Physiotherapy

Intervention 1 Relaxation techniques-sophrology

EXPERIMENTAL

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

Other: Physiotherapy; Other: Intervention 1

Intervention 2 Cognitive-behavioral therapy

EXPERIMENTAL

Intervention group 2: TAU + cognitive-behavioral therapy.

Other: Physiotherapy; Behavioral: Intervention 2

Interventions

Physiotherapy 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.

Also known as: Treatment as usual (TAU)

Intervention 1 Relaxation techniques-sophrology; Intervention 2 Cognitive-behavioral therapy; TAU

Intervention 1 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.

Also known as: Relaxation techniques-sophrology

Intervention 1 Relaxation techniques-sophrology

Intervention 2 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.

Also known as: CBT

Intervention 2 Cognitive-behavioral therapy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

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

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (3)

• 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.

  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

  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.

  RESULT

MeSH Terms

Conditions

Chronic Pain

Interventions

Physical Therapy Modalities; Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation

Study Officials

• Carmina Castellano-Tejedor, PhD

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

  PRINCIPAL INVESTIGATOR

• Elisa Barnola-Serra, MD

  Hospital Vall d'Hebron

  STUDY DIRECTOR

• Gemma Costa-Requena, MsC

  Hospital Vall d'Hebron

  STUDY CHAIR

• Pilar Lusilla-Palacios, MD, PhD

  Hospital Vall d'Hebron

  STUDY CHAIR

• Alex Ginés-Puertas

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

  STUDY CHAIR

• Laura Camprubí-Roca

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

  STUDY CHAIR

• Mª Lluisa Torrent-Bertran, MD

  Hospital Vall d'Hebron

  STUDY CHAIR

• Ana Palacios-González

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

  STUDY CHAIR

• Tamara Biedermann-Villagra, MD

  Hospital Vall d'Hebron

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2013
• First Posted: November 25, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

ES (1)