Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction (MBSR) for Chronic Low Back Pain

NCT00360802 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2009-05-28

No results posted yet for this study

Summary

The primary purpose of this study is to determine the effectiveness of two psychological techniques in chronic low back pain patients treated in hospital pain clinics. The techniques are: cognitive behavioral treatment and mindfulness based stress reduction (MBSR). This is a multiple site project in which patients come from 16 different pain clinics throughout Spain. The control group is formed by patients under usual medical treatment at pain clinics. The two intervention groups also receive usual medical treatment at pain clinics plus one psychological therapy treatment. The sample size is 330 subjects.

Conditions

  • Chronic Low Back Pain

Interventions

BEHAVIORAL

Cognitive Behavioral Treatment

Behavioral treatment to reduce pain in chronic back pain patients

BEHAVIORAL

Mindfulness Based Stress Reduction

Behavioral treatment to reduce pain in chronic back pain patients

Sponsors & Collaborators

  • Spanish Back Pain Research Network (REIDE)

    collaborator OTHER
  • Fondo de Investigacion Sanitaria

    collaborator OTHER
  • Universitat Autonoma de Barcelona

    collaborator OTHER
  • Kovacs Foundation

    lead OTHER

Principal Investigators

  • Francisco M. Kovacs, MD, PhD · Kovacs Foundation, Palma de Mallorca, 07012, Spain

  • Jenny Moix, PhD · Departamento de Psicología Básica, Universidad Autónoma de Barcelona, Bellaterra, Barcelona 08193, Spain

  • María José Martín · Hospital Mutua de Terrasa, Terrasa 08221, Spain

  • María Angeles Pastor · Hospital General y Universitario de Alicante, Alicante 03010, Spain

  • María Isabel Casado, PhD · Hospital 12 de Octubre, Madrid 28041, Soain

  • Carlos Peña, PhD · Hospital Universitario Marqués de Valdecilla, Santander 39008, Spain

  • Andrés Martín, BS · Hospital de Son Llatzer, Palma de Mallorca 07198, Spain

  • Gema Rodríguez · Hospital Severo Ochoa, Leganés, Madrid 28911, Spain

  • Francisco Javier Cano, PhD · Hospital Universitario Virgen del Rocío, Sevilla 41013, Spain

  • Milena Gobbo, BS · Fundación Hospital Alcorcón, Madrid 28922, Spain

  • Almudena Mateos, BS · Fundación Hospital Alcorcón, Madrid 28922, Spain

  • Carla Casals, BS · Hospital de Figueres, Figueres 17600, Spain

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-03-31
Completion
2009-05-31

Countries

  • Spain

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00360802 on ClinicalTrials.gov