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

This study has been completed.
Sponsor:
Collaborators:
Spanish Back Pain Research Network (REIDE)
Fondo de Investigacion Sanitaria
Universitat Autonoma de Barcelona
Information provided by:
Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00360802
First received: August 4, 2006
Last updated: May 27, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Chronic Low Back Pain
Behavioral: Cognitive Behavioral Treatment
Behavioral: Mindfulness Based Stress Reduction
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction for Chronic Low Back Pain Treated in Pain Clinics

Resource links provided by NLM:


Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:
  • Degree of improvement in: anxiety, quality of life [ Time Frame: immediately after therapy, at 3 months, and at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of improvement in: pain, disability, catastrophizing, depression, anger, analgesic medication, satisfaction with treatment received [ Time Frame: immediately after therapy, at 3 months, and at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: May 2006
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CBT
Cognitive Behavioral Treatment
Behavioral: Cognitive Behavioral Treatment
Behavioral treatment to reduce pain in chronic back pain patients
Active Comparator: MBSR
Mindfulness Based Stress Reduction
Behavioral: Mindfulness Based Stress Reduction
Behavioral treatment to reduce pain in chronic back pain patients

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic low back pain and failed back surgery patients
  • With or without referred or radiated pain
  • Who are between 18 and 70 years of age (inclusive)

Exclusion Criteria:

  • Patients with red flags for systemic disease or criteria for surgery
  • With intolerable intensity of pain despite 6 weeks or more of non-surgical treatment
  • With pain that appears only on walking and disappears with sitting, persists after 6 months of conservative treatment, and is a possible spinal stenosis
  • Under psychological or psychiatric treatment
  • Unable to fill out the questionnaires
  • Have received cognitive behavioral treatment in the past
  • Have ongoing work litigation or are in the process of obtaining permanent disability.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360802

Locations
Spain
Universidad Autónoma de Barcelona, Dept. Psicología Básica, Evolutiva y de la Educación
Bellaterra, Barcelona, Cataluña, Spain, 08193
Sponsors and Collaborators
Kovacs Foundation
Spanish Back Pain Research Network (REIDE)
Fondo de Investigacion Sanitaria
Universitat Autonoma de Barcelona
Investigators
Study Chair: Francisco M. Kovacs, MD, PhD Kovacs Foundation, Palma de Mallorca, 07012, Spain
Principal Investigator: Jenny Moix, PhD Departamento de Psicología Básica, Universidad Autónoma de Barcelona, Bellaterra, Barcelona 08193, Spain
Study Director: María José Martín Hospital Mutua de Terrasa, Terrasa 08221, Spain
Study Director: María Angeles Pastor Hospital General y Universitario de Alicante, Alicante 03010, Spain
Study Director: María Isabel Casado, PhD Hospital 12 de Octubre, Madrid 28041, Soain
Study Director: Carlos Peña, PhD Hospital Universitario Marqués de Valdecilla, Santander 39008, Spain
Study Director: Andrés Martín, BS Hospital de Son Llatzer, Palma de Mallorca 07198, Spain
Study Director: Gema Rodríguez Hospital Severo Ochoa, Leganés, Madrid 28911, Spain
Study Director: Francisco Javier Cano, PhD Hospital Universitario Virgen del Rocío, Sevilla 41013, Spain
Study Director: Milena Gobbo, BS Fundación Hospital Alcorcón, Madrid 28922, Spain
Study Director: Almudena Mateos, BS Fundación Hospital Alcorcón, Madrid 28922, Spain
Study Director: Carla Casals, BS Hospital de Figueres, Figueres 17600, Spain
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jenny Moix, Professor, Universidad Autónoma de Barcelona
ClinicalTrials.gov Identifier: NCT00360802     History of Changes
Other Study ID Numbers: FK-FIS-22
Study First Received: August 4, 2006
Last Updated: May 27, 2009
Health Authority: Spain: Spanish Back Pain Research Network (REIDE)
Spain: Universidad Autónoma de Barcelona

Keywords provided by Kovacs Foundation:
chronic low back pain
cognitive-behavioral therapy
Mindful Based Stress Reduction
pain clinics
anxiety
quality of life
chronic pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014