We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00360802
First Posted: August 7, 2006
Last Update Posted: May 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Spanish Back Pain Research Network (REIDE)
Fondo de Investigacion Sanitaria
Universitat Autonoma de Barcelona
Information provided by:
Kovacs Foundation
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
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
First Submitted: August 4, 2006
First Posted: August 7, 2006
Last Update Posted: May 28, 2009
Last Verified: May 2009

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