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

Sponsors and Collaborators:	Kovacs Foundation Spanish Back Pain Research Network (REIDE) Fondo de Investigacion Sanitaria Universidad Autónoma de Barcelona
Information provided by:	Kovacs Foundation
ClinicalTrials.gov Identifier:	NCT00360802

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 II

MedlinePlus related topics: Anxiety Back Pain

U.S. FDA Resources

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

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
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CBT: Active Comparator Cognitive Behavioral Treatment	Behavioral: Cognitive Behavioral Treatment Behavioral treatment to reduce pain in chronic back pain patients
MBSR: Active Comparator 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

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

Contacts

Contact: Francisco M. Kovacs, MD, PhD	+34 971 720809	kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH	+34 91 3440244	mtgildelreal@kovacs.org

Locations

Spain, Cataluña
Universidad Autónoma de Barcelona, Dept. Psicología Básica, Evolutiva y de la Educación	Recruiting
Bellaterra, Barcelona, Cataluña, Spain, 08193
Contact: Jenny Moix, PhD +34 93 5813176 jenny.moix@uab.es
Contact: María Teresa Gil del Real, MPH +34 91 3440244 mtgildelreal@kovacs.org
Principal Investigator: Jenny Moix, PhD
Principal Investigator: María José Martín
Principal Investigator: María Angeles Pastor
Principal Investigator: María Isabel Casado, PhD
Principal Investigator: Carlos Peña, PhD
Principal Investigator: Andrés Martín, BS
Principal Investigator: Gema Rodríguez
Principal Investigator: Francisco Javier Cano, PhD
Principal Investigator: Milena Gobbo, BS
Principal Investigator: Almudena Mateos, BS
Principal Investigator: Carla Casals, BS

Sponsors and Collaborators

Kovacs Foundation

Spanish Back Pain Research Network (REIDE)

Fondo de Investigacion Sanitaria

Universidad Autónoma 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

Spanish Back Pain Research Network site that describes objectives and projects of its members This link exits the ClinicalTrials.gov site

Publications:

Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. Review. No abstract available.

van Tulder MW, Ostelo R, Vlaeyen JW, Linton SJ, Morley SJ, Assendelft WJ. Behavioral treatment for chronic low back pain: a systematic review within the framework of the Cochrane Back Review Group. Spine. 2000 Oct 15;25(20):2688-99. Review.

Basler HD, Jakle C, Kroner-Herwig B. Incorporation of cognitive-behavioral treatment into the medical care of chronic low back patients: a controlled randomized study in German pain treatment centers. Patient Educ Couns. 1997 Jun;31(2):113-24.

Responsible Party:	Universidad Autónoma de Barcelona ( Jenny Moix, Professor )
Study ID Numbers:	FK-FIS-22
Study First Received:	August 4, 2006
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00360802
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

Study placed in the following topic categories:

Signs and Symptoms
Quality of Life
Neurologic Manifestations
Stress

Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009