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

NCT ID: NCT00360802

Last Updated: 2009-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CBT

Cognitive Behavioral Treatment

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Treatment

Intervention Type BEHAVIORAL

Behavioral treatment to reduce pain in chronic back pain patients

MBSR

Mindfulness Based Stress Reduction

Group Type ACTIVE_COMPARATOR

Mindfulness Based Stress Reduction

Intervention Type BEHAVIORAL

Behavioral treatment to reduce pain in chronic back pain patients

Interventions

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Cognitive Behavioral Treatment

Behavioral treatment to reduce pain in chronic back pain patients

Intervention Type BEHAVIORAL

Mindfulness Based Stress Reduction

Behavioral treatment to reduce pain in chronic back pain patients

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Back Pain Research Network (REIDE)

OTHER

Sponsor Role collaborator

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role collaborator

Universitat Autonoma de Barcelona

OTHER

Sponsor Role collaborator

Kovacs Foundation

OTHER

Sponsor Role lead

Responsible Party

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Universidad Autónoma de Barcelona

Principal Investigators

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Francisco M. Kovacs, MD, PhD

Role: STUDY_CHAIR

Kovacs Foundation, Palma de Mallorca, 07012, Spain

Jenny Moix, PhD

Role: PRINCIPAL_INVESTIGATOR

Departamento de Psicología Básica, Universidad Autónoma de Barcelona, Bellaterra, Barcelona 08193, Spain

María José Martín

Role: STUDY_DIRECTOR

Hospital Mutua de Terrasa, Terrasa 08221, Spain

María Angeles Pastor

Role: STUDY_DIRECTOR

Hospital General y Universitario de Alicante, Alicante 03010, Spain

María Isabel Casado, PhD

Role: STUDY_DIRECTOR

Hospital 12 de Octubre, Madrid 28041, Soain

Carlos Peña, PhD

Role: STUDY_DIRECTOR

Hospital Universitario Marqués de Valdecilla, Santander 39008, Spain

Andrés Martín, BS

Role: STUDY_DIRECTOR

Hospital de Son Llatzer, Palma de Mallorca 07198, Spain

Gema Rodríguez

Role: STUDY_DIRECTOR

Hospital Severo Ochoa, Leganés, Madrid 28911, Spain

Francisco Javier Cano, PhD

Role: STUDY_DIRECTOR

Hospital Universitario Virgen del Rocío, Sevilla 41013, Spain

Milena Gobbo, BS

Role: STUDY_DIRECTOR

Fundación Hospital Alcorcón, Madrid 28922, Spain

Almudena Mateos, BS

Role: STUDY_DIRECTOR

Fundación Hospital Alcorcón, Madrid 28922, Spain

Carla Casals, BS

Role: STUDY_DIRECTOR

Hospital de Figueres, Figueres 17600, Spain

Locations

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Universidad Autónoma de Barcelona, Dept. Psicología Básica, Evolutiva y de la Educación

Bellaterra, Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

References

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Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. doi: 10.1056/NEJM200102013440508. No abstract available.

Reference Type BACKGROUND
PMID: 11172169 (View on PubMed)

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 (Phila Pa 1976). 2000 Oct 15;25(20):2688-99. doi: 10.1097/00007632-200010150-00024.

Reference Type BACKGROUND
PMID: 11034658 (View on PubMed)

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. doi: 10.1016/s0738-3991(97)00996-8.

Reference Type BACKGROUND
PMID: 9216352 (View on PubMed)

Moix J, Kovacs FM, Martin A, Plana MN, Royuela A; Spanish Back Pain Research Network. Catastrophizing, state anxiety, anger, and depressive symptoms do not correlate with disability when variations of trait anxiety are taken into account. a study of chronic low back pain patients treated in Spanish pain units [NCT00360802]. Pain Med. 2011 Jul;12(7):1008-17. doi: 10.1111/j.1526-4637.2011.01155.x. Epub 2011 Jun 13.

Reference Type DERIVED
PMID: 21668743 (View on PubMed)

Related Links

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http://www.reide.org

Spanish Back Pain Research Network site that describes objectives and projects of its members

Other Identifiers

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FK-FIS-22

Identifier Type: -

Identifier Source: org_study_id

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