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

Chronic Low Back Pain Clinical Trial

Official title:

The Effectiveness of Cognitive Behavioral Treatment and Mindfulness Based Stress Reduction for Chronic Low Back Pain Treated in Pain Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360802
• Other study ID #: FK-FIS-22
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2006
• Last updated: May 27, 2009
• Start date: May 2006
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Kovacs Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Back Pain Research Network (REIDE)Spain: Universidad Autónoma de Barcelona
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• Cognitive Behavioral Treatment
Behavioral treatment to reduce pain in chronic back pain patients
• Mindfulness Based Stress Reduction
Behavioral treatment to reduce pain in chronic back pain patients

Locations

Country	Name	City	State
Spain	Universidad Autónoma de Barcelona, Dept. Psicología Básica, Evolutiva y de la Educación	Bellaterra, Barcelona	Cataluña

Sponsors (4)

Lead Sponsor	Collaborator
Kovacs Foundation	Fondo de Investigacion Sanitaria, Spanish Back Pain Research Network (REIDE), Universitat Autonoma de Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Basler HD, Jäkle C, Kröner-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. — View Citation

Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001 Feb 1;344(5):363-70. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of improvement in: anxiety, quality of life		immediately after therapy, at 3 months, and at 12 months	No
Secondary	Degree of improvement in: pain, disability, catastrophizing, depression, anger, analgesic medication, satisfaction with treatment received		immediately after therapy, at 3 months, and at 12 months	No

External Links

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