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

Phase 2

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Behavioral: Cognitive Behavioral Treatment; Behavioral: Mindfulness Based Stress Reduction

• Registration Number: NCT00360802
• Lead Sponsor: Kovacs Foundation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-08-04
• Study First Submitted QC: 2006-08-04
• Study First Posted: 2006-08-07
• Primary Completion: 2009-03
• Status Verified: 2009-05
• Study Completion: 2009-05
• Last Update Submitted: 2009-05-27
• Last Update Posted: 2009-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT	Cognitive Behavioral Treatment	Cognitive Behavioral Treatment
MBSR	Mindfulness Based Stress Reduction	Mindfulness Based Stress Reduction

Primary Outcome Measures

Name	Time	Method
Degree of improvement in: anxiety, quality of life	immediately after therapy, at 3 months, and at 12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universidad Autónoma de Barcelona, Dept. Psicología Básica, Evolutiva y de la Educación; 🇪🇸 Bellaterra, Barcelona, Cataluña, Spain