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

Kovacs Foundation1 site in 1 country330 target enrollmentMay 2006

ConditionsChronic Low Back Pain

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Chronic Low Back Pain
Sponsor: Kovacs Foundation
Enrollment: 330
Locations: 1
Primary Endpoint: Degree of improvement in: anxiety, quality of life
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

May 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kovacs Foundation

Eligibility 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.

Outcomes

Primary Outcomes

Degree of improvement in: anxiety, quality of life

Time Frame: immediately after therapy, at 3 months, and at 12 months

Secondary Outcomes

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)