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

Study Overview
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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.

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Treatment
* Behavioral: Mindfulness Based Stress Reduction


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT<br>Cognitive Behavioral Treatment | Behavioral: Cognitive Behavioral Treatment<br>* Behavioral treatment to reduce pain in chronic back pain patients<br>|
| Active Comparator: MBSR<br>Mindfulness Based Stress Reduction | Behavioral: Mindfulness Based Stress Reduction<br>* Behavioral treatment to reduce pain in chronic back pain patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of improvement in: anxiety, quality of life |  | immediately after therapy, at 3 months, and at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic low back pain, cognitive-behavioral therapy, Mindful Based Stress Reduction, pain clinics, anxiety, quality of life, chronic pain