Mechanisms of Psychosocial Chronic Pain Treatments

Study Overview
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Brief Summary
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Psychosocial interventions are attractive options for treating chronic low back pain, and many approaches now have strong support for efficacy. However, few empirical data address whether psychosocial pain treatments work because of mechanisms specified by theory, and thus investigators know very little about HOW our treatments work. It may be that different treatments work via distinct pathways that are specific to a given treatment (single effect model), or it may be that different treatments work to the extent they all operate via key mechanisms that they share (additive effects model). Examination of specific and/or shared effects on outcomes of mechanisms will provide theoretical and empirical rationale for enhancing procedures and techniques most closely linked to strong outcomes and incorporating them into future interventions, while limiting the use of others that may be revealed as inert.

Official Title
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Mechanisms of Psychosocial Chronic Pain Treatments

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: cognitive therapy
* Behavioral: mindfulness training
* Behavioral: behavioral therapy
* Other: treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: significant daily chronic pain intensity (at least 4 on a 10-point scale; see below) and interference in performing daily activities due to pain (at least 3 on a 6-point scale; see below) for at least 6 months musculoskeletal pain of the low back and/or leg pain that may be related to history of degenerative disk disease, spinal stenosis, or disk herniation (radiculopathy subcategory), or muscular or ligamentous strain (chronic myofascial pain subcategory) age between 18 and 75 years. Exclusion Criteria: meet criteria for alcohol or substance abuse problems meet criteria for past or present psychotic or bipolar disorders inability to understand English well enough to complete questionnaires or to participate in therapy active suicidal ideation with intent pain is due to malignant conditions (eg, cancer, rheumatoid arthritis), migraine or tension headache, fibromyalgia or complex regional pain syndrome.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cognitive therapy<br>Cognitive therapy will be delivered to decrease pain interference | Behavioral: cognitive therapy<br> <br> Other: treatment as usual<br> <br> |
| Active Comparator: mindfulness training<br>Mindfulness training will be delivered to decrease pain interference | Behavioral: mindfulness training<br> <br> Other: treatment as usual<br> <br> |
| Active Comparator: behavior therapy<br>Behavior therapy will be delivered to decrease pain interference | Behavioral: behavioral therapy<br> <br> Other: treatment as usual<br> <br> |
| Active Comparator: treatment as usual<br>Subjects will engage in their usual care for low back pain. | Other: treatment as usual<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain interference | Pain interference will be assessed with Pain Interference Subscale items of the Multidimensional Pain Inventory | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity level | Activity level will be assessed with the General Activity subscale items of the Multidimensional Pain Inventory, and via actigraphy. | 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, psychosocial interventions, mechanisms