Comparative Mechanisms of Psychosocial Chronic Pain Treatments

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Behavioral: behavioral therapy; Behavioral: cognitive therapy; Behavioral: mindfulness training; Other: treatment as usual

• Registration Number: NCT02133976
• Lead Sponsor: Rush University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Study Start: 2014-06
• Primary Completion: 2018-09
• Study Completion: 2019-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 521

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cognitive therapy	treatment as usual	Cognitive therapy will be delivered to decrease pain interference
behavior therapy	behavioral therapy	Behavior therapy will be delivered to decrease pain interference
cognitive therapy	cognitive therapy	Cognitive therapy will be delivered to decrease pain interference
mindfulness training	mindfulness training	Mindfulness training will be delivered to decrease pain interference
behavior therapy	treatment as usual	Behavior therapy will be delivered to decrease pain interference
mindfulness training	treatment as usual	Mindfulness training will be delivered to decrease pain interference
treatment as usual	treatment as usual	Subjects will engage in their usual care for low back pain.

Primary Outcome Measures

Name	Time	Method
Pain interference	12 months	Pain interference will be assessed with Pain Interference Subscale items of the Multidimensional Pain Inventory

Secondary Outcome Measures

Name	Time	Method
Activity level	12 months	Activity level will be assessed with the General Activity subscale items of the Multidimensional Pain Inventory, and via actigraphy.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States