Comparative Mechanisms of Psychosocial Chronic Pain Treatments

Comparative Mechanisms (Mediators, Moderators) of Psychosocial Chronic Pain Treatments

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Other: treatment as usual; Behavioral: cognitive therapy; Behavioral: mindfulness training; Behavioral: behavioral therapy

• Study Type: Interventional
• Enrollment (Actual): 521
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Duke University; University of Alabama, Tuscaloosa
• Investigators: Principal Investigator: John W Burns, PhD, Rush University Medical Center

Publications and helpful links

General Publications

• Burns JW, Jensen MP, Thorn B, Lillis TA, Carmody J, Newman AK, Keefe F. Cognitive therapy, mindfulness-based stress reduction, and behavior therapy for the treatment of chronic pain: randomized controlled trial. Pain. 2022 Feb 1;163(2):376-389. doi: 10.1097/j.pain.0000000000002357.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: May 5, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimated): May 8, 2014

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: chronic low back pain; mechanisms; psychosocial interventions
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: 12101001