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Mechanisms of Psychosocial Chronic Pain Treatments

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

cognitive therapy

mindfulness training

behavioral therapy

treatment as usual

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring chronic low back pain, psychosocial interventions, mechanisms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

cognitive therapy

mindfulness training

behavior therapy

treatment as usual

Arm Description

Cognitive therapy will be delivered to decrease pain interference

Mindfulness training will be delivered to decrease pain interference

Behavior therapy will be delivered to decrease pain interference

Subjects will engage in their usual care for low back pain.

Outcomes

Primary Outcome Measures

Pain interference

Pain interference will be assessed with Pain Interference Subscale items of the Multidimensional Pain Inventory

Secondary Outcome Measures

Activity level

Activity level will be assessed with the General Activity subscale items of the Multidimensional Pain Inventory, and via actigraphy.

Full Information

NCT ID

NCT02133976

First Posted

May 5, 2014

Last Updated

September 4, 2019

Sponsor

Rush University Medical Center

Collaborators

Duke University, University of Alabama, Tuscaloosa

1. Study Identification

Unique Protocol Identification Number

NCT02133976

Brief Title

Mechanisms of Psychosocial Chronic Pain Treatments

Official Title

Mechanisms of Psychosocial Chronic Pain Treatments

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

June 2014 (Actual)

Primary Completion Date

September 2018 (Actual)

Study Completion Date

July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rush University Medical Center

Collaborators

Duke University, University of Alabama, Tuscaloosa

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain

Keywords

chronic low back pain, psychosocial interventions, mechanisms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

521 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cognitive therapy

Arm Type

Active Comparator

Arm Description

Cognitive therapy will be delivered to decrease pain interference

Arm Title

mindfulness training

Arm Type

Active Comparator

Arm Description

Mindfulness training will be delivered to decrease pain interference

Arm Title

behavior therapy

Arm Type

Active Comparator

Arm Description

Behavior therapy will be delivered to decrease pain interference

Arm Title

treatment as usual

Arm Type

Active Comparator

Arm Description

Subjects will engage in their usual care for low back pain.

Intervention Type

Behavioral

Intervention Name(s)

cognitive therapy

Intervention Type

Behavioral

Intervention Name(s)

mindfulness training

Intervention Type

Behavioral

Intervention Name(s)

behavioral therapy

Intervention Type

Other

Intervention Name(s)

treatment as usual

Primary Outcome Measure Information:

Title

Pain interference

Description

Pain interference will be assessed with Pain Interference Subscale items of the Multidimensional Pain Inventory

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Activity level

Description

Activity level will be assessed with the General Activity subscale items of the Multidimensional Pain Inventory, and via actigraphy.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John W Burns, PhD

Organizational Affiliation

Rush University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34074945

Citation

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.

Results Reference

derived

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Mechanisms of Psychosocial Chronic Pain Treatments

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