Comparative Mechanisms of Psychosocial Chronic Pain Treatments

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02133976
• Other study ID #: 12101001
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: July 2019

Study information

• Verified date: May 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: July 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Chronic Pain
• Low Back Pain

Intervention

Behavioral:
• cognitive therapy

• mindfulness training

• behavioral therapy

Other:
• treatment as usual

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	Duke University, University of Alabama, Tuscaloosa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain interference	Pain interference will be assessed with Pain Interference Subscale items of the Multidimensional Pain Inventory	12 months
Secondary	Activity level	Activity level will be assessed with the General Activity subscale items of the Multidimensional Pain Inventory, and via actigraphy.	12 months