Clinical trial NCT02133976: Comparative Mechanisms of Psychosocial Chronic Pain Treatments
Official title: Comparative Mechanisms (Mediators, Moderators) of Psychosocial Chronic Pain Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: chronic low back pain
psychosocial interventions
mechanisms
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Duke University
name: University of Alabama, Tuscaloosa
First posted: 2014-05-08
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain interference
timeFrame: 12 months
Secondary outcomes:
measure: Activity level
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: John W Burns, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.