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Comparative Mechanisms of Psychosocial Chronic Pain Treatments

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02133976
Enrollment
521
Registered
2014-05-08
Start date
2014-06-30
Completion date
2019-07-31
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

chronic low back pain, psychosocial interventions, mechanisms

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.

Interventions

BEHAVIORALcognitive therapy
BEHAVIORALmindfulness training
BEHAVIORALbehavioral therapy
OTHERtreatment as usual

Sponsors

Duke University
CollaboratorOTHER
University of Alabama, Tuscaloosa
CollaboratorOTHER
Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain interference12 monthsPain interference will be assessed with Pain Interference Subscale items of the Multidimensional Pain Inventory

Secondary

MeasureTime frameDescription
Activity level12 monthsActivity level will be assessed with the General Activity subscale items of the Multidimensional Pain Inventory, and via actigraphy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026