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OpenTrials
Completed

NCT Number: NCT02133976

Comparative Mechanisms 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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cognitive therapy

Behavioral

Mindfulness Training

Behavioral

Behavioral therapy

Behavioral

Treatment as Usual

Other

Primary outcomes

  1. Pain interference

    Time frame: 12 months

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

Secondary outcomes

  1. Activity level

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Duke University
  • University of Alabama, Tuscaloosa

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
May 8, 2014
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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