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Evaluating a Chronic Pain Treatment Program

This study has been completed.
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University
ClinicalTrials.gov Identifier:
NCT00861302
First received: March 12, 2009
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

This interventional study seeks to evaluate the overall outcomes of a novel, emotional awareness intervention for people with chronic musculoskeletal pain and determine which patients benefit the most from this intervention. The investigators also are evaluating the effects of brief emotional communication technique embedded in the pre-treatment assessment.


Condition Intervention Phase
Chronic Musculoskeletal Pain
 Behavioral: Mind-body emotional awareness program
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating Outcomes and Response Profiles of a Psychological Treatment for People With Chronic Pain

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Brief Pain Inventory [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Center for Epidemiologic Studies--Depression Scale [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Satisfaction with Life Scale [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • McGill Pain Questionnaire [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Impact of Events Scale-Revised [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Positive Affect Negative Affect Scale-Expanded Version [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: September 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
This is the only group in the study. It consists of patients with chronic musculoskeletal pain who are receiving the treatment program
 Behavioral: Mind-body emotional awareness program
This intervention, developed and offered by Dr. Howard Schubiner of St. John Providence Health System, consists of a single individual session with him, followed by four, classroom group sessions. The intervention includes expressive writing, mindfulness, and other techniques designed to enhance awareness and acceptance of the emotional factors underlying the chronic pain problem.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with chronic musculoskeletal pain, not accounted for by disease or tissue pathology, who are seeking or referred for this psychological treatment program

Exclusion Criteria:

  • Autoimmune diseases
  • Cancer pain
  • Illiterate
  • Cognitively impaired
  • Too medically ill
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861302

Locations
United States, Michigan
St. John Providence Health System
Southfield, Michigan, United States, 48075
Sponsors and Collaborators
Wayne State University
Blue Cross Blue Shield of Michigan Foundation
Investigators
Principal Investigator: Mark A Lumley, Ph.D. Wayne State University
  More Information

No publications provided

Responsible Party: Mark A. Lumley, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00861302     History of Changes
Other Study ID Numbers: WSU094808B3E
Study First Received: March 12, 2009
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013