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Evaluating a Chronic Pain Treatment Program

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ClinicalTrials.gov Identifier: NCT00861302
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : June 19, 2012
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Mark A. Lumley, Wayne State University

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Musculoskeletal Pain Behavioral: Mind-body emotional awareness program Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating Outcomes and Response Profiles of a Psychological Treatment for People With Chronic Pain
Study Start Date : September 2008
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Brief Pain Inventory [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ]

Secondary Outcome Measures :
  1. Center for Epidemiologic Studies--Depression Scale [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ]
  2. Satisfaction with Life Scale [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ]
  3. McGill Pain Questionnaire [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ]
  4. Impact of Events Scale-Revised [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ]
  5. Positive Affect Negative Affect Scale-Expanded Version [ Time Frame: baseline, post-treatment, 3- and 6-month follow-ups ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark A. Lumley, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT00861302     History of Changes
Other Study ID Numbers: WSU094808B3E
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Chronic Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases