Evaluating a Chronic Pain Treatment Program - Full Text View

Sponsors and Collaborators:	Wayne State University Blue Cross Blue Shield of Michigan
Information provided by:	Wayne State University
ClinicalTrials.gov Identifier:	NCT00861302

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Evaluating Outcomes and Response Profiles of a Psychological Treatment for People With Chronic Pain

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 ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment group: Experimental 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.

Arms

Assigned Interventions

Treatment group: Experimental

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

Contacts

Contact: Howard Schubiner, MD

248-849-4728

Howard.Schubiner@providence-stjohnhealth.org

Locations

United States, Michigan
St. John Providence Health System	Recruiting
Southfield, Michigan, United States, 48075
Contact: Howard Schubiner, MD 248-849-4728 Howard.Schubiner@providence-stjohnhealth.org
Principal Investigator: Howard Schubiner, MD

Sponsors and Collaborators

Wayne State University

Blue Cross Blue Shield of Michigan

Investigators

Principal Investigator:

Mark A Lumley, Ph.D.

Wayne State University

More Information

No publications provided

Responsible Party:	Department of Psychology, Wayne State University ( Mark A. Lumley, Ph.D., Professor )
Study ID Numbers:	WSU094808B3E
Study First Received:	March 12, 2009
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00861302 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on May 07, 2009