Evaluating a Chronic Pain Treatment Program

June 18, 2012 updated by: Mark A. Lumley, Wayne State University

Evaluating Outcomes and Response Profiles of a Psychological Treatment for People With Chronic Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Southfield, Michigan, United States, 48075
        • St. John Providence Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brief Pain Inventory
Time Frame: baseline, post-treatment, 3- and 6-month follow-ups
baseline, post-treatment, 3- and 6-month follow-ups

Secondary Outcome Measures

Outcome Measure
Time Frame
Center for Epidemiologic Studies--Depression Scale
Time Frame: baseline, post-treatment, 3- and 6-month follow-ups
baseline, post-treatment, 3- and 6-month follow-ups
Satisfaction with Life Scale
Time Frame: baseline, post-treatment, 3- and 6-month follow-ups
baseline, post-treatment, 3- and 6-month follow-ups
McGill Pain Questionnaire
Time Frame: baseline, post-treatment, 3- and 6-month follow-ups
baseline, post-treatment, 3- and 6-month follow-ups
Impact of Events Scale-Revised
Time Frame: baseline, post-treatment, 3- and 6-month follow-ups
baseline, post-treatment, 3- and 6-month follow-ups
Positive Affect Negative Affect Scale-Expanded Version
Time Frame: baseline, post-treatment, 3- and 6-month follow-ups
baseline, post-treatment, 3- and 6-month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wayne State University

Collaborators

Blue Cross Blue Shield of Michigan Foundation

Investigators

  • Principal Investigator: Mark A Lumley, Ph.D., Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

March 12, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimate)

March 13, 2009

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSU094808B3E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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