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Evaluating a Chronic Pain Treatment Program

Primary Purpose

Chronic Musculoskeletal Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mind-body emotional awareness program
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Musculoskeletal Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. John Providence Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

This is the only group in the study. It consists of patients with chronic musculoskeletal pain who are receiving the treatment program

Outcomes

Primary Outcome Measures

Brief Pain Inventory

Secondary Outcome Measures

Center for Epidemiologic Studies--Depression Scale
Satisfaction with Life Scale
McGill Pain Questionnaire
Impact of Events Scale-Revised
Positive Affect Negative Affect Scale-Expanded Version

Full Information

First Posted
March 12, 2009
Last Updated
June 18, 2012
Sponsor
Wayne State University
Collaborators
Blue Cross Blue Shield of Michigan Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00861302
Brief Title
Evaluating a Chronic Pain Treatment Program
Official Title
Evaluating Outcomes and Response Profiles of a Psychological Treatment for People With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
Collaborators
Blue Cross Blue Shield of Michigan Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Musculoskeletal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
This is the only group in the study. It consists of patients with chronic musculoskeletal pain who are receiving the treatment program
Intervention Type
Behavioral
Intervention Name(s)
Mind-body emotional awareness program
Intervention Description
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 Measure Information:
Title
Brief Pain Inventory
Time Frame
baseline, post-treatment, 3- and 6-month follow-ups
Secondary Outcome Measure Information:
Title
Center for Epidemiologic Studies--Depression Scale
Time Frame
baseline, post-treatment, 3- and 6-month follow-ups
Title
Satisfaction with Life Scale
Time Frame
baseline, post-treatment, 3- and 6-month follow-ups
Title
McGill Pain Questionnaire
Time Frame
baseline, post-treatment, 3- and 6-month follow-ups
Title
Impact of Events Scale-Revised
Time Frame
baseline, post-treatment, 3- and 6-month follow-ups
Title
Positive Affect Negative Affect Scale-Expanded Version
Time Frame
baseline, post-treatment, 3- and 6-month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Lumley, Ph.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. John Providence Health System
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26800632
Citation
Burger AJ, Lumley MA, Carty JN, Latsch DV, Thakur ER, Hyde-Nolan ME, Hijazi AM, Schubiner H. The effects of a novel psychological attribution and emotional awareness and expression therapy for chronic musculoskeletal pain: A preliminary, uncontrolled trial. J Psychosom Res. 2016 Feb;81:1-8. doi: 10.1016/j.jpsychores.2015.12.003. Epub 2015 Dec 11.
Results Reference
derived

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Evaluating a Chronic Pain Treatment Program

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