Evaluating a Chronic Pain Treatment Program

Chronic Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861302
• Other study ID #: WSU094808B3E
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2009
• Last updated: June 18, 2012
• Start date: September 2008
• Est. completion date: November 2011

Study information

• Verified date: June 2012
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Musculoskeletal Pain
• Chronic Pain
• Musculoskeletal Pain

Intervention

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.

Locations

Country	Name	City	State
United States	St. John Providence Health System	Southfield	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory		baseline, post-treatment, 3- and 6-month follow-ups	No
Secondary	Center for Epidemiologic Studies--Depression Scale		baseline, post-treatment, 3- and 6-month follow-ups	No
Secondary	Satisfaction with Life Scale		baseline, post-treatment, 3- and 6-month follow-ups	No
Secondary	McGill Pain Questionnaire		baseline, post-treatment, 3- and 6-month follow-ups	No
Secondary	Impact of Events Scale-Revised		baseline, post-treatment, 3- and 6-month follow-ups	No
Secondary	Positive Affect Negative Affect Scale-Expanded Version		baseline, post-treatment, 3- and 6-month follow-ups	No