University of Michigan / Wayne State Chronic Pain Study

Chronic Musculoskeletal Pain Clinical Trial

Official title:

Openness to Cognitive Approach of Nonspecific Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391661
• Other study ID #: HUM00121358
• Status: Completed
• Phase: N/A
• Start date: December 10, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: July 2019
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to determine if a brief educational program can alter the attitudes and knowledge of individuals with chronic back pain, which is likely to be non-structural in nature.

Individuals will be randomly assigned to an experimental condition (performs written educational and emotional awareness exercises) or a control condition (completes a general health activities questionnaire). Comparisons will be made to assess the degree of centralized pain features and functional improvements at 1-month follow-up. A 10-month follow-up as a secondary endpoint is also planned.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 28, 2019
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English-speaking adults ages 18 years or older with internet access who are referred to the University of Michigan Health Service Physical Medicine and Rehabilitation Spine Program identified the physician with chronic nonspecific back pain (longer than 3 months) or fibromyalgia. Degenerative changes seen on imaging are considered nonspecific. Alternatively, enrolled in the University of Michigan Health Research Volunteer Pool with a profile that includes chronic low back pain or fibromyalgia.

Exclusion Criteria:

• Any signs of a serious underlying condition (cancer, infection, cauda equine), spinal stenosis or radiculopathy, or other specific spinal cause (vertebral compression fracture or ankylosing spondylitis). Those patients who are being considered for an interventional spine procedures or surgical consults would not be included in this study.

• Individuals receiving or applying for compensation or disability, the inability to provide written informed consent, severe physical impairment (e.g. blindness, deafness), co-morbid medical condition limiting function (e.g. malignant cancer), the use of illicit drug use, or a psychiatric condition that would limit judgment.

Related Conditions & MeSH terms

• Chronic Musculoskeletal Pain
• Chronic Pain
• Musculoskeletal Pain

Intervention

Behavioral:
• Pain neuroscience education patient exercise
Patients complete a 15 to 20-minute on-line exercise that inquires about 5 domains: the degree of central sensitization symptoms, catastrophizing and kinesiophobia, personality factors, stressors that triggered or exacerbated the pain, and adverse childhood experiences.
• Health behavior control intervention
Patients engage in a 15 to 20-minute on-line exercise examining their health behaviors in five domains: exercise, sleep, diet, hygiene, and social connections.

Locations

Country	Name	City	State
United States	University of Michigan Physical Medicine and Rehabilitation Department	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory	Self-reported pain and dysfunction	Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary	Patient-Reported Outcomes Measurement Information System: Depression short form 8b	Self-reported depression	Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary	Patient-Reported Outcomes Measurement Information System: Anxiety short form 8a	Self-reported anxiety	Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary	Patient-Reported Outcomes Measurement Information System: Anger short form 5a	Self-reported anger	Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary	Pain attributions questionnaires	Two self-report questionnaires were developed to assess psychological and brain influences on pain. The 4-item psychological attribution scale assesses patients' beliefs that their thoughts and feelings and psychological therapy impacts pain, and the 3-item brain attribution scale assesses patient's beliefs that their pain is brain-based. Mean scores will be computed for both scales separately (0-4; higher scores indicating greater belief that pain is a brain-related [brain attribution] construct and that pain is affected by thoughts, feelings, and psychological interventions [psychological attribution])	Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary	Pain Stages of Change Questionnaire	The Pain Stages of Change questionnaire (Kerns, Rosenberg, Jamison, Caudill, & Haythornthwaite, 1997): an overall readiness score will be calculated using mean scores of the four subscales. Readiness is the sum of patient mean ratings for contemplation (C; 1-5), action (A; 1-5), and maintenance (M; 1-5), minus the mean score for precontemplation (PC; 1-5): C + A + M - PC = Readiness. Higher scores indicate greater readiness.	Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary	Pain Catastrophizing Scale	Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)	Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary	Tampa Scale for Kinesiophobia	The Tampa Kinesiophobia Scale (Miller, Kori, &Todd, 1991): A mean score of the 11 items will be computed (1-4, higher scores indicating greater kinesiophobia)	Change from baseline to 1-Month follow-up (with secondary 10-month follow-up)
Secondary	Satisfaction with Life Scale	The Satisfaction with Life Scale (Emmons, Larsen, & Griffin, 1985): A mean score of the 5 items will be computed (1-7, higher scores indicating greater life satisfaction)	Change from baseline to 1-month follow-up (with secondary 10-month follow-up)