An interventional study of Chronic Pain Self-Management Program (CPSMP) in Chronic Pain, sponsored by West Virginia University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-12.
Sponsored by West Virginia University · Not applicable, Interventional, and Other
Chronic pain (CP) affects 1 in 3 US adults and costs up to $635 billion annually in medical costs and lost work productivity. Use of opioid medications for CP has risen in the US, and opioid overdose deaths have quadrupled, yet with no overall change in pain. Although one-third of US adults have CP, there is a lack of affordable, non-pharmacological, evidence-based, community-delivered interventions for people with CP.
One program, the Chronic Pain Self-Management Program (CPSMP), provides short-term improvements in pain but its long-term effects have not been evaluated. This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia (WV). The objectives of this community-engaged, randomized, wait-list controlled study are to: 1) determine the short- (26 weeks) and long-term (52 weeks) effectiveness of the 6-week CPSMP in adults with CP in WV; 2) evaluate the Reach (number of participants, completers), Effectiveness (outcomes), Adoption (number of sites, leaders, trainings), Implementation (fidelity), and Maintenance (satisfaction, continuation) of CPSMP using the RE-AIM Framework; and 3) disseminate the results to key stakeholders including evidence-based organizations, public health practitioners/researchers, and healthcare providers.
The study will enroll 240 participants in 24 workshops at 12 community-based sites in 2 counties in WV, Greenbrier (rural) and Wood (urban). Participants will attend free, 2.5-hour weekly sessions for 6 weeks. Self-reported, performance-based, and physiological data will be collected at baseline and 26, and 52 weeks after the start of the intervention. The primary outcomes are pain (severity, quality, interference, medication use), mental health (mood, anxiety, catastrophizing), function (self-efficacy, coping, health-related quality of life, sleep, fatigue, communication, physical activity), healthcare utilization, missed work days, and gait speed.
Chronic pain (CP) affects 1 in 3 US adults and costs up to $635 billion annually in medical costs and lost work productivity. The impact of CP is worse in people with both CP and comorbid chronic diseases such as arthritis, diabetes, and heart disease. Use of opioid medications for CP has risen in the US, and opioid overdose deaths have quadrupled, yet with no overall change in pain. Although one-third of US adults have CP, there is a lack of affordable, non-pharmacological, evidence-based, community-delivered interventions for people with CP. Thus, there is a vital need to rigorously test more interventions that can be brought to scale and widely disseminated in the US.
One program, the Chronic Pain Self-Management Program (CPSMP), provides short-term improvements in pain but its long-term effects have not been evaluated. This study will examine the long-term effects of CPSMP in the medically underserved state of West Virginia (WV). With one of the worst health profiles in the US, WV has the highest rates of arthritis, diabetes, heart disease, and drug overdose deaths, and therefore has a compelling need for the CPSMP. The objectives of this community-engaged, randomized, wait-list controlled study are to: 1) determine the short- (26 weeks) and long-term (52 weeks) effectiveness of the 6-week CPSMP in adults with CP in WV; 2) evaluate the Reach (number of participants, completers), Effectiveness (outcomes), Adoption (number of sites, leaders, trainings), Implementation (fidelity), and Maintenance (satisfaction, continuation) of CPSMP using the RE-AIM Framework; and 3) disseminate the results to key stakeholders including evidence-based organizations, public health practitioners/researchers, and healthcare providers.
The study will enroll 240 participants in 24 workshops at 12 community-based sites in 2 counties in WV, Greenbrier (rural) and Wood (urban). Participants will attend free, 2.5-hour weekly sessions for 6 weeks. Two trained leaders will facilitate group discussions on managing pain, emotions, depression, fatigue, and sleep; proper exercise, nutrition, and medication use; weight management; strategies for effective communication with healthcare professionals; evaluating treatments; and pacing/planning. Self-reported, performance-based, and physiological data will be collected at baseline and 26, and 52 weeks after the start of the intervention. The primary outcomes are pain (severity, quality, interference, medication use), mental health (mood, anxiety, catastrophizing), function (self-efficacy, coping, health-related quality of life, sleep, fatigue, communication, physical activity), healthcare utilization, missed work days, and gait speed.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 196 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
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Exclusion Criteria:
Participants randomly assigned to this arm will, following a baseline assessment, immediately begin attending a 6-week Chronic Pain Self-Management Program (CPSMP) workshop.
Behavioral: Chronic Pain Self-Management Program (CPSMP)
Participants assigned to this arm will wait six months after a baseline assessment and then attend the 6-week Chronic Pain Self-Management Program (CPSMP) workshop.
Behavioral: Chronic Pain Self-Management Program (CPSMP)
Stanford University's Chronic Pain Self-Management Program (CPSMP) was developed by Sandra LeFort in 1996 and based on Stanford's Arthritis Self-Management Program and the Chronic Disease Self-Management Program. The 6-week community-delivered workshop consists of 2.5-hour weekly sessions for people with a primary or secondary diagnosis of Chronic Pain.
Pain severity
Using Stanford's 0-10 Pain Visual Numeric Scale participants will rate their pain in the past 2 weeks on an 11-item scale ranging from 0 (no pain) to 10 (severe pain).
Time frame: Change between baseline and 52 weeks
Defense and Veterans Pain Rating Scale
Using the Defense and Veterans Pain Rating Scale will rate their pain in the past 2 weeks on an 11-item scale ranging from 0 (no pain) to 10 (severe pain).
Time frame: Change between baseline and 52 weeks
Pain interference with sleep
Defense and Veterans Pain Rating Scale Supplemental Question (revised from 24 hours to past 2 weeks)
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain frequency
2016 NHIS (past 3 months)
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Perceived disability
Pain Disability Index
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain avoidance
Tampa Scale of Kinesiophobia. A total score is calculated that ranges from 17 (low degree of kinesiophobia) to 68 (a high degree of kinesiophobia)
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Opioid misuse
Screener and Opioid Assessment for Patients with Pain (SOAPP) v1.0-SF
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Medication Usage
Morphine milligram equivalents (MME) per day of current prescription or over-the-counter medications for pain, depression, anxiety, mood, or sleep (also usage of stimulants and muscle relaxers)
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Mood
Stanford Personal Health Questionnaire-Depression (PHQ-8)
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Anxiety
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Catastrophizing
Pain Catastrophizing Scale. The total score ranges from 0 (low catastrophizing) to 52 (high catastrophizing). There are 3 subscales (rumination, magnification, and helplessness)
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Mindfulness
5 Facet Mindfulness Questionnaire Short Form
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Pain Self-Efficacy
Pain Self-Efficacy Scale. The total score ranges from 0 (low self-efficacy) to 60 (high self-efficacy)
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Coping
Coping Strategies Questionnaire-Revised
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Activation
Patient Activation Measure
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
General Health Status
2016 BRFSS question
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Vitality
SF-36 v1
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Minutes of Physical Activity
2016 NHIS questions
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
Healthcare Utilization
Emergency room visits and doctor/clinic visits
Time frame: Monthly for up to 12 months
Work
Number of days missed work and number of days in bed more than half of the day
Time frame: Monthly for up to 12 months
Gait speed
5- or 10-meter gait speed test
Time frame: Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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