A Community-Based Chronic Pain Self-Management Program in West Virginia

A Randomized Controlled Trial of a Community-Based Chronic Pain Self-Management Program in West Virginia

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Chronic Pain Self-Management Program (CPSMP)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Lewisburg, West Virginia, United States, 24901
      • West Virginia School of Osteopathic Medicine
    • Parkersburg, West Virginia, United States, 26101
      • Mid-Ohio Valley Health Department

Participation Criteria

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 over age 18
• Have chronic pain (pain on most days or everyday) for the past 3 months or more
• Able to attend 1 CPSMP workshop a week over 6 weeks
• Able to attend 3-4 testing sessions for data collection (testing sessions are scheduled before the workshops begin and then six months, one year and, for those assigned to the control group, one and a half years after the start of the study)

Exclusion Criteria:

• Chronic pain caused by current cancer diagnosis or an open wound
• Lack reliable transportation
• Having surgery for the painful area in the next year
• Not community-dwelling (i.e., living in a nursing home, assisted living or personal care home, mental hospital, or correctional facility)
• Not willing to be randomized to either start CPSMP workshop now or in six months
• Participation in another self-management program (e.g., Diabetes Self-Management Program) in the past 12 months
• Unable to speak English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPSMP Intervention; 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); 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.
Active Comparator: Wait-list Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Change between baseline and 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain interference with sleep	Defense and Veterans Pain Rating Scale Supplemental Question (revised from 24 hours to past 2 weeks)	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)	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	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)	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	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)	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)	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)	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)	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	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)	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	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	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	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	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	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	Monthly for up to 12 months
Work	Number of days missed work and number of days in bed more than half of the day	Monthly for up to 12 months
Gait speed	5- or 10-meter gait speed test	Data will be collected at baseline, 26 weeks after the start of the study and 52 weeks after the study start.

Collaborators and Investigators

• Sponsor: West Virginia University
• Collaborators: Centers for Disease Control and Prevention; West Virginia School of Osteopathic Medicine; Mid-Ohio Valley Health Department

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): April 9, 2021
• Study Completion (Actual): April 9, 2021

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Behavioral Health; Self-Management Programs
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 3U48DP005004-04S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No