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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582683
• Other study ID #: 3U48DP005004-04S1
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: April 9, 2021

Study information

• Verified date: April 2021
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: April 9, 2021
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	West Virginia School of Osteopathic Medicine	Lewisburg	West Virginia
United States	Mid-Ohio Valley Health Department	Parkersburg	West Virginia

Sponsors (4)

Lead Sponsor	Collaborator
West Virginia University	Centers for Disease Control and Prevention, Mid-Ohio Valley Health Department, West Virginia School of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Healthcare Utilization	Emergency room visits and doctor/clinic visits	Monthly for up to 12 months
Secondary	Work	Number of days missed work and number of days in bed more than half of the day	Monthly for up to 12 months
Secondary	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.