Evaluating Clinic- and Community-Based Pain Self-Care Programs for Low-Income Hispanics on Opioids
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 111
- Primary Endpoint
- Five Times Sit-to-stand (5XSTS)
Study Overview
Brief Summary
The purpose of this study is to conduct a parallel group, randomized trial of a chronic pain self-management program in clinic or community settings to educate and support low-income, Hispanic patients with chronic pain to adopt evidence-based pain self-care behaviors and activities.
Detailed Description
Background and Significance
Over the past two decades, opioid analgesic (OA) drugs have been increasingly prescribed for chronic pain despite little to no effectiveness of treatment >6 months. In prospective cohorts, OA therapy can worsen pain and disability by promoting a sedentary lifestyle. With rapidly rising deaths from OA overdose and the lack of evidence of long-term effectiveness, the U.S. Department of Health and Human Services (HHS) has developed its National Pain Strategy that sharply limits use of OAs and recommends non-pharmacologic interventions as first line approaches to manage chronic pain. A key aspect of a non-pharmacologic approach to managing chronic pain is educating patients about self-management in order to help them lead more productive lives and perform daily activities despite their pain. Self-management training is especially important for low-income patients who need practical, low cost ways to learn how to live fuller, more productive lives despite having chronic pain. To respond to this need to support low-income patients with chronic pain, we developed a chronic pain self-management program based on unmet needs identified by stakeholders from rural, largely Hispanic communities. We conducted a randomized trial to examine outcomes of two settings to deliver this self-management training program. Both settings evaluated whether patients' function improved when the same program was delivered in clinic in individual meetings with a trained community health worker or in a local community-based setting from group lectures by content experts. The training program in both settings offered education and training about such topics as: pain physiology and goal setting; stretching; strengthening; massage, and mindfulness techniques. This program not only reflects the unmet needs of rural, predominantly Hispanic stakeholders with chronic pain but also elements of other self-management programs for patients with chronic back and lower extremity musculoskeletal pain. However, this program was specifically designed for a low literacy, bilingual patient population with limited access to resources to help with non-pharmacologic management of chronic pain.
Objective:
To develop a chronic pain self-management program reflecting community stakeholders' priorities and conduct a randomized trial to evaluate functional outcomes from training in two settings. Subjects will be randomized to receive a 6-month pain self-management training program in: 1) Six 30-to-45 minute individual meetings with a trained community health worker in clinic or 2) nine 1-hour meetings for group lectures by content experts and practicing physical activities held in nearby public libraries.
Study Design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Active patient in two study primary care clinics or HIV clinic in same system
- •Prescribed OAs >2 mos in the past year
- •Back/lower extremity pain
- •English or Spanish speaking
Exclusion Criteria
- •Unstable comorbidity
- •Cardiovascular/pulmonary disease that prevents exercise
- •Cancer-related pain
- •Significant mental health disorder
- •Alcohol or drug abuse
- •Inability to walk unassisted for at least one block
- •Inability to provide consent (e.g., dementia)
- •Residing more than 10 miles from clinic (poor transportation)
- •Patients who are unable or unwilling to attend clinic- or community-based sessions
Arms & Interventions
Community-based pain self-management
Community-based pain self-management: two, one-hour meetings monthly for the first three months (6 meetings) and one meeting per month for the last three months (total 9 meetings)
Intervention: Community-based pain self-management (Behavioral)
Clinic-based pain self-management
Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings)
Intervention: Clinic-based pain self-management (Behavioral)
Outcomes
Primary Outcomes
Five Times Sit-to-stand (5XSTS)
Time Frame: Change from Baseline sit-to-stand at 3 and 6 months
Participants are instructed to sit and stand up five times as fast as they can from a standard armless chair while the researcher times how many seconds it takes them to complete the task. After a brief rest, they repeat the test a second time and the average of two tests is calculated.
Secondary Outcomes
- 50-foot Speed Walk (50FtSW)(Change from Baseline 50-foot speed walk at 3 and 6 months)
- The Brief Pain Inventory (BPI): Severity(Change from Baseline BPI at 3 and 6 months)
- Borg Perceived Effort (Borg)(Change from Baseline perceived effort at 6 months)
- 6-minute Distance Walk (6MW)(Change from Baseline 6-minute distance walk at 6 months)
- Medical Outcomes Study 12-Item Short Form Physical Component Summary (SF-12 PCS)(Change from Baseline SF-12 PCS at 6 months)
- Medical Outcomes Study 12-Item Short Form Mental Component Summary (SF-12 MCS)(Change from baseline SF-12 MCS at 6 months)
- Patient Health Questionnaire -9 (PHQ-9)(Change from Baseline PHQ-9 at 6 months)
- Patient Specific Functional Scale (PSFS)(Change from Baseline PSFS at 3 and 6 months)
- Symbol-Digit Modalities Test (SDMT)(Change from Baseline SDMT at 3 and 6 months)
- Tampa Scale for Kinesiophobia (TSK)(Change from Baseline TSK at 6 months)
- The Brief Pain Inventory (BPI): Interference(Change from Baseline BPI at 3 and 6 months)
