Clinical trial NCT02906358: Trial of Chronic Pain Self-Management in Clinic or Community for Low-Income Hispanics
Official title: Evaluating Clinic- and Community-Based Pain Self-Care Programs for Low-Income Hispanics on Opioids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: The University of Texas at San Antonio
name: Bexar County Hospital District DBA University Health System
name: San Antonio Public Libraries
name: South Central Area Health Education Center
name: The University of Texas System Healthcare Safety & Effectiveness Grants Program
First posted: 2016-09-20
Enrollment: 111
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

The investigators conducted a parallel group, randomized trial of clinic- and community-based programs to educate and promote pain self-management among low-income, predominantly Hispanic patients aged 35-70 who had been prescribed at least two months of OA therapy for chronic non-cancer back and lower extremity pain. Patients were recruited from two primary care clinics and one HIV clinic that treat low-income patients. A total of 111 subjects were randomized to: 1) clinic-based meetings one-on-one with a trained community health worker, or 2) a community-based program in a local library with group lectures by content experts and training in exercises. The same low literacy PowerPoint educational program in Spanish or English was presented to both study arms except in the community, eight lectures about chronic pain self-management were presented plus one lecture about using library resources (biweekly for three months then monthly for three months). Whereas, in the clinic arm, the content was condensed to be covered in six monthly 30-45 minute meetings with the community health worker. To increase availability for subjects in the community arm, the same group session was offered twice a week. Sessions included: 1) Orientation to the pain program; 2) Pain physiology exercises/stretching; 3) Stress management and mindfulness; 4) Massage therapy approaches; 5) Nutrition; 6) Sleep hygiene; 7) Relapse prevention; 8) Health literacy (Internet resources); and 9) Review and long-term pain self-management strategies. To keep the group size manageable, the pain self-management program was held in two cohorts to meet library and clinic space limitations.

All subjects received copies of slides from sessions with photos of local Hispanic community members performing stretching and strengthening exercises at different levels of difficulty. Participants also received activity logs to track personal goals, program DVDs (walking exercises, self-massage techniques), exercise mats, tennis balls for massage and multi-pronged self-massage tools. Physical therapy students helped patients select personalized goals for physical activities. All participants received text messages and phone calls from a coordinator (community) or a community health worker (clinic) to review progress and reinforce meeting attendance. Missed sessions were made up with a coordinator (community arm) or a community health worker (clinic arm).

Baseline and follow-up measures were conducted by physical therapy students, CHWs, or team members not involved in that study arm. Twelve measures of physical, cognitive, and psychological, function and pain were assessed at 6 months in the clinic or the community location and 6 of these were also assessed at 3 months. The primary outcome measure was the five times sit-to-stand test (5XSTS) that was assessed at both 3 and 6 months and reflects both lower extremity strength and balance. The 5XSTS is significantly associated with disability and risk of falls. Secondary outcomes include: 6-minute distance walk test (6MW); Borg Perceived Effort test (Borg effort); 50-foot speed walk test (50FtSW); 12-Item Short Form Survey Physical Component Summary (SF-12 PCS); and Patient Specific Functional Scale (PSFS). Measures of psychological function include: 12-Item Short Form Survey Mental Component Summary (SF-12 MCS), Brief Pain Inventory (BPI), Patient Health Questionnaire-9 (PHQ-9) and the Tampa Scale for Kinesiophobia (TSK). To assess cognitive function, the Symbol-Digit Modalities Test (SDMT) evaluates attention and psychomotor speed. All measures were performed at baseline and the 6-month study endpoint except the following measures also assessed at three months: 5XSTS, 50FtSW, BPI, PSFS and SDMT. These are all validated functional measures (see below). The practical self-management training program evaluated in this trial may offer a valuable resource for primary care practices striving to support their patients with chronic pain, especially those with limited access to other resources.

Impact:

If either or both of the approaches to deliver this chronic pain self-management training program improve patient functional outcomes, they can be easily replicated to evaluate in other low-income populations to improve function and possibly even reduce dependence on OA therapy.

Eligibility criteria: 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

Primary outcomes:
measure: Five Times Sit-to-stand (5XSTS)
timeFrame: Change from Baseline sit-to-stand at 3 and 6 months
Secondary outcomes:
measure: 50-foot Speed Walk (50FtSW)
timeFrame: Change from Baseline 50-foot speed walk at 3 and 6 months
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Change from Baseline PSFS at 3 and 6 months
measure: Symbol-Digit Modalities Test (SDMT)
timeFrame: Change from Baseline SDMT at 3 and 6 months
measure: The Brief Pain Inventory (BPI): Severity
timeFrame: Change from Baseline BPI at 3 and 6 months
measure: The Brief Pain Inventory (BPI): Interference
timeFrame: Change from Baseline BPI at 3 and 6 months
measure: 6-minute Distance Walk (6MW)
timeFrame: Change from Baseline 6-minute distance walk at 6 months
measure: Borg Perceived Effort (Borg)
timeFrame: Change from Baseline perceived effort at 6 months
measure: Medical Outcomes Study 12-Item Short Form Physical Component Summary (SF-12 PCS)
timeFrame: Change from Baseline SF-12 PCS at 6 months
measure: Medical Outcomes Study 12-Item Short Form Mental Component Summary (SF-12 MCS)
timeFrame: Change from baseline SF-12 MCS at 6 months
measure: Patient Health Questionnaire -9 (PHQ-9)
timeFrame: Change from Baseline PHQ-9 at 6 months
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Change from Baseline TSK at 6 months
Other outcomes:
Locations:
Study officials:
affiliation: UT Health Science Center at San Antonio
name: Barbara J Turner, MD
role: PRINCIPAL_INVESTIGATOR
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