Trial of Chronic Pain Self-Management in Clinic or Community for Low-Income Hispanics
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

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.
    

Intervention name(s): Community-based pain self-management; Clinic-based pain self-management
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care