Trial of Chronic Pain Self-Management in Clinic or Community for Low-Income Hispanics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating Clinic- and Community-Based Pain Self-Care Programs for Low-Income Hispanics on Opioids

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Community-based pain self-management
* Behavioral: Clinic-based pain self-management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Community-based pain self-management<br>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) | Behavioral: Community-based pain self-management<br> <br> |
| Active Comparator: Clinic-based pain self-management<br>Clinic-based pain self-management: 30-45 minute individualized meetings once monthly for 6 months (total 6 meetings) | Behavioral: Clinic-based pain self-management<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five Times Sit-to-stand (5XSTS) | 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. | Change from Baseline sit-to-stand at 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50-foot Speed Walk (50FtSW) | This test requires participants to walk along a 25-foot walkway turn around and return to the starting point. They are instructed to safely walk as fast as they can and the time taken to complete the test is recorded in seconds. | Change from Baseline 50-foot speed walk at 3 and 6 months | 
| Patient Specific Functional Scale (PSFS) | This is a brief, one-page document that prompts subjects to identify limitations to three activities, rank the importance of these activities, and track progress over time. The activities are scored on a scale of 0 to 10, where 0 indicates that the subject is unable to perform the activity and 10 indicates ability to perform the activity at the same level as before the injury or problem. The total summed score is divided by the number of activities, where a lower score would indicate less ability to perform the task, and the higher score would indicate easier performance of the task. | Change from Baseline PSFS at 3 and 6 months | 
| Symbol-Digit Modalities Test (SDMT) | Participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes (written and oral versions) with the correct digit assigned to a particular symbol. Total correct responses within 90 seconds were measured. The score of the test is the number of correct substitutions completed within the time limit, with a maximum score of 110. A score under 33 is generally considered to be a clear indicator of the existence of some type of cognitive disorder. The higher the score, the better the cognitive function. | Change from Baseline SDMT at 3 and 6 months | 
| The Brief Pain Inventory (BPI): Severity | The BPI is brief and uses simple 0-10 rating scales to measure pain intensity, where zero is no pain and ten is most intense pain imaginable. | Change from Baseline BPI at 3 and 6 months | 
| The Brief Pain Inventory (BPI): Interference | The BPI is brief and uses simple 0-10 rating scales to measure the degree to which pain interferes with common dimensions of feeling and function, where zero is does not interfere and ten is completely interferes. | Change from Baseline BPI at 3 and 6 months | 
| 6-minute Distance Walk (6MW) | For this test, participants walk as far as they can for six minutes, and the total distance in feet is measured with a surveyor's wheel pushed by a research assistant walking behind the subject. Participants can pause or stop as necessary. | Change from Baseline 6-minute distance walk at 6 months | 
| Borg Perceived Effort (Borg) | Completed in conjunction with the 6-minute walk, this measures intensity and perceived effort after the test using a 0-10 Likert-type scale. Anchor words for the effort scales are no effort and most intense effort imaginable. | Change from Baseline perceived effort at 6 months | 
| Medical Outcomes Study 12-Item Short Form Physical Component Summary (SF-12 PCS) | The 12-item Short Form Health Survey created for Medical Outcomes Study measures physical summary scores through a brief survey with limited respondent burden while retaining precision. Physical Health Composite Scores are computed using the scores of 12 questions and range from 0 to 100, where 0 indicates the lowest level of health, and 100 indicates the highest level of health. | Change from Baseline SF-12 PCS at 6 months | 
| Medical Outcomes Study 12-Item Short Form Mental Component Summary (SF-12 MCS) | The 12-item Short Form Health Survey created for Medical Outcomes Study measures mental summary scores through a brief survey with limited respondent burden while retaining precision. Mental Health Composite Scores are computed using the scores of 12 questions and range from 0 to 100, where 0 indicates the lowest level of mental health, and 100 indicates the highest level of mental health. | Change from baseline SF-12 MCS at 6 months | 
| Patient Health Questionnaire -9 (PHQ-9) | The PHQ-9 is a brief, self-administered questionnaire that assesses somatic symptom severity. Participants rate the severity of 15 somatic symptoms as 0 (not bothered at all), 1 (bothered a little) or 2 (bothered a lot). The scores are totaled, with a possible total of 30, which would mean the most severe somatic symptoms, and 0 meaning the least somatic symptoms. | Change from Baseline PHQ-9 at 6 months | 
| Tampa Scale for Kinesiophobia (TSK) | This is a 11-item questionnaire, where individuals score items on a scale of 1 to 4 (1=strongly disagree, 4=strongly agree) to measures fear of completing physical activities. The scores are totaled for all items, to give a possible score of 44, which would indicate a greater fear of injuring oneself. A lower score would indicate less fear of injury to oneself. | Change from Baseline TSK at 6 months |