Randomized Trial of Chronic Pain Self-Management Program in the Community or Clinic for Low-Income Primary Care Patients

Abstract

Background: Patients with chronic pain often lack the skills and resources necessary to manage this disease.

Objective: To develop a chronic pain self-management program reflecting community stakeholders' priorities and to compare functional outcomes from training in two settings.

Design: A parallel-group randomized trial.

Participants: Eligible subjects were 35-70 years of age, with chronic non-cancer pain treated with opioids for >2 months at two primary care and one HIV clinic serving low-income Hispanics.

Interventions: In one study arm, the 6-month program was delivered in monthly one-on-one clinic meetings by a community health worker (CHW) trained as a chronic pain health educator, and in the second arm, content experts gave eight group lectures in a nearby library.

Main measures: Five times Sit-to-Stand test (5XSTS) assessed at baseline and 3 and 6 months. Other reported physical and cognitive measures include the 6-Min Walk (6 MW), Borg Perceived Effort Test (Borg Effort), 50-ft Speed Walk (50FtSW), SF-12 Physical Component Summary (SF-12 PCS), Patient-Specific Functional Scale (PSFS), and Symbol-Digit Modalities Test (SDMT). Intention-to-treat (ITT) analyses in mixed-effects models adjust for demographics, body mass index, maximum pain, study arm, and measurement time. Multiple imputation was used for sensitivity analyses.

Key results: Among 111 subjects, 53 were in the clinic arm and 58 in the community arm. In ITT analyses at 6 months, subjects in both arms performed the 5XSTS test faster (-4.9 s, P = 0.001) and improved scores on Borg Effort (-1, P = 0.02), PSFS (1.6, P < 0.001), and SDMT (5.9, P < 0.001). Only the clinic arm increased the 6 MW (172.4 ft, P = 0.02) and SF-12 PCS (6.2 points, P < 0.001). 50ftSW did not change (P = 0.15). Results were similar with multiple imputation. Five falls were possible adverse events.

Conclusions: In low-income subjects with chronic pain, physical and cognitive function improved significantly after self-management training from expert lectures in the community and in-clinic meetings with a trained health educator.

Trial registration: ClinicalTrials.gov NCT02906358.

Keywords: Hispanic; chronic pain; low-income populations; patient engagement; self-management.

Figure 1

Consolidated Standards of Reporting Trials (CONSORT) flow diagram. *Medical exclusions: severe medical or psychiatric comorbidity, cancer pain, mild pain, unable to walk, pregnant, surgery.

Figure 2

Model-based estimated mean five times sit-to-stand test (5XSTS) performance (s) over time with 95% confidence intervals. Linear mixed-effects model adjusted for time, group, sex, ethnicity, baseline age, baseline body mass index, and baseline maximum pain. Vertical lines indicate 95% confidence intervals.

Figure 3

Model-based estimated mean secondary outcomes over time. Linear mixed-effects models adjusted for time, group, sex, ethnicity, baseline age, baseline BMI, and baseline maximum pain for 50-ft speed walk, Borg Perceived Effort, Patient-Specific Functional Scale, and Symbol–Digit Modalities Test. Model adjusted for time, group, time × group, sex, ethnicity, baseline age, baseline body mass index, and baseline maximum pain for 6-min walk. Model adjusted for time, group, time × group, sex, survey language, baseline age, baseline BMI, and baseline maximum pain for 12-Item Short-Form Physical Component Summary (SF-12 PCS). Vertical lines indicate 95% confidence intervals. Figure 3.1 6-Min walk. Figure 3.2 Borg Perceived Effort. Figure 3.3 50-Ft speed walk. Figure 3.4 12-Item Short-Form Physical Component Summary. Figure 3.5 Patient-Specific Functional Scale. Figure 3.6 Symbol–Digit Modalities Test.