N/A
N=111
Trial of Chronic Pain Self-Management in Clinic or Community for Low-Income Hispanics
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT02906358 ↗Enrolled (actual)
111
Serious AEs
2.7%
Results posted
Nov 2018
Primary outcome: Primary: Five Times Sit-to-stand (5XSTS) — -4.53; -5.20; -4.18; -6.43 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Community-based pain self-management (Behavioral); Clinic-based pain self-management (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Five Times Sit-to-stand (5XSTS) |
-4.53; -5.20; -4.18; -6.43 | — |
| SECONDARY 50-foot Speed Walk (50FtSW) |
-1.58; -1.22; -1.32; -1.42 | — |
| SECONDARY Patient Specific Functional Scale (PSFS) |
1.07; 1.04; 1.64; 1.65 | — |
| SECONDARY Symbol-Digit Modalities Test (SDMT) |
4.19; 6.84; 4.61; 7.37 | — |
| SECONDARY The Brief Pain Inventory (BPI): Severity |
-0.90; -1.17; -0.95; -1.08 | — |
| SECONDARY The Brief Pain Inventory (BPI): Interference |
-0.31; -1.15; -1.09; -1.37 | — |
| SECONDARY 6-minute Distance Walk (6MW) |
20.0; 193.9 | — |
| SECONDARY Borg Perceived Effort (Borg) |
-0.21; -1.76 | — |
| SECONDARY Medical Outcomes Study 12-Item Short Form Physical Component Summary (SF-12 PCS) |
2.20; 6.76 | — |
| SECONDARY Medical Outcomes Study 12-Item Short Form Mental Component Summary (SF-12 MCS) |
41.44; 39.39 | — |
| SECONDARY Patient Health Questionnaire -9 (PHQ-9) |
-2.08; -3.45 | — |
| SECONDARY Tampa Scale for Kinesiophobia (TSK) |
-2.64; -2.77 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02906358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.