N/A
Completed N=248
Pain Coping Skills Training for African Americans With Osteoarthritis
Source: ClinicalTrials.gov NCT02560922 ↗Enrolled (actual)
248
Serious AEs
8.5%
Results posted
Apr 2019
Primary outcomePrimary: Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale — -1.59; -0.96; -2.24; -1.40 units on a scale — p=0.128
Summary
This study will examine the effectiveness of an 11-session, culturally enhanced, telephone-based pain coping skills training program among African Americans with hip or knee osteoarthritis (OA). The study team will enroll n=248 African Americans with hip or knee OA. The participants will be randomized into two groups. One group will take part in an 11-week pain CST intervention. The other group will be a "wait list" that receives the pain CST program after completing all follow-up study measures. All study participants will be able to continue any other usual medical care for their OA during the study period. The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management. The main study outcome will be the pain subscale of the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). Other outcomes will include the WOMAC function subscale, Coping Strategies Questionnaire, Arthritis Self Efficacy Scale, depressive symptoms, Health-Related Quality of Life, and Patient Global Impression of Change.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale |
-1.59; -0.96; -2.24; -1.40 | 0.128 |
| SECONDARY Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score |
-6.60; -3.98; -8.81; -5.50 | 0.129 |
| SECONDARY Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale |
-4.08; -2.46; -5.60; -3.41 | 0.209 |
| SECONDARY Change From Baseline to Month 3 and Change From Baseline to 9 Month in PROMIS Pain Interference (Short Form 6a) |
-2.63; -1.80; -2.75; -1.61 | 0.222 |
| SECONDARY Change From Baseline to Month 3 and Change From Baseline to 9 Month in Short Form (SF)-12 Physical Component Health Score |
2.60; 0.89; 2.47; 1.74 | 0.111 |
| SECONDARY Change From Baseline to Month 3 and Change From Baseline to 9 Month in SF-12 Mental Component Health Score |
-0.72; -1.48; -0.57; -2.28 | 0.433 |
| SECONDARY Change From Baseline to Month 3 and Change From Baseline to 9 Month in Coping Strategies Questionnaire (CSQ) |
16.46; 1.15; 9.27; -2.40 | 0.001 sig |
| SECONDARY Change From Baseline to Month 3 and Change From Baseline to 9 Month in Patient Health Questionnaire 8 (PHQ-8) |
-0.32; 0.18; -0.89; 0.13 | 0.356 |
| SECONDARY Change From Baseline to Month 3 and Change From Baseline to 9 Month in Arthritis Self-Efficacy Scale |
0.81; -0.20; 0.46; -0.21 | <0.001 sig |
| SECONDARY Patient Global Impression of Arthritis Symptom Change From Baseline (BL) at 3 and 9 Months |
2.91; 4.18; 3.25; 4.13 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- African American (based on self-reported race)
- Diagnosis of hip or knee osteoarthritis; current joint symptoms
Exclusion Criteria
- Diagnosis of gout (in knee or hip), rheumatoid arthritis, fibromyalgia, other systemic rheumatic disease
- Dementia or other memory loss condition
- Active diagnosis of psychosis, serious personality disorder, or current uncontrolled substance abuse
- Total hip / knee replacement surgery, other knee / hip surgery, anterior cruciate ligament tear, or other significant hip / knee injury in the past 6 months
- Severely impaired hearing or speech (patients must be able to participate in video-conference sessions)
- Unable to speak English
- Participating in another OA intervention or CST study
- Unwilling to be randomized either study arm
- Lower extremity paralysis
Data sourced from ClinicalTrials.gov (NCT02560922). 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. Informational only — not medical advice.