Results Summary
What was the research about?
Arthritis is a long-term health problem that causes joint swelling, pain, and reduced motion. Compared with white Americans, African Americans are more likely to have arthritis and to report higher levels of arthritis pain.
In this study, the research team wanted to learn if a pain coping skills training program tailored for African Americans with hip or knee arthritis reduced pain severity. The team worked with African-American patients, doctors, and public health workers to make the program culturally appropriate for African Americans with arthritis. The team also looked at the program’s effect on how patients thought about and lived with pain. The team compared patients who took part in the program and also received their usual care with those who received their usual care only.
What were the results?
After three or nine months, patients who were in the training program didn’t differ in pain severity reduction compared with those who weren’t in the program.
But compared with those who weren’t in the program, patients in the program
- Had higher confidence in their ability to manage arthritis
- Had fewer negative thoughts when in pain
- Used pain coping strategies more often
- Reported more improvement in arthritis symptoms
The groups didn’t differ in
- Ability to do daily activities
- Symptoms of depression
- Overall mental and physical health
Who was in the study?
The study included 248 African Americans with hip or knee arthritis. Patients received care at one of two health systems in North Carolina. The average age was 59, and 51 percent were men.
What did the research team do?
The research team assigned patients by chance to receive the program or not. During the study, all patients continued their usual arthritis care. The program offered 11 weekly training sessions. A counselor led these sessions on the phone for 30–45 minutes. During sessions, the counselor
- Taught pain coping skills, such as relaxation and managing negative thoughts
- Helped patients practice those skills
- Helped patients set goals for using the skills
- Encouraged problem solving
Patients in the program got handouts for each session. They also got an audio guide for muscle relaxation. Patients filled out surveys at the start of the program and three and nine months after the program ended.
Patients, doctors, and public health workers gave feedback throughout the study.
What were the limits of the study?
Patients in the study lived in one region of North Carolina. Results may differ in other locations. Also, 20 percent of patients in the program went to fewer than two sessions. The low attendance may have affected the study’s results.
Future research could continue to explore ways to help African Americans with hip or knee arthritis cope with pain. Researchers could also look at ways to improve attendance at training sessions.
How can people use the results?
African Americans with arthritis and their doctors could use these results when considering ways to manage arthritis pain.
Professional Abstract
Objective
To compare the effectiveness of a pain coping skills training (pain CST) program culturally tailored for African Americans with hip or knee osteoarthritis plus usual care versus usual care alone in reducing pain severity
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 248 African-American adults with hip or knee osteoarthritis |
| Interventions/ Comparators |
|
| Outcomes | Primary: pain severity Secondary: physical function, pain interference, mental and physical health, pain coping attempts, pain catastrophizing, depressive symptoms, arthritis self-efficacy, physical activity, patient impressions of osteoarthritis symptoms |
| Timeframe | 9-month follow-up for primary outcome |
Compared with white Americans, African Americans are more likely to have osteoarthritis and report higher levels of osteoarthritis-related pain. This randomized controlled trial compared the effectiveness of a pain CST program culturally tailored for African Americans with hip or knee osteoarthritis plus usual care versus usual care alone in reducing pain severity. The research team based the program on existing pain CST programs for patients with various chronic pain conditions and then engaged clinicians, public health representatives, and African Americans with osteoarthritis to help make the program culturally appropriate, such as presenting skills in a way that reflected the patients’ cultural and spiritual values.
All patients received their usual care for osteoarthritis throughout the study. The research team randomly assigned patients to receive the pain CST program plus usual osteoarthritis care or usual care alone. The program included 11 weekly, 30–45 minute telephone sessions with a counselor. During sessions, the counselor taught patients cognitive and behavioral pain coping skills, helped patients practice these skills, worked with patients to set goals for applying them, and encouraged problem solving. Patients in the program also received handouts during each session and an audio guide for muscle relaxation. All patients completed follow-up surveys on study outcomes at the start of the program and three and nine months after the program ended.
The study included 248 African Americans with hip or knee osteoarthritis who received care at one of two health systems in North Carolina. The average age was 59, and 51% were male.
Patients, clinicians, and public health and advocacy organization representatives provided feedback throughout the study.
Results
Patients in the pain CST program and those who received usual care alone did not differ in reported reductions in pain severity after three or nine months.
Compared with those who received usual care alone, patients in the pain CST program reported more improvement in arthritis self-efficacy, reduction in pain catastrophizing, increases in pain coping attempts, and improvement in patient impressions of arthritis symptoms (all p<0.01). The groups did not differ in any other secondary outcomes.
Limitations
Patients in the study all lived in one region of North Carolina. Results may differ in other locations. Also, 20% of patients in the pain CST program attended fewer than two sessions, which may have affected the study’s results.
Conclusions and Relevance
Compared with usual care alone, the pain CST program did not improve pain severity among African Americans with hip or knee osteoarthritis. However, the program improved measures of pain coping and perceived ability to manage pain.
Future Research Needs
Future research could continue to explore ways to help African Americans with hip or knee osteoarthritis cope with pain. Researchers could also examine ways to improve intervention adherence.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers expressed concern about the report’s recommendation to disseminate the pain coping skills training intervention when the results for the primary outcome did not show a benefit. The researchers said they included the recommendation because of promising findings from secondary outcomes but agreed that the conclusion should rely more on the primary outcome. As a result, the researchers removed the recommendation for dissemination from both the report’s abstract and conclusion.
- Some reviewers requested that the researchers include a per-protocol analysis based on sessions completed, rather than just the more robust intention-to-treat analysis, but the editor told the researchers that this was not necessary. The researchers added an analysis focusing on participants who attended at least seven sessions, the complier average causal effect, because they had already been asked to provide this analysis for their primary results journal publication.
- The reviewers questioned the inclusion of the 12-Item Short Form Survey, SF-12, as an outcome measure of quality of life, since this can be insensitive to change over a period as short as one year. The researchers acknowledged this limitation but stated that they included the measure not because they expected to see a difference in overall health but in response to stakeholders’ recommendations. They also noted that the SF-12, as a common measure, can be used as a metric to compare this study sample to other studies.
- The reviewers asked the researchers to provide more information about how they handled the higher loss to follow-up in the intervention group than the comparison group. The reviewers also suggested that this difference be noted as a limitation. The researchers explained that they accounted for this differential loss to follow-up by including the treatment arm into their analytic models as well as using multiple imputation for missing data. The result, they stated, was an unbiased treatment effect estimate. The researchers also noted that they separately addressed the issue of lower treatment engagement in the intervention group.