What was the research about?
Chronic pain is pain that lasts for months or years. More than 116 million Americans have chronic pain each year. Usual care for chronic pain includes medicine, adjustments to the spine, and physical therapy. Other options that work well include educating patients about chronic pain and teaching skills to manage it. But patients with limited reading skills may find it hard to understand and use these options.
In this study, the research team compared two types of group treatment with usual care alone. The two types of treatment were pain education and cognitive behavioral therapy (CBT). In addition to getting usual care, pain education taught patients about managing chronic pain. CBT taught patients the same information about chronic pain as well as skills for relaxing and managing their pain. The team made the materials for both group treatments easy to use for patients with limited reading skills. This included using large print and drawings and writing at a fifth-grade reading level.
What were the results?
People who got either pain education or CBT along with usual care had less pain than people who had only usual care. They also reported that pain got in the way of doing everyday things less than it did for those who had only usual care. People experienced these improvements slightly more with CBT than with pain education. There were no differences in depression between the groups.
Who was in the study?
The study included 290 patients with chronic pain who got treatment at health clinics in Alabama. Of the people in the study, 71 percent were women, 67 percent were African American, and 33 percent were white. In addition, 68 percent had a high school degree or less and 72 percent had low incomes. People in the study read at between a seventh- and an eighth-grade reading level. The average age was 51.
What did the research team do?
The research team assigned patients to one of three groups by chance. The first group received usual care plus pain education. The second group got usual care plus CBT. Patients in the pain education and CBT groups attended weekly 90-minute group sessions for 10 weeks. The third group received only usual care for chronic pain. The team interviewed all patients before the study, when treatment ended, and again six months after that.
Patients, doctors, and other clinic staff helped the research team design the study and find people to be in the study.
What were the limits of the study?
The study took place in Alabama only. Most of the patients were African-American women with low incomes and a high school degree or less education. The results may be different for other groups of people and people in other locations. Patients had their transportation costs paid for by the study. People may be less likely to come to weekly sessions if the clinic cannot help cover transportation costs.
How can people use the results?
Patients and their doctors may want to use group pain education or group CBT created for patients with limited reading skills to manage patients’ chronic pain. People with limited reading skills can successfully use treatment materials that are easier to read and understand than standard materials.
To examine the effectiveness of treating chronic pain using group pain education and group cognitive behavioral therapy (CBT) that has been adapted for patients with low literacy and provided along with usual care, compared with usual care alone
|Design||Randomized controlled trial|
|Population||290 patients with low literacy levels and a history of chronic pain|
Primary: pain intensity
Secondary: pain interference in daily activities, depression
|Timeframe||6-month follow-up for primary outcome|
In this study, 71% of participants were women, 67% were African American, and 33% were white. In addition, 68% had a high school degree or less education and 72% had incomes at or below the poverty level. On average, participants had a 7.5 grade reading level. The mean age was 51. Patients were receiving treatment at clinics in Alabama.
The research team randomized patients to one of three groups. The pain education group received information about chronic pain with a focus on self-management. The CBT group received CBT, including the same pain education as the other intervention group as well as skills training for relaxation and pain management. Patients in the intervention groups continued to receive usual care. Both interventions were adapted for low literacy, which included providing patient materials that used a large font size and illustrations and were at a fifth-grade reading level. The intervention groups attended weekly 90-minute group sessions for 10 weeks. The usual-care-only group received occasional check-ins by phone from the team.
The research team conducted individual assessments with participants prior to treatment, at the end of treatment at 10 weeks, and 6 months after treatment ended. The team read questions from assessment instruments aloud to participants.
The research team solicited input from patients, medical staff, community health workers, and administrators to help design the study and help recruit and retain participants.
Immediately after treatment, participants in the CBT and pain education groups showed significantly more improvement in pain intensity (CBT and pain education, p=0.05) and pain interference (CBT: p<0.001; pain education: p=0.024) than those in the usual-care-only group. These improvements for both the CBT and pain education groups remained six months after treatment ended, with the exception of pain intensity in the CBT group. Neither the CBT nor the pain education group had a greater reduction in depression scores than the usual-care-only group.
Participants in the CBT group were more than three times as likely as participants in the usual-care-only group to experience at least 30% improvement in pain severity at the end of treatment (p<0.001) and six months after treatment ended (p=0.001). Participants in the pain education group were twice as likely as participants in the usual-care-only group to show at least 30% improvement in pain severity at the end of treatment (p<0.001) and slightly more than twice as likely six months after treatment ended (p<0.001).
Participants in this study were mostly African-American women from a single healthcare system in Alabama. Results may be different for other groups of patients or in other locations. Study coordinators carefully monitored the patients’ care and participation, which may not be feasible in some settings. Participants received compensation for transportation to attend the group sessions. Attendance might fall if the clinic does not cover transportation costs.
Conclusions and Relevance
Compared with usual care alone, adding group CBT or group pain education adapted for patients with low literacy resulted in greater reductions in pain severity and pain interference. Based on a comparison of effect sizes, CBT may perform slightly better than pain education when compared with usual care.
Future Research Needs
Future studies could test whether group pain education and CBT adapted for low literacy work with populations in other healthcare systems or geographical locations. Future research could also explore approaches for facilitating uptake of these treatments in healthcare settings with limited financial resources.
Final Research Report
View this project's final research report.
More to Explore...
Research Gaps in Chronic Pain
Beverly Thorn and Toya Burton talks about some of the challenges of managing symptoms of those suffering from chronic pain.
Results of This Project
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Stories and Videos
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not 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 how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.
In response to peer review, Thorn made changes including
- Adding more details about how the interventions under study were modified for participants with low literacy
- Providing more information about how stakeholders were involved in modifying intervention content
- Clarifying how the study defined clinically meaningful change on a measure of depression symptoms
- Qualifying the results of subgroup analyses by stressing that these results were exploratory and would need future replication
- Describing exploratory sensitivity analyses of the outcomes only for participants who completed an at least six sessions of the interventions, and comparing those results to their main results
Conflict of Interest Disclosures
Study Registration Information
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