What was the research about?
Chronic pain is pain that lasts for months or years. People who live in ethnically diverse communities and neighborhoods with few resources are less likely to receive needed treatment for health issues, such as chronic pain. One way to treat chronic pain is acupuncture therapy. In this therapy, an acupuncturist treats specific points on the body using heat, pressure, or electrical stimulation, or by inserting thin needles. Group sessions, where one acupuncturist treats several patients at a time, could make it easier for patients to get treatment for chronic pain.
In this study, the research team wanted to see if they could show that group acupuncture sessions weren’t worse than one-on-one sessions. Such a result would mean no reason exists, based on decreases in pain, to have one-on-one acupuncture sessions rather than group sessions. The team compared how much a patient’s pain disrupted his or her daily life. They also looked at patients’ pain levels, physical and mental health, and how much better patients said they felt.
What were the results?
Three months after treatment ended, 30 percent of patients who had group acupuncture sessions reported large decreases in how much pain disrupted their daily life, compared with 38 percent of those who had individual sessions. Based on their statistical analyses of these results, the research team could not say that group acupuncture sessions weren’t worse than one-on-one sessions.
Who was in the study?
The study included 706 patients receiving care at six health centers in Bronx, New York. Patients had chronic back or neck pain or pain from osteoarthritis. Of the patients, 35 percent were African American, 13 percent were white, 5 percent were American Indian, and 33 percent marked their race as other; 57 percent were Hispanic. The average patient age was 55, 80 percent were women, and 76 percent had Medicaid. Also, 60 percent said they had poor or fair health and 37 percent couldn’t work due to disability.
What did the research team do?
The research team assigned patients by chance to get acupuncture therapy either in group or one-on-one sessions. In both cases, licensed acupuncturists delivered 12 weekly, 45–60 minute sessions. In group sessions, acupuncturists treated up to six patients in a large room at a community health center. Patients sat in chairs for treatment.
In one-on-one sessions, acupuncturists treated patients in a medical exam room. Patients could choose to lie on a table. Appointments started on the half hour in two rooms, which allowed the acupuncturist to move between patients.
The research team surveyed patients by phone before the start of the study and again three months later.
Patients and health professionals gave input to the research team about recruiting patients and conducting the study.
What were the limits of the study?
The research team, acupuncturists, and patients knew who received individual versus group treatment; this may have affected results. The chairs used in group sessions made it hard to treat patients with back pain because they couldn’t lie down. Without a comparison group that didn’t get acupuncture therapy, the team can’t be certain that the changes were because of the treatment or something else.
Future research could continue to explore ways to make it easier for patients to get acupuncture therapy and other treatments for chronic pain.
How can people use the results?
Health centers can use these results when considering ways to offer acupuncture for patients with chronic pain.
To compare the effectiveness of acupuncture therapy provided in group versus individual sessions in treating chronic pain among ethnically diverse patients with low incomes
|Design||Randomized controlled trial|
|Population||779 patients with chronic back, neck, or osteoarthritic pain|
|Outcomes||Primary: pain interference in daily activities
Secondary: pain severity, physical health, mental health, patient impressions of changes in pain
|Timeframe||3-month follow-up for primary outcome|
This randomized controlled non-inferiority trial compared the effectiveness of acupuncture therapy delivered in group and individual settings in treating chronic pain among ethnically diverse patients with low incomes. People who live in ethnically diverse communities or low-income neighborhoods are less likely to receive needed treatment for chronic pain. Group acupuncture sessions may increase access to treatment for these patients.
Researchers randomized patients with chronic back, neck, or osteoarthritic pain to receive 12 weekly treatments from licensed acupuncturists either in a group or individual setting.
In group sessions, acupuncturists treated up to six patients in a large room at a community health center. Patients sat in chairs for treatment.
For individual sessions, acupuncturists treated patients in a medical exam room. Patients could choose to lie on a table. Appointments started on the half hour. Acupuncturists used two rooms, which allowed them to move between sessions.
The study included 779 patients receiving care from one of six health centers in the Bronx, New York. Of these patients, 35% were African American, 13% were white, 5% were American Indian, and 33% marked their race as other; 57% were Hispanic. The average age was 55, and 80% were female. In addition, 76% had Medicaid; 60% reported poor or fair health, and 37% were unable to work due to disability.
Patients completed a phone survey to assess study outcomes at baseline and again three months later. The trial included a statistical non-inferiority test to determine whether group sessions were not unacceptably worse than individual sessions. The team defined non-inferiority of group to individual sessions to be a maximum difference of 10% in individual therapy response rates compared with group therapy rates.
Patients and health professionals provided input on study design, recruitment, and intervention delivery.
After three months, 30% of patients who had group acupuncture sessions reported a 30% or greater improvement in pain interference in daily activities compared with 38% of those who had individual sessions. In the statistical test for non-inferiority, the confidence interval for the difference in changes in pain interference between group and individual sessions included values that exceeded 10%. As a result, the research team could not declare that group sessions were not inferior to individual sessions.
The two groups did not differ in any secondary outcomes.
Researchers, acupuncturists, and patients were not blinded to group randomization. The chairs for group sessions made it difficult to treat patients with back pain because they could not lie down, as on a table. Because the study did not include a group that was not receiving any acupuncture therapy, the study could not establish with certainty that the changes observed from baseline to after the treatment sessions were a result of those sessions.
Conclusions and Relevance
The study did not demonstrate that group sessions were non-inferior to individual sessions.
Future Research Needs
Future research could continue to explore ways to improve access to acupuncture therapy and other alternative treatments for chronic pain.
Final Research Report
View this project's final research report.
Results of This Project
Related Journal Citations
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 noted that an important limitation of this study was the failure to blind outcome assessors from knowledge of the treatment arm to which participants were assigned. The researchers acknowledged that not blinding data collectors was a limitation and added this point to their discussion of the study’s limitations, but they explained that those who collected outcome data were not necessarily aware of participants’ treatment assignments. They also said that any bias would have been in the direction of favoring group over individual acupuncture. Since group acupuncture was not found to be as effective as individual acupuncture, they believed that the bias, if any, was small.
- The reviewers said the report seemed to imply that both individual and group interventions were both effective, but a conclusion could not be made since the study did not include an arm with no treatment. Therefore, the improvements seen in both individual and group intervention conditions could be the result of changes over time rather than intervention effects. The researchers changed the language throughout the report to focus on differences between the two treatment groups.
- Some of the reviewers suggested that subgroup analysis would be helpful to sort patients by pain level, since pain reduction is not as meaningful for those with minimal pain. The researchers agreed that baseline pain scores can influence the magnitude of change in pain scores. However, dividing participants into subgroups would reduce the sample size for evaluating treatment effects, so instead they used other analytical methods to try to adjust for baseline pain scores.
Conflict of Interest Disclosures
Study Registration Information
- Has Results