Chronic Pain
Conditions
Keywords
health equity, integrative health, nonpharmacologic pain management, stigma, social isolation, primary care, group medical visits
Brief summary
Socioeconomically disadvantaged populations have a high prevalence of chronic pain, exacerbated by social isolation, intersectional stigma, and disparities in pain assessment and treatment options. Effective interventions using a multilevel, biopsychosocial approach are needed to decrease the unequal burden of pain. The proposed pilot study will test group-based integrative models of pain management in primary care safety net clinics to improve pain care for racially and ethnically diverse low-income patients.
Detailed description
Background: The proposed pilot study seeks to address chronic pain disparities in racially diverse, socioeconomically disadvantaged individuals by optimizing multimodal pain management provided in primary care safety net clinics. Multilevel barriers exist in primary care settings where socioeconomically disadvantaged patients are most often treated. Lack of access to multimodal and nonpharmacologic care at the organizational level alongside provider bias and other forms of discrimination at the interpersonal level contribute to unequal assessment, treatment, and quality of pain care. Stigmatization cross-cuts all levels and is closely linked with social isolation common among individuals with chronic pain. Group-based models are a promising multilevel approach to increase access to non-pharmacologic therapies, address time constraints that contribute to disparities in pain care, improve patient-clinician communication, and provide social support among safety net patients with chronic pain. Methods: This pilot study uses mixed methods and a pragmatic 2x2 randomized factorial trial to test two group-based models: integrative group medical visits (IGMV) and group acupuncture. Study interventions include 12 weekly sessions based on existing protocols tested in primary care safety net settings. IGMV includes pain education, social and behavioral support, and mind-body approaches (meditation, yoga). Group acupuncture uses responsive manualization, allowing for a standardized yet individualized treatment. During this pilot study, a panel of national experts and patient stakeholders will refine and optimize the structure, process, and content of IGMV aimed at reducing social isolation and intersectional stigma as part of pain management. Interventions will be piloted in 40 English or Spanish speaking patients with chronic pain at two primary care safety net clinics. Study procedures will be tested and adapted for a larger scale trial. The larger study will test the hypotheses that compared with usual care, each study intervention improves pain interference and social isolation (primary outcomes), and that the two combined have synergistic effects mediated by increased social support and decreased impact of intersectional stigma among safety net patients with chronic pain. Significance: Multilevel approaches are needed to advance health equity in pain management. The proposed study will contribute to knowledge of group-based integrative pain management co-located in primary care to address disparities in pain care for socioeconomically vulnerable populations. The study receives support from the Helping to End Addiction Long-term® (HEAL) Initiative (https://heal.nih.gov/).
Interventions
OTHERgroup acupuncture
Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles.
IGMV sessions will be weekly for 90 minutes in a group meeting space. Sessions will start with a check-in where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
2x2 factorial trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults aged \> 18 * fluency in English or Spanish; * panelled to a primary care provider at one of the study clinics; * diagnosis of chronic pain (\> 3 months); * had a primary care visit for chronic pain within the past six months; * ability to provide a phone number; * able to participate in groups; * intent to be available for up to 24 weeks.
Exclusion criteria
* current anticoagulant use * active cancer treatment * inability to provide informed consent due to mental illness or cognitive impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eligible Patients Who Are Randomized | Randomization | Percentage of patients with confirmed eligibility who are randomized |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Randomized Participants Who Complete the Study | 3-month follow up | Retention as percentage of randomized who complete 3-month follow up survey |
| Intervention Adherence | 12 weeks | average number of intervention sessions attended |
Other
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Intensity on the 0-10 Numeric Rating Scale | 3-month follow up | Pain intensity in the past 7 days will be measured on the numeric rating scale (NRS), the score ranges from 0-10, with zero indicating no pain and 10 indicating the worst pain imaginable. |
| Pain Interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | 3-month follow up | Self-reported pain interference will be measured using the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of pain interference. |
| Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC) | 3-month follow up | Patient belief about treatment efficacy will be measured using a single item patient global impression of change (PGIC). Total score rates from 1 (very much worse) to 7 (very much improved) |
| Social Isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | 3-month follow up | Self-reported social isolation will be measured using the 8-item PROMIS scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of social isolation. |
| Social Support in Chronic Pain Scale | 3-month follow up | Social Support in Chronic Pain will be measured using Van Der Lugts' 6-item Social Support in Chronic Pain Scale. Total scores range from 0 to 24, with higher scores indicating greater levels of social support. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants will receive care as usual provided through their primary care providers. Usual care includes medical diagnostic evaluation, analgesic drug therapies, recommendations for physical activity, and sometimes referral to specialist physicians or physical therapy. Usual care was chosen as a comparison arm for this study because it is practical and clinically relevant. Participants randomized to usual care will be put on a waitlist and can access group acupuncture or IGMV after their final study visit. | 12 |
| Group Acupuncture Participants randomized to acupuncture will receive 12 weeks of acupuncture treatments delivered in a group setting, dosing similar to prior research. Acupuncture point selection and other treatment details will follow responsive manualization, a protocol developed for the largest clinical trial of group acupuncture to date. A licensed acupuncturist experienced with administering group acupuncture treatments will determine each participant's traditional Chinese medicine diagnosis and administer 8-10 acupuncture needles on distal points of participant's body (below the knees, from the elbows to the hands, and on the head). Duration of assessment, needle placement and retention will be 30-45 minutes. Details of acupuncture treatments (e.g., frequency and duration, traditional Chinese medicine diagnosis, number of needles and points used) will be documented in electronic health records.
Group acupuncture: Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles. | 11 |
| Integrative Group Medical Visits (IGMV) IGMV will consist of a 12-week program that provides education on the biopsychosocial model of pain and multimodal treatments; physical movement; mindfulness training; and peer support. Non-pharmacologic approaches are based on guidelines on chronic pain management; feedback of experts, staff, and patients; and feasibility with the greatest potential to benefit participants. Participants will receive a binder with educational materials.
Integrative Group Medical Visits:
IGMV sessions will be weekly for 90 minutes in a group meeting space. Sessions will start with a check-in where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice. | 11 |
| Group Acupuncture and IGMV Both group acupuncture and IGMV. Along with usual care, participants will be offered weekly group acupuncture treatments and integrative group medical visits as described above.
Group acupuncture: Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. Acupuncture treatments will include a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Acupuncture points will be selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles.
Integrative Group Medical Visits:
IGMV sessions will be weekly for 90 minutes in a group meeting space. Sessions will start with a check-in where participants can share their emotions, thoughts, hopes, and fears related to their health and pain and provide updates since the last session. Group sessions will be led by a primary care provider and a health educator and will include psychosocial support, tools for pain self-management, and psychoeducation for pain management. Invited experts will provide information on educational topics, including neurobiology of pain, medication safety, and connections between mood and pain, as well as participatory activities such as therapeutic movement or mindfulness practice. | 10 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Usual Care | Group Acupuncture | Integrative Group Medical Visits (IGMV) | Group Acupuncture and IGMV | Total |
|---|---|---|---|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 14.6 | 56.5 years STANDARD_DEVIATION 13.3 | 52.1 years STANDARD_DEVIATION 18.3 | 54.4 years STANDARD_DEVIATION 9.5 | 55.2 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 7 Participants | 6 Participants | 4 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 4 Participants | 4 Participants | 5 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Pain Interference (8-item NIH Patient Reported Outcomes Measurement Information System) | 68.0 units on a scale STANDARD_DEVIATION 4.9 | 64.7 units on a scale STANDARD_DEVIATION 5.2 | 68.3 units on a scale STANDARD_DEVIATION 4.1 | 69.1 units on a scale STANDARD_DEVIATION 6.4 | 67.5 units on a scale STANDARD_DEVIATION 5.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 4 Participants | 3 Participants | 18 Participants |
| Race (NIH/OMB) White | 4 Participants | 1 Participants | 3 Participants | 4 Participants | 12 Participants |
| Region of Enrollment United States | 12 participants | 11 participants | 11 participants | 10 participants | 44 participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 7 Participants | 7 Participants | 30 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 4 Participants | 3 Participants | 14 Participants |
| Sex/Gender, Customized Different identity | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Female | 7 Participants | 8 Participants | 6 Participants | 5 Participants | 26 Participants |
| Sex/Gender, Customized Genderqueer/Gender non-conforming | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 4 Participants |
| Sex/Gender, Customized Male | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 10 Participants |
| Sex/Gender, Customized Transfemale/trans woman | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Sex/Gender, Customized Transmale/trans man | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 12 | 0 / 11 | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 | 0 / 11 | 0 / 10 |
Outcome results
Primary
Percentage of Eligible Patients Who Are Randomized
Percentage of patients with confirmed eligibility who are randomized
Time frame: Randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Confirmed Eligible | Percentage of Eligible Patients Who Are Randomized | 44 Participants |
Secondary
Intervention Adherence
average number of intervention sessions attended
Time frame: 12 weeks
Population: for usual care, this measure is not applicable
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Acupuncture | Intervention Adherence | 8.5 intervention sessions | Standard Deviation 2.8 |
| Integrative Group Medical Visits (IGMV) | Intervention Adherence | 5.5 intervention sessions | Standard Deviation 4.8 |
| Group Acupuncture and IGMV | Intervention Adherence | 10.6 intervention sessions | Standard Deviation 7.1 |
Secondary
Percentage of Randomized Participants Who Complete the Study
Retention as percentage of randomized who complete 3-month follow up survey
Time frame: 3-month follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Confirmed Eligible | Percentage of Randomized Participants Who Complete the Study | 40 Participants |
Other Pre-specified
Average Pain Intensity on the 0-10 Numeric Rating Scale
Pain intensity in the past 7 days will be measured on the numeric rating scale (NRS), the score ranges from 0-10, with zero indicating no pain and 10 indicating the worst pain imaginable.
Time frame: 3-month follow up
Population: all participants who completed three-month follow up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Confirmed Eligible | Average Pain Intensity on the 0-10 Numeric Rating Scale | 6.3 score on a scale | Standard Deviation 2.1 |
| Group Acupuncture | Average Pain Intensity on the 0-10 Numeric Rating Scale | 7.3 score on a scale | Standard Deviation 2 |
| Integrative Group Medical Visits (IGMV) | Average Pain Intensity on the 0-10 Numeric Rating Scale | 6.7 score on a scale | Standard Deviation 1.9 |
| Group Acupuncture and IGMV | Average Pain Intensity on the 0-10 Numeric Rating Scale | 6.9 score on a scale | Standard Deviation 2.3 |
Other Pre-specified
Pain Interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey
Self-reported pain interference will be measured using the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of pain interference.
Time frame: 3-month follow up
Population: all participants who completed three-month follow up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Confirmed Eligible | Pain Interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | 62.4 score on a scale | Standard Deviation 6.6 |
| Group Acupuncture | Pain Interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | 66.4 score on a scale | Standard Deviation 7.2 |
| Integrative Group Medical Visits (IGMV) | Pain Interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | 65.5 score on a scale | Standard Deviation 7 |
| Group Acupuncture and IGMV | Pain Interference on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | 63.4 score on a scale | Standard Deviation 7.3 |
Other Pre-specified
Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC)
Patient belief about treatment efficacy will be measured using a single item patient global impression of change (PGIC). Total score rates from 1 (very much worse) to 7 (very much improved)
Time frame: 3-month follow up
Population: Participants who completed 3-month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Confirmed Eligible | Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC) | 2.7 units on a scale | Standard Deviation 1.3 |
| Group Acupuncture | Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC) | 4.5 units on a scale | Standard Deviation 0.7 |
| Integrative Group Medical Visits (IGMV) | Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC) | 4.0 units on a scale | Standard Deviation 1.1 |
| Group Acupuncture and IGMV | Patient Belief About Treatment Efficacy on the Patient Global Impression of Change (PGIC) | 4.3 units on a scale | Standard Deviation 0.7 |
Other Pre-specified
Social Isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey
Self-reported social isolation will be measured using the 8-item PROMIS scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of social isolation.
Time frame: 3-month follow up
Population: all participants who completed three-month follow up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Confirmed Eligible | Social Isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | 52.6 score on a scale | Standard Deviation 10.7 |
| Group Acupuncture | Social Isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | 55.0 score on a scale | Standard Deviation 7.5 |
| Integrative Group Medical Visits (IGMV) | Social Isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | 54.3 score on a scale | Standard Deviation 9.3 |
| Group Acupuncture and IGMV | Social Isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Survey | 53.3 score on a scale | Standard Deviation 9.2 |
Other Pre-specified
Social Support in Chronic Pain Scale
Social Support in Chronic Pain will be measured using Van Der Lugts' 6-item Social Support in Chronic Pain Scale. Total scores range from 0 to 24, with higher scores indicating greater levels of social support.
Time frame: 3-month follow up
Population: all participants who completed three-month follow up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Confirmed Eligible | Social Support in Chronic Pain Scale | 12.2 score on a scale | Standard Deviation 6.2 |
| Group Acupuncture | Social Support in Chronic Pain Scale | 14.5 score on a scale | Standard Deviation 5.4 |
| Integrative Group Medical Visits (IGMV) | Social Support in Chronic Pain Scale | 15.2 score on a scale | Standard Deviation 4.9 |
| Group Acupuncture and IGMV | Social Support in Chronic Pain Scale | 11.6 score on a scale | Standard Deviation 6.3 |