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Abstract

Purpose:

This pilot study tested the feasibility and acceptability of a pragmatic randomized trial evaluating group-based non-pharmacologic approaches to increase access in primary care and improve pain-related outcomes.

Methods:

This 2 × 2 factorial trial assessed two 12-week interventions: group acupuncture and integrative group medical visits (IGMVs). Adults with chronic pain lasting ≥3 months were enrolled from safety-net primary care clinics. Participants were randomized to group acupuncture, IGMVs, both, or neither (usual care). We analyzed data using linear mixed models, ANCOVA, and abductive qualitative analysis.

Results:

Overall, 44 participants were randomized (25 English-speaking and 19 Spanish-speaking); 59% were female (mean age = 55 years), 21% African American or Black, 52% Latine, 21% non-Latine White, and 5% more than 1 race; and 78% had annual income <$25 000. At baseline, the average duration of chronic pain was 13.0 years, and the mean pain impact score was 36.0 (SD = 6.4). Participants randomized to interventions attended 6 of 12 sessions on average; 89% would participate again; and 86% reported clinically relevant pain improvements versus 20% in usual care (P < .001). Qualitative data revealed substantial barriers to accessing multimodal care and social benefits of group-based models.

Conclusion:

Group-based integrative pain management is feasible and acceptable when co-located within safety-net primary care.

Clinicaltrials.gov Registration Number: NCT05906784 (http://clinicaltrials.gov/study/NCT05906784).

Keywords

chronic pain integrative health group medical visits acupuncture primary care

Introduction

Clinical guidelines recommend a multimodal approach to chronic pain treatment, including non-pharmacologic therapies.^1,2 Numerous challenges impede guideline-concordant care in primary care safety-net clinics serving low-income patients with chronic pain, including the length of primary care visits³ and the lack of insurance coverage for many non-pharmacologic therapies.⁴

Established group-based approaches to chronic pain management include group acupuncture and integrative group medical visits (IGMVs), both of which provide simultaneous treatment to multiple patients in a shared space. Group acupuncture lowers costs and improves treatment access,^5,6 without compromising patient perceptions of quality of care.⁷ In previous research with patients from primary care safety-net clinics, group acupuncture was associated with improvements in pain severity, pain interference, and depression in a quasi-experimental study,⁸ and with reduced chronic pain and improved physical function in a randomized clinical trial.⁹ IGMVs combine clinical care, including non-pharmacologic therapies, with health education and peer support.¹⁰ IGMVs provide extended visit time and increase access to multimodal care.^11,12 IGMVs for chronic pain confer multiple benefits, including decreased pain interference, increased self-efficacy,¹¹ improved quality of life,^13-15 lower healthcare utilization,^12,16 and reduced opioid use.^12,17

Social determinants of health, including stigma, racism, and social isolation, profoundly impact pain outcomes^18-23 but are inadequately addressed in clinical care. Social isolation and pain-related stigma have led to dire consequences, including unmanaged pain and overuse of opioids.^17-18 The potential benefits of addressing social factors in pain are understudied. Group-based pain management may fill a significant gap in current pain care by incorporating the “social” aspects of a biopsychosocial approach. Studies of IGMVs have found interpersonal-level benefits, such as decreased social isolation, increased social support, and improved patient-clinician relationships.^24-27 The presence of peers may reduce discriminatory or stigmatizing practices by clinicians.²⁸ The San Francisco Department of Public Health implemented a 12-week Integrative Pain Management Program offering multimodal pain management using a biopsychosocial approach. This program includes IGMVs with pain education, social support, and mind-body approaches (meditation and yoga), group acupuncture, and other non-pharmacologic treatments. In a quasi-experimental study, the program was associated with decreased pain interference, increased pain self-efficacy, and social support.¹¹ Qualitative findings highlighted pain relief through social connection with group members and feeling understood by others who experienced stigma.²⁶

This mixed-methods pilot study aimed to assess the feasibility and acceptability of a pragmatic randomized trial of the program’s group-based components in Spanish and English, in preparation for a larger trial to assess whether acupuncture, IGMVs, or both account for observed benefits in participants.

Methods

Study Design

This pilot pragmatic randomized trial used a 2 × 2 factorial design. The 2 treatment factors were 12 weekly sessions of group acupuncture, and 12 weekly sessions of an IGMV, with half assigned to each factor and half assigned to the absence of the factor. Participants were randomized into 4 equal study arms: (1) group acupuncture, (2) IGMV, (3) concurrent participation in both acupuncture and IGMV, and (4) assignment to neither condition (ie, usual care, with the option to receive acupuncture after study participation), as described in detail elsewhere.²⁹ This study was approved by the University of California San Francisco (UCSF) Institutional Review Board (#22-37078).

Study Procedures

We recruited patients in safety-net primary care clinics that are part of the San Francisco Health Network (SFHN). The inclusion criteria included age ≥18 years, fluency in English or Spanish, empanelment to an SFHN primary care provider, a diagnosis of chronic pain lasting ≥3 months, ability to provide a phone number, ability to participate in groups, and expected availability for 24 weeks. The exclusion criteria were active cancer treatment or inability to provide informed consent.

We assembled a team with substantial experience recruiting and retaining racially and linguistically diverse patients in safety-net clinics. We presented the study to primary care teams and individually contacted clinicians to solicit patient referrals. Bilingual research assistants (Spanish/English) conducted recruitment via phone calls, invited participants to study orientations, and obtained informed consent. Written materials were available in English and Spanish. Following the consent process, a 45- to 60-min baseline assessment was administered. Participants were randomized to 1 of the 4 conditions using a computer-generated list with randomly permuted blocks of 4 and 8, stratified by language.

Study retention efforts included weekly follow-up from a known study team member via phone call and/or text message based on participants’ preferences. Intervention sessions aimed to create a welcoming environment, with consistent staff and flexibility for participant needs (eg, late arrivals and modifications to physical movement). Given the high symptom burden and low incomes of most participants, providing food at study visits was an important part of retention. Participants received gift card incentives.

Measures

We assessed the feasibility of study procedures, including enrollment and randomization, intervention attendance, and survey completion at baseline and 3-month follow-up. We examined the acceptability and impact of interventions on patient experiences with pain management, patient-clinician relationships, and clinical care using participant satisfaction surveys, open-ended questions, interviews, focus groups, and participant-observation of interventions.²⁹

Quantitative

We included measures recommended by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials³⁰ and the National Institutes of Health (NIH) Helping to End Addiction Long-term^® (HEAL) Initiative Common Data Elements. We measured pain impact, which is based on 9 items in the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) and yields scores ranging from 8 to 50.³¹ We measured pain intensity using the PROMIS Pain Intensity instrument, which is a single-item measure with scores ranging from 0 to 10. We measured pain interference using the PROMIS v1.1 Pain Interference 8a instrument (converted to T-scores with a mean of 50 and a standard deviation [SD] of 10 points in reference populations) and the Patient Global Impression of Change questionnaire (a 7-point Likert scale). We measured depression using the Patient Health Questionnaire-2 (PHQ-2) and anxiety using the General Anxiety Disorder-2 (GAD-2), both with scores ranging from 0 to 6.³² We included the PROMIS v1.2 Global Health and PROMIS v2.0 Physical Function 6b measures (converted to T-scores).^33,34 We evaluated social support in chronic pain using a 6-item scale, with scores ranging from 0 to 24³⁵; social isolation using the PROMIS Social Isolation 8a T-score³⁶; internalized stigma in chronic pain using a 28-item scale, with mean scores ranging from 1 to 4³⁷; pain self-efficacy using a 10-item scale, with scores ranging from 0 to 60³⁸; and perceived discrimination using the Intersectional Discrimination Index, a 7-item scale, with scores ranging from 0 to 28.³⁹

Qualitative

All participants were invited to participate in a semi-structured interview at 3-month follow-up. Interview guides were developed to explore participant experiences in each study arm, the impact of study participation on chronic pain management, and broader topics related to life with chronic pain, including social support and isolation, stigma, discrimination, and ideal healthcare. IGMV participants were also invited to participate in a focus group. Trained researchers observed IGMV and acupuncture sessions at weeks 1, 6, and 12, and took structured notes on what occurred during the sessions, including interactions among participants and clinicians and discussions related to social isolation, stigma, and support or belonging.

Data Analysis

Quantitative

Sociodemographic data and baseline patient-reported outcomes were summarized. Feasibility and acceptability metrics were analyzed by computing rates of retention and enrollment as percentages.

As a feasibility pilot, we analyzed clinical outcomes to make a preliminary assessment of the strength of intervention effects, identify potential issues with missing data or skewed distributions, and refine the statistical analysis plan. Analyses included changes from baseline to week 12 within treatment groups and between groups with and without each treatment factor, examining acupuncture versus no acupuncture and IGMV versus no IGMV.

Within-group effects were estimated using linear mixed models, with indicators for assignment to acupuncture and IGMV, timepoint (baseline or follow-up), and interactions between each treatment indicator and time. Models included language as a covariate, and a random intercept for correlation of repeated measures. Between-group treatment effects were estimated using analysis of covariance (ANCOVA), which included baseline scores as a covariate to account for possible group imbalances at baseline. Models had indicators for assignment to acupuncture and IGMV and included a covariate for language.

Qualitative

Interviews and focus groups were audio-recorded and professionally transcribed. We used established qualitative methods, including an abductive approach to flexible coding of data to generate index codes that were both deductive and inductive.^40,41 All qualitative data were coded by 2 trained researchers using Dedoose software, with ongoing team discussions to clarify any coding disagreements. Further analysis for this manuscript focused on identifying connections between quantitative and qualitative findings. We linked sociodemographic data and baseline patient-reported outcomes with qualitative data to facilitate mixed-methods integration.

Results

Study Participants

We received 160 referrals for the study; 116 individuals were excluded because they were uninterested in participating, could not be contacted, or were ineligible (Figure 1). We consented and randomized 44 participants (25 English-speaking and 19 Spanish-speaking). Of these, 20% identified as Black or African American, 52% as Latine, 20% as non-Latine White, and 5% as more than 1 race. The mean age of participants was 55.2 years (SD = 14.0). Most had not completed a 4-year college degree (86%), were not employed (73%), and had an annual household income of <$25 000 (78%; Table 1). Study participants had substantial health challenges: they had experienced chronic pain for an average of 13.0 years (SD = 9.7). The mean pain impact score at baseline was 36.0 (SD = 6.4). Additionally, the majority of participants (66%) had 3 or more chronic conditions.

Figure 1.

CONSORT diagram.

Table 1.

Characteristics of Randomized Study Participants (n = 44).

Participant Characteristics	Mean ± SD or n (%)
Demographics
Age, years	55.2 ± 14.0
Gender identification
Male	10 (23)
Female	26 (59)
Transgender, genderqueer	8 (18)
Race and ethnicity
Black or African American	9 (20)
Hispanic or Latino	23 (52)
White	9 (20)
Other or more than 1 race	2 (5)
Unknown	1 (2)
Education level
Some high school or less	19 (43)
High school graduate	17 (39)
Some college or more	8 (18)
Employment status
Employed (full- and part-time)	12 (27)
Not employed	32 (73)
Marital response status
Divorced or separated	12 (27)
Married	7 (16)
Never married	20 (45)
Widowed	5 (11)
Annual household income
Less than $25 000	32 (78)
$25 000-$49 999	3 (7)
$75 000-$99 999	1 (2)
Prefer not to answer	8 (18)
Has applied for disability insurance for pain^a
No	27 (63)
Yes	16 (37)
Born outside United States	22 (50)
Clinical characteristics
Pain duration^b, years	13.0 ± 9.7
Chronic conditions
Back pain	32 (73)
Depression	28 (64)
High blood pressure	17 (39)
Diabetes	13 (30)
Osteoarthritis, degenerative arthritis	12 (27)
Heart disease	9 (20)
Rheumatoid arthritis	8 (18)
Fibromyalgia	5 (11)
Lung disease	5 (11)
Anemia or other blood disease	4 (9)
Cancer	4 (9)
Ulcer or stomach disease	3 (7)
Liver disease	3 (7)
Other medical problem^c	21 (48)
Average number of chronic conditions	3.8 ± 2.2
Reported ≥3 chronic conditions	29 (66)
Tobacco, Alcohol, Prescription medications, and other Substance use (TAPS) tool (possible substance use)	29 (66)
Past use of non-pharmacologic approaches for pain
Acupuncture	16 (36)
Chiropractic or spinal manipulation	6 (14)
Massage therapy	15 (34)
Movement therapies (eg, yoga, tai chi)	7 (16)
Exercise supervised by a healthcare provider	14 (32)
Class led by a healthcare provider (eg, mindfulness)	7 (16)
Exercise on own	15 (34)
Mind-body techniques on own	13 (30)
Psychological counseling (eg, cognitive behavioral therapy)	12 (27)

The disability insurance pain indicator was missing for n = 1 participant.

Pain duration at baseline was missing for n = 4 participants.

Other medical problems listed by participants included: anxiety, brain tumor, neuropathy, pinched nerves, epilepsy, spinal stenosis, osteoporosis, osteopenia, HIV, endometriosis/pelvic pain and multiple other pain conditions.

Feasibility of Study Procedures

Overall, 12 participants were randomized to usual care, 11 to acupuncture, 11 to IGMV, and 10 to both acupuncture and IGMV. Among participants randomized to an intervention, 94% attended at least 1 session. Participants randomized to acupuncture attended an average of 6.4 sessions, and participants randomized to IGMV attended an average of 6.0 sessions. Follow-up surveys and interviews at 3 months were completed by 39 of 44 participants (89%).

Staff were available at all visits to support patients with limited literacy to read consent forms and complete surveys. Over 75% of Spanish-speaking participants and 50% of English-speaking participants requested staff assistance with survey completion for reasons related to pain and other symptoms, limited literacy, or a lack of familiarity with technology.

Study Acceptability

Participant satisfaction was assessed post-intervention (Table 2). At least 89% of intervention participants said they would participate in the program again and recommend it to others. Among IGMV participants queried about specific aspects of the program, 89% or more reported satisfaction with each aspect.

Table 2.

Participant Satisfaction and Experience.

Participant experience	Acupuncture (n = 19)	IGMV (n = 19)
	Agree or strongly agree	Agree or strongly agree
	n (%)	n (%)
The [intervention] helped me learn how to reduce my pain.	15 (79)	15 (79)
As a result of the [intervention], I am better able to manage/cope with my chronic pain on my own.	12 (63)	11 (58)
If the [intervention] were offered again, I would be interested in coming.	18 (95)	17 (89)
It is likely that I would come for additional [intervention] if offered.	17 (89)	17 (89)
I would recommend [intervention] to other people with pain.	19 (100)	18 (95)
I use what I learned in the pain groups in my daily life.		16 (84)
The pain group helped improve my day-to-day functioning.		15 (79)
The pain group helped improve my quality of life.		14 (74)
The pain groups were supportive to me emotionally.		17 (89)
The group members and leaders treated me with respect.		18 (95)
The pain group was a safe place to discuss difficult issues.		18 (95)
Satisfaction with aspects of the IGMV		Somewhat or completely satisfied
Satisfaction with aspects of the IGMV		n (%)
Movement		17 (89)
Mindfulness		17 (89)
Weekly presentations		18 (95)
Interactions with the providers and clinicians in the pain program		19 (100)
Overall experience with the pain program		18 (95)

Abbreviation: IGMV, integrative group medical visit.

Regarding randomization, 12% of study participants indicated that they were disappointed with their group assignment. Disappointment was proportionally higher among participants randomized to usual care (n = 3, 30%) and acupuncture only (n = 2, 20%) compared with those randomized to IGMV (n = 0). Among those randomized to neither intervention, reasons for disappointment included not being able to contribute more to science and not getting to interact more with the diverse research team, while 1 participant looked forward to accessing acupuncture after completing data collection. One participant who received acupuncture expressed disappointment in not being able to participate in the group mindfulness aspect of the IGMV.

Chronic Pain Experiences

Participants consistently described bidirectional relationships between pain and overall quality of life, including social factors, in interviews, focus groups, and observations of treatment sessions (Table 3). When pain was interfering less with daily life, participants found it possible to connect with neighbors and family members and to consistently engage in health behaviors likely to benefit pain (eg, movement, healthy eating, and mind-body practices). In turn, these kinds of support and daily practices often helped participants’ pain.

Table 3.

Summary of Within-Factor Effects from Integrative Group Medical Visits and Acupuncture.

Outcome	Acupuncture			No acupuncture
	Mean (SE)		Mean (95% CI)	Mean (SE)		Mean (95% CI)
	Baseline	3-month	Change	Baseline	3-month	Change
Pain impact score	35.7 (1.5)	29.5 (1.7)	−6.2 (−9.5, −2.9)	36.5 (1.2)	35.4 (1.8)	−1.1 (−3.8, 1.5)
Average pain intensity	8.0 (0.3)	6.3 (0.5)	−1.7 (−2.6, −0.8)	7.5 (0.4)	7.2 (0.4)	−0.3 (−1.0, 0.5)
Pain interference (PROMIS T-score)	66.8 (1.2)	62.5 (1.5)	−4.3 (−7.0, −1.7)	68.1 (0.9)	66.5 (1.5)	−1.6 (−4.1, 0.9)
Social isolation (PROMIS T-score)	54.5 (1.6)	52.3 (2.3)	−2.2 (−4.7, 0.3)	54.4 (1.4)	55.5 (1.7)	1.1 (−1.7, 4.0)
Internalized stigma in chronic pain	2.5 (0.1)	2.4 (0.1)	−0.1 (−0.4, 0.1)	2.4 (0.1)	2.3 (0.1)	−0.0 (−0.2, 0.1)
Perceived discrimination in healthcare	5.6 (1.1)	6.2 (1.5)	0.6 (−1.7, 3.0)	6.4 (1.0)	7.5 (1.5)	1.1 (−1.5, 3.6)
Anxiety (GAD-2)	4.1 (0.4)	2.6 (0.5)	−1.5 (−2.6, −0.4)	3.3 (0.4)	3.0 (0.4)	−0.3 (−1.0, 0.5)
Depression (PHQ-2)	3.6 (0.4)	2.2 (0.4)	−1.4 (−2.1, −0.6)	2.2 (0.3)	2.4 (0.3)	0.2 (−0.5, 0.8)
Social support in chronic pain	12.2 (1.2)	12.3 (1.3)	0.1 (−2.7, 3.0)	11.2 (1.2)	14.2 (1.1)	3.1 (0.5, 5.6)
Physical function (PROMIS T-score)	37.8 (0.9)	39.9 (1.2)	2.10 (0.3, 3.9)	37.5 (1.1)	38.1 (1.2)	0.6 (−0.8, 2.0)
Global physical health (PROMIS T-score)	31.9 (1.2)	36.7 (1.0)	4.7 (2.1, 7.3)	33.6 (1.4)	35.3 (1.6)	1.7 (−0.6, 4.0)
Global mental health (PROMIS T-score)	33.9 (1.2)	35.8 (1.4)	1.9 (−0.6, 4.4)	36.5 (1.7)	38.2 (1.9)	1.7 (−1.7, 5.0)
Pain self-efficacy score	24.4 (3.1)	30.4 (3.8)	6.1 (−0.1, 12.2)	27.7 (3.3)	28.4 (3.5)	0.7 (−3.0, 4.5)
	Integrative group medical visits			No integrative group medical visits
	Mean (SE)		Mean (95% CI)	Mean (SE)		Mean (95% CI)
	Baseline	3-month	Change	Baseline	3-month	Change
Pain impact score	37.2 (1.2)	33.5 (1.7)	−3.7 (−5.9, −1.6)	35.1 (1.5)	31.6 (1.8)	−3.6 (−7.1, −0.0)
Average pain intensity	7.3 (0.4)	6.6 (0.4)	−0.7 (−1.5, 0.0)	8.1 (0.2)	6.9 (0.4)	−1.2 (−2.1, −0.4)
Pain interference (PROMIS T-score)	68.7 (1.1)	65.7 (1.5)	−3.1 (−5.2, −1.0)	66.4 (1.0)	63.6 (1.5)	−2.9 (−5.8, 0.1)
Social isolation (PROMIS T-score)	54.8 (1.6)	54.4 (2.1)	−0.44 (−3.0, 2.1)	54.1 (1.5)	53.6 (1.9)	−0.6 (−3.5, 2.3)
Internalized stigma in chronic pain	2.5 (0.1)	2.4 (0.1)	−0.1 (−0.3, 0.1)	2.4 (0.1)	2.2 (0.1)	−0.1 (−0.3, 0.1)
Perceived discrimination in healthcare	4.9 (0.9)	7.5 (1.7)	2.6 (−0.5, 5.8)	7.1 (1.1)	6.2 (1.3)	−0.9 (−2.3, 0.4)
Anxiety (GAD-2)	3.7 (0.3)	2.9 (0.4)	−0.8 (−1.5, −0.1)	3.6 (0.4)	2.7 (0.4)	−1.0 (−2.1, 0.1)
Depression (PHQ-2)	3.0 (0.3)	2.6 (0.4)	−0.5 (−1.2, 0.3)	2.7 (0.3)	2.0 (0.4)	−0.7 (−1.4, −0.1)
Social support in chronic pain	11.1 (1.2)	15.1 (1.0)	3.9 (0.7, 7.0)	12.2 (1.2)	11.6 (1.3)	−0.6 (−2.9, 1.6)
Physical function (PROMIS T-score)	36.6 (0.7)	37.5 (1.0)	0.9 (−0.7, 2.4)	38.5 (1.2)	40.3 (1.3)	1.9 (0.2, 3.5)
Global physical health (PROMIS T-score)	33.2 (1.2)	35.6 (1.3)	2.5 (−0.2, 5.1)	32.4 (1.4)	36.3 (1.4)	4.0 (1.7, 6.3)
Global mental health (PROMIS T-score)	34.8 (1.2)	38.0 (1.5)	3.2 (0.1, 6.2)	35.7 (1.6)	36.2 (1.9)	0.4 (−2.4, 3.3)
Pain self-efficacy score	22.8 (3.0)	27.5 (3.5)	4.7 (0.1, 9.2)	29.0 (3.4)	31.1 (3.7)	2.2 (−3.3, 7.6)

Abbreviation: CI, confidence interval; GAD-2, Generalized Anxiety Disorder-2; PHQ-2, Patient Health Questionnaire-2; PROMIS, Patient-Reported Outcomes Measurement Information System.

The top portion of each subtable includes measures for which a score decrease shows improvement, whereas the lower portion of each subtable includes measures for which a score increase shows improvement.

From baseline to post-intervention at 3 months, the mean pain impact score among participants receiving acupuncture decreased by an average of −6.2 (95% CI = −9.5, −2.9). The mean pain impact score decreased by −3.7 (95% CI = −5.9, −1.6) among IGMV participants (Table 4). Notably, the minimal important change in pain impact has been estimated to be a 3-point decrease.⁴² Additionally, the mean pain interference, global physical health, and physical function scores improved among participants receiving either intervention.

Table 4.

Exploratory Analyses of Main Effects of Acupuncture and Integrative Group Medical Visits (IGMVs)^a.

Outcome	Acupuncture vs no acupuncture Mean difference (95% CI)	IGMV vs no IGMV Mean difference (95% CI)
Pain impact score	−5.2 (−9.8, −0.5)**	1.4 (−3.5, 6.2)
Average pain intensity	−1.1 (−2.3, 0.1)*	0.1 (−1.1, 1.3)
Pain interference (PROMIS T-score)	−3.2 (−7.1, 0.7)	0.5 (−3.4, 4.5)
Social isolation (PROMIS T-score)	−3.5 (−7.5, 0.5)*	0.3 (−3.7, 4.3)
Internalized stigma in chronic pain	0.0 (−0.3, 0.3)	0.0 (−0.3, 0.4)
Perceived discrimination in healthcare	−0.4 (−4.2, 3.3)	2.1 (−1.8, 6.0)
Anxiety (GAD-2)	−0.8 (−2.0, 0.5)	0.2 (−1.0, 1.5)
Depression (PHQ-2)	−1.0 (−2.0, 0.1)*	0.4 (−0.6, 1.4)
Social support in chronic pain	−2.4 (−5.9, 1.1)	3.7 (0.2, 7.2)**
Physical function (PROMIS T-score)	1.5 (−0.9, 3.9)	−1.3 (−3.7, 1.2)
Global physical health (PROMIS T-score)	2.3 (−1.0, 5.6)	−1.2 (−4.5, 2.1)
Global mental health (PROMIS T-score)	−0.8 (−5.2, 3.6)	2.4 (−1.9, 6.8)
Pain self efficacy score	3.5 (−4.4, 11.3)	2.4 (−5.3, 10.1)

Abbreviations: IGMV, integrative group medical visit; CI, confidence interval; GAD-2, Generalized Anxiety Disorder-2; PHQ-2, Patient Health Questionnaire-2; PROMIS, Patient-Reported Outcomes Measurement Information System.

Mean differences are estimated using separate ANCOVA models for each outcome listed. The dependent variable for each model was the outcome at follow-up, with indicators for each treatment type (acupuncture and IGMV) as the independent variables, and controlling for the baseline value of the outcome and for language. Effects indicate the difference in change in outcome at follow-up between participants assigned to the listed treatment versus participants not assigned to the treatment, averaged over the other treatment type (in this 2 × 2 factorial trial). Note that this is a main effects analysis and assumes no interaction between the 2 treatments (no interaction term was included in these models). The top portion of the table includes measures for which a score decrease shows improvement, while the lower portion of the table includes measures for which a score increase shows improvement.

Indicates mean differences with P < .10.

Indicates mean differences with P < .05.

We conducted exploratory analyses using ANCOVA to inform the development of our larger study (Table 4). Based on the residualized change from the ANCOVA model, participants who received acupuncture had a 5.2-point greater decrease in their pain impact score at the 3-month follow-up (95% CI = −9.9, −0.6) compared with participants who did not receive acupuncture, controlling for IGMV participation. Using a Fisher’s exact test based on dichotomizing the Global Impression of Change assessment (any improvement vs no change or worsening of symptoms), 86% of participants randomized to a study intervention reported clinically relevant pain improvements compared with 20% of participants randomized to usual care (P < .001).

Social Support, Isolation, and Stigma

Our mixed-methods analysis indicated promising findings related to social support, stigma, and social isolation (Table 5). In interviews and focus groups, several participants shared that they expected to feel “like a guinea pig” while participating in research, but instead experienced the study as the best healthcare they had received. In observations, we noted that IGMV facilitators cultivated a supportive environment, encouraging interactions among peers and modifying therapeutic movement and mind-body practices to accommodate different physical capabilities and preferences for participation. Although acupuncturists did not specifically encourage participant interaction, participants in some group acupuncture sessions spoke to each other at length before and during treatment.

Table 5.

Case Examples of Participant Experiences.

Details of Case Example	Pre-Post Changes in Pain Impact and Social Support
Usual care English cohort, 69-year-old African American woman 20 years of chronic pain, 6 chronic conditions“I loved how diverse the staff was. That made me feel really good. I’m African American. The first person I saw there was an African-American sister, and I loved that. But then, there were all different kinds of people on the inside, and I loved that. . .staff and participants also, I really loved that. . ..I was disappointed that I wasn’t chosen [for an intervention], but it also helped that you all would reach out to me later.”*Note: Data for 3-month social support score was not collected.
Acupuncture English cohort, 59-year-old White genderqueer person 20 years of chronic pain, 1 chronic condition“I really appreciate having a set time and date that I can count on having an acupuncture appointment so I don’t have to keep rescheduling. . .with the set time appointment, I can plan around that. [I felt] more relaxation. Especially the day of, and I felt like the pain was mitigated more on the day of, then it came back over the week. . .I also was receiving acupuncture for depression and anxiety, so that has helped tremendously where I feel more motivated to just do things despite the pain. And I actually wound up getting a couple new dog walking clients, so I’ve got a little more money coming in.”
IGMV + Acupuncture English cohort, 53-year-old White male 8 years of chronic pain, 5 chronic conditions“When I give my opinion [in group], I always see the face of the participant and the [facilitator] react to my words. And I can tell that it’s affecting; it makes sense. And this is giving me a lot of support, that I’m saying something, that it’s [meaningful] for them and it makes sense. . ..Every week we have like one subject, and if you take that pamphlet that [the facilitators] give it to you and you read it at home and you will understand. And sometimes it’s difficult but it really helps. Two days ago, I went outside, nighttime and in a park, and I was doing all this physical movement but in the same time seeing the sky is big and you feel the relief.”
Acupuncture Spanish cohort, 65-year-old Latine man 30 years of chronic pain, 6 chronic conditions“[La acupunctura] fue buena. . .es la cosa de ella, te saluda. Aunque tú no creas, muchos doctores no saludan. . .Yo pienso que ya empieza el enfermo a sentirse un poco mal. Porque, a veces, puede pensar que le está molestando al doctor. . . [la acupuncturista] es muy buena. . ..Se esfuerza para que yo me sienta cómodo con ella.” “The acupuncture was good. The thing about the acupuncturist is, she greets you. Though you wouldn’t believe it, many doctors don’t greet people. . .. I think that makes the sick person start feeling bad. Because sometimes, the person might think they are bothering the doctor. . .The acupuncturist is very good. She tries hard so that I feel comfortable with her.”
IGMV Spanish cohort, 55-year-old Latine woman 2 years of chronic pain, 1 chronic condition“me gusto [el grupo] y ojalá que hagan más de esto, porque la gente, aquí. . .a veces es muy solo. . .Cuando vienen aquí [al grupo], que se desahoga, platican con otras personas, están ahora sí distrayéndose ¿no? . . .Ayuda muchísimo” “I like the group, and I hope they do more of this, because people here are sometimes very alone. . ..When they come here [to the group], they can vent, chat with other people, now they’re distracting themselves, right? It helps so much.”
Acupuncture + IGMV Spanish cohort, 39-year-old Latine transwoman 1 year of chronic pain, 2 chronic conditions[Summary]: This was her first time trying acupuncture, mindfulness and breathing practices, and approaching walking as exercise. She did not attend IGMV and acupuncture very regularly, because she was depressed and struggling to leave the house. When asked if there was anything the team could have done differently to support her attending, she said she appreciated the phone calls reminding her and would have liked people from more clinics to be eligible so that a friend could join with her.

Across intervention arms, participants described how consistent relationships with study team members reduced their social isolation. IGMV participants generally experienced group visits as a supportive environment, in which clinician-facilitators were “on our level.” Many were new to spending time in a group of people living with chronic pain and found their peers to be understanding and encouraging, providing emotional support and practical support for coping with chronic pain (Table 5). Additionally, some participants in each intervention arm shared that improvements in pain and related symptoms allowed them to strengthen their relationships with family, neighbors, and friends.

Participants in all study arms described intersectional stigma in and outside of healthcare settings, which they viewed as related to their pain, as well as other identities (language, socioeconomic status, actual, or perceived substance use). Participants described stigma as substandard care including delayed or inaccurate diagnoses, confusion and tension about pain treatment, and lack of follow-up. Many IGMV participants found that group participation reduced internalized and pain-related stigma. They spoke about benefits of hearing others describe coping with pain, and appreciation for learning new mind-body skills (mindfulness and therapeutic movement) alongside peers. Study team members responded to higher-than-anticipated rates of suicidal ideation and grief after recent family deaths. We referred patients for ongoing mental health care, acupuncture, and other resources. Most participants said they would like to continue receiving care from study clinicians (90%). From baseline to post-intervention, social support for chronic pain increased by an average of 3.9 (95% CI = 0.8, 7.0) on a 24-point scale among IGMV participants. Mean scores for depression and anxiety improved among participants who received acupuncture; anxiety scores improved among IGMV participants (Table 4). Based on the residualized change from the ANCOVA model, IGMV participants had a 3.7-point greater increase in social support for chronic pain compared with participants not randomized to IGMV (95% CI = 0.2, 7.2), controlling for acupuncture participation.

Discussion

We conducted a pilot study of group acupuncture and IGMVs, co-located within safety-net primary care clinics. We tested all research procedures and implementation in English and Spanish in preparation for a larger trial. The results demonstrate feasibility and acceptability of a randomized pragmatic trial in this setting, in ongoing partnership with safety-net clinicians. Mixed-methods data collection provided opportunities to explore experiences of stigma and social support, important social factors in chronic pain that are insufficiently captured through quantitative measures (Table 5).^43,44

This study used best practices to support recruitment and retention of a racially and ethnically diverse population in Spanish and English.^45-47 Study participants were representative of the clinic where the program was offered and included slightly higher percentages of Black and Latine patients and lower percentages of Asian American and White patients than the overall SFHN patient population. Within a long-standing community-academic partnership, our research team combined multiple strategies to address social factors in chronic pain, with the goal of minimizing stigma and providing social support from peers and clinicians facilitating group-based care.

Group-based integrative pain management may be an effective approach to increase access to guideline-concordant pain care. Specifically, group-based approaches can target “social” aspects of biopsychosocial pain care by providing social support for coping with chronic pain and reducing pain-related stigma.^48-50 These social factors are complex and interconnected, but notable shifts occurred for many participants in the 12-week program. Our mixed-methods findings affirm the benefits of continuity of care, peer relationships with others who have chronic pain, and supportive interactions with clinicians and peers. Social support is multi-faceted, and participants described increased social support in daily life and within the program, which aligns with prior findings on group visits.^14,15 Pilot data support the expanded use of group-based care to increase access to multimodal treatment, address time constraints that contribute to disparities in pain management, and foster social connectedness and belonging. Because this pilot study was designed to test feasibility and was not powered for effectiveness, we report between-group analyses for transparency but cannot draw inferences from them. However, in within-group analyses, the direction of change suggests improvement across a range of patient-reported outcomes, and preliminary estimates from between-group exploratory analyses were overall consistent with support for these programs.

Group-based treatment is offered in a growing number of community health centers and other settings and provides a feasible way to increase access to care while providing multiple social benefits. Future research should explore approaches to multimodal care in primary care settings. We are currently conducting a large, randomized trial of IGMVs and group acupuncture, offering usual care participants the option to choose an intervention after 6-month follow up.²⁹ This study tests the hypotheses that assignment to group acupuncture or IGMV will improve pain outcomes and social support in participants with chronic pain. Additionally, we are evaluating multilevel effects of increasing access to multimodal pain care in a network of safety-net primary care clinics.

The United States has a long history of inequity in chronic pain care, with racism, economic segregation of health care, and gender-based discrimination shaping who has access to guideline-concordant pain care.⁵¹ Opioid prescribing in primary care and elsewhere has notably decreased in recent years, without corresponding investments in guideline-concordant, multimodal chronic pain care.^52,53 Widespread access to guideline-concordant care is an important form of institutional repair given the common undertreatment of chronic pain among Black and Latine individuals, women, and individuals with low incomes.^18-20 Safety-net primary care clinics are a key setting for growing efforts to increase equitable access to group-based, biopsychosocial care.^54,55 Now that treatment guidelines recommend a pain management approach that is both biopsychosocial and multimodal, including non-pharmacologic therapies, commitment is required to ensure a shift toward equitable care.

Footnotes

Acknowledgements

The authors thank the many people who have contributed to the San Francisco Health Network’s Integrative Pain Management Program (IPMP), including the IPMP Steering Committee, integrative health practitioners, primary care and behavioral health clinicians, San Francisco Department of Public Health primary care leadership, research staff, study consultants, and all the patients who have participated in the program. Special thanks to the pilot study clinicians and research team: Melissa Craven, LAc, Victoria Garcia Drago, BA, Annika Hansen, MA, Sudha Prathikanti, MD, Vadan Ritter, LAc, Nakarí Ron, LCSW, Denise Ruvalcaba, BA, Naomi Schoenfeld, MS, PhD, and Antonella Soldaini, LAc. We also thank the Castro-Mission Health Center leadership and staff, especially Keith Seidel, MD, and Lilibeth Morales, MBA.

Author Note

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

ORCID iDs

Ariana Thompson-Lastad

Maria T. Chao

Ethical Considerations

This study was approved by the University of California San Francisco (UCSF) Institutional Review Board (#22-37078) on August 2, 2022.

Consent to Participate

All participants provided written informed consent prior to participating.

Consent for Publication

Not applicable.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Research reported in this publication was supported by the HEAL Initiative Advancing Health Equity in Pain Management Program, National Institute on Minority Health and Health Disparities (NIMHD) and the National Institute of Neurological Disease and Stroke (NINDS) of the National Institutes of Health (NIH) under Award Numbers R61MD018333, R33MD018333, and K01MD015766.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data Availability Statement

Data and data collection tools from this study are available by request, and will be available through the ICPSR data repository.

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Group-Based Integrative Pain Management: Feasibility of a Factorial Randomized Trial in Safety-Net Primary Care

Abstract

Purpose:

Methods:

Results:

Conclusion:

Keywords

Introduction

Methods

Study Design

Study Procedures

Measures

Quantitative

Qualitative

Data Analysis

Quantitative

Qualitative

Results

Study Participants

Feasibility of Study Procedures

Study Acceptability

Chronic Pain Experiences

Social Support, Isolation, and Stigma

Discussion

Footnotes

Acknowledgements

Author Note

ORCID iDs

Ethical Considerations

Consent to Participate

Consent for Publication

Funding

Declaration of Conflicting Interests

Data Availability Statement

References