Group Acupuncture Therapy With Yoga Therapy for Chronic Neck, Low Back, and Osteoarthritis Pain in Safety Net Settings for an Underserved Population: A Feasibility Pilot Study

Study Design

The study used a repeated measures quasi experimental design comparing baseline measures to those at 10 weeks and 24 weeks from baseline. To optimize feasibility and acceptability to patients and participating health centers while still generating meaningful outcome data, we did not randomize within the practices, but instead offered the intervention to all patients who met eligibility criteria. To collect pre-acupuncture assessments of pain, we included a 10-day intake run-in period prior to the initial acupuncture session that ensures treatment within a time frame that is consistent with typical time to appointments for many consultations (see Table 1 below). Study was approved by all IRBs, specifically those of Albert Einstein College of Medicine, Montefiore Medical Center; Institute for Family Health; and Icahn School of Medicine at Mount Sinai.

Study Participants and Eligibility

Outpatients with chronic pain were receiving primary care at multiple Institute for Family Health (IFH) community health center sites in Manhattan and the Bronx, and two Montefiore Medical Group (MMG) sites in the Bronx: The Family Health Center and Williamsbridge Family Practice Center. Eligibility for participants included:

• • 21 years of age or older

• • Chronic pain (3 months or more in duration) due to a qualifying diagnosis of back pain, neck pain, and/or osteoarthritis.

• • Ability to provide consent in English or Spanish

• • Reliable phone contact

• • Availability for up to 10 weekly consecutive treatments and follow-up data collection up to 24 weeks.

Exclusion criteria were

• • Recent acupuncture treatment or yoga instruction/therapy in the 6 months prior to recruitment

• • Pregnancy

• • Severe psychiatric problems as assessed by the study team (e.g., chronic interpersonal problems, cognitive impairment or active psychosis that is uncontrolled by medication that precludes the ability to provide informed consent or complete the survey instruments).

Recruitment

Primary care providers at the IFH and MMG sites made referrals to the study team by paper referral or electronic medical record in-basket. Referring providers obtained verbal permission from the patient for a Clinical Research Coordinator (CRC) to contact them. The CRC confirmed patient eligibility and consent orally over the phone to be reviewed and confirmed in person. Participants did not receive an incentive to attend treatment sessions but did receive modest incentives to complete the research interviews. Participants were provided $25 for completing the enrollment interview, $5 for completing the Run-in 1 interview (and $5 for subsequent run-in interviews, if necessary), and $15 for completing the treatment initiation interview before the first intervention session. After the intervention, participants were provided $25 and $30 for completing study interviews at Week 10 and Week 24, respectively (Table 1 shows the interval of assessments).

Intervention

IFH patients received the intervention at the Family Health Center of Harlem, while Montefiore patients received the intervention at the two Bronx MMG sites. Treatment consisted of ten consecutive weekly group acupuncture therapy treatments described in detail in a previous design paper ²¹ and intervention manualization. ⁵⁶ Yoga therapy treatments were started at week 3 and consisted of eight consecutive yoga therapy sessions that occurred immediately after acupuncture, in an adjacent room.

Usual Care

During the entire study, patients continued to receive usual care for management of chronic pain as provided by primary care providers. Usual care may include referral for specialty consultation or physical therapy, or use of medication, but does not typically include acupuncture or yoga services. We anticipated that patients would vary substantially in the duration and severity of pain and the specifics of the approach to pain management.

Acupuncture Therapy Component

During the intervention phase, each participant was given acupuncture therapy in a group setting (seated in a stationary chair) over 10 consecutive weeks. Direct practitioner/patient session time typically lasted 30-40 minutes. Session time could reach up to 60 minutes, to include time for the participants to arrive and settle in, as well as rest time after treatment. Sessions were shortened to as little as 15 minutes if participants were late to their scheduled treatment time. Three consecutive weekly sessions of acupuncture were given before yoga therapy was introduced. This allowed time for acupuncture therapy to reduce chronic pain severity, readying the participant to begin an active phase of movement and recovery provided by yoga therapy. Thereafter, patient appointments were arranged so that acupuncture treatment immediately preceded yoga therapy treatment on the same day.

Yoga Therapy Component

At week 2, a 20-25-minute yoga intake was conducted, following acupuncture therapy, to assess and inform a yoga plan of care. At week 3, that plan of care introduced the yoga therapy following the acupuncture therapy, so that week’s 3 through 10 were combined sequential interventions, as stated above. Participants’ yoga therapy sessions lasted 30-35 minutes, either individually or in dyads. To foster self-efficacy and sustained benefit, participants were further directed to practice at home via simple instructions both verbally and with handouts in patient’s preferred language of English or Spanish. Participants were guided in the yoga philosophy of mindful awareness and non-harming in order to avoid exacerbation of symptoms and ensure optimal safety in home practice.

Sample Size Calculations

Using an alpha of .05, two tailed, a power of .80, and a clinically meaningful change defined as a 30% improvement on the BPI, we estimated that we needed approximately 134 participants treated through the GAPYOGA trial. To account for attrition we based our assessment on the AADDOPT-2 trial where we had complete data at 12 weeks for 84% of the participants. Therefore, for this trial we planned to recruit 150 participants. That said, on March 13, 2020, due to the onset of the COVID pandemic, recruitment and intervention for our study was terminated, with an enrollment of 93; as a result, our power was reduced to 74%.

Quantitative Analysis

Prior to any univariate or multivariate analysis, all data was reviewed to make sure values were in range and that outliers did not reflect typographical or data entry problems. Missing responses for any index measure were imputed using the average values from completed measures within the same index. Data was described univariate at baseline, 10 weeks and 24 weeks to assess loss to follow-up. Each primary and secondary outcome, pain interference and pain severity, were examined separately using repeated measures t-tests.

Retention, Feasibility and Engagement

There were 467 referrals received from medical providers over the recruitment period. Of these, 93 patients were determined to be eligible and completed the baseline interview. Seventy-eight (84%) of the 93 participants completed the intervention and 10-week interview. Fifty-eight (62% from baseline) completed the 24-week post intervention survey. There was no statistically significant difference in socio-demographics between those participants lost to follow up (either through attrition or the impact of the pandemic) vs study completers (data not shown). Participants received an average number of 6.5 acupuncture sessions (out of a possible 10), and 4 yoga sessions (out of a possible 8) over the 10-week intervention. At baseline, participants’ average age was 54 years, with the majority of participants being female (Table 2). A significant proportion (47.3%) of participants identified as Black or Hispanic (44.1%). Medicaid insurance coverage represented the majority of participants (63.4%), identifying the research population as underserved. At Week-10 and Week-24 the proportions remain similar despite the loss of participants. Participants had high acceptance as reported in our previous trial and our qualitative study.^39,43 While not measured by survey, referring primary care providers reported enthusiasm that was also reflected in their level of referral.

Primary Outcomes

Both pain interference and pain severity show statistically significant improvement from baseline to 10-weeks (mean difference -2.1, P < .01) and baseline to 24-weeks (mean difference −1.62, P < .01) (Figure 1). Improvement was strongest from baseline to 10-weeks, at the close of the intervention. While improvement diminished somewhat at 24-week post intervention, significant improvement was maintained. In regard to pain responsiveness, using a 30% decrease as the benchmark for clinically meaningful improvement, at the 10-week end of intervention period, over one-third of the patients showed a 30% or greater improvement in both pain interference (37.5%) and pain severity (38.7%) (See Figure 2). At the 24-week follow-up, this proportion decreased to 25% for pain interference and 16% for pain severity.

Secondary Outcomes

Pain-free days and general pain showed a similar pattern of greatest improvement at 10-weeks with a reduction of effect at 24-weeks but still maintenance of significant improvement from baseline. Average pain and patient impression of physical change (PCIG Physical) showed significant improvement from baseline to the 10-week term of the intervention. However, by 24-weeks these improvements nullified. The patient impression of mental change (PCIG Mental), and engagement (ACE inform) showed no significant improvement at 10-weeks, but at the 24-week follow-up these showed significant improvements from baseline. The PROMIS 10 and PROMIS Satisfaction showed no significant change over the study period.

Adverse Events

There were no serious events during the course of this study. There were four minor adverse events: dizziness during an acupuncture session, retained needle from acupuncture (but discovered by yoga therapist), worsening of leg pain attributed to acupuncture by the participant, and dizziness and weakness after intervention attributed by participant to intervention. Our experience is in line with the safety literature for acupuncture therapy^70,71 and yoga.^72,73

Limitations

Factors associated with implementing bundled therapies at health centers that care for underserved populations are discussed in a separate paper. ⁷⁹ Study challenges included difficulty reaching lower socioeconomic participants by telephone during recruitment, and site coordination to integrate group acupuncture with yoga therapy. In addition, the COVID pandemic caused the study to be stopped early before full recruitment could be achieved. The pandemic may also have added to difficulties in obtaining follow-up assessments at 24-weeks because of the overall disruption in participants’ lives during that time. Our study did not have a control group and so we could not assess whether the addition of yoga to acupuncture definitively added to treatment effect, i.e., provided synergy. Lastly, we were not able to assess feasibility associated with cost. However, even in the face of these limitations we did see significant improvement in our primary outcome measures. Lessons learned bundling care will help to inform the design and methodology of a larger pragmatic trial.

Conclusion

Access to nonpharmacologic pain care is minimal in low-resource medical centers; medical providers are seeking effective pain care options in light of the opioid crisis and welcome the ability to refer for effective nonpharmacologic options. Group acupuncture therapy was effective in our previous trial and was highly acceptable to patient participants as well as medical providers who referred patients. ³⁹ Yoga therapy is also beneficial for chronic pain. Combining these therapies also appeared to be highly acceptable to both referring providers and patient participants. In addition, bundling these therapies at a participant’s primary care site may offer significant access benefit for patients. Further study in combining acupuncture and yoga therapy for chronic pain is warranted.

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Trial Approved by Institution Review Boards (IRB)

Albert Einstein College of Medicine, Montefiore Medical Center IRB #2018-9015, Ref: # 059397; Institute for Family Health IRB # 2297; and Icahn School of Medicine at Mount Sinai IRB #18-00607.