Clinical trial NCT04296344: Group Acupuncture Therapy With Modified Yoga
Official title: Group Acupuncture Therapy With Modified Yoga for Chronic Neck, Low Back and OA Pain in Safety Net Setting for an Underserved Population (GAPYOGA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Chronic Low Back Pain
Osteoarthritis Pain
Keywords: Acupuncture therapy
Yoga therapy
Integrative medicine
Chronic pain
Underserved
Safety net setting
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: The Institute for Family Health
name: Albert Einstein College of Medicine
name: Maryland University of Integrative Health
First posted: 2020-03-05
Enrollment: 94
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic pain is prevalent in the U.S., with impact on physical and psychological functioning as well as lost work productivity. Minority and lower socioeconomic populations have increased prevalence of chronic pain with less access to pain care and poorer outcomes. Acupuncture therapy is effective in treating chronic pain conditions including chronic low back pain (cLBP), neck pain, shoulder pain and knee pain from osteoarthritis (OA). Acupuncture therapy, including group acupuncture, is feasible and effective, and specifically so for underserved and diverse populations at risk for health outcome disparities. Acupuncture therapy also encourages patient engagement and activation. As chronic pain improves there is a natural progression to want and need to increase activity and movement recovery. Diverse movement approaches are important both for improving range of motion, maintaining gains, strengthening and promoting patient engagement and activation. Yoga therapy is an active therapy with proven benefit in musculoskeletal pain disorders and pain associated disability. The aim of this pilot feasibility trial is to test the bundling of these two care options for chronic pain, to inform both the design for a larger randomized pragmatic effectiveness trial as well as implementation strategies across underserved settings.

Detailed description: The goal of this project is to assess the feasibility of a low-cost, integrative intervention for chronic pain that can be replicated and implemented in underserved medical settings across the U.S. Over the course of 18 months, the study team will recruit at least 150 outpatients with chronic pain from the Institute for Family Health (IFH) Family Medicine sites and Montefiore Medical Group sites, both Federally Qualified Health Centers (FQHCs). Treatment will consist of ten consecutive weekly group acupuncture therapy treatments. Yoga therapy treatments will start at week three and will consist of eight consecutive yoga therapy sessions that occur immediately following in a room adjacent to acupuncture therapy. Sessions are bundled to facilitate attendance that might be affected by two separate trips a week for participation. The primary outcome will be pain interference and pain intensity. Secondary outcomes will be pain free days, depression, functional status, patient activation, and pain medication utilization. These will be used during the pre-intervention phase, during which patients are receiving usual care only, and compared to the period after patients receive the combined acupuncture and yoga sessions. Data will be collected for 10 days before acupuncture and yoga therapy, and up to 24 weeks following the end of treatment.

The study will use a 'multiple settings across baseline' quasi-experimental design. This is a repeated measures design, and each study participant will have multiple pre- and post-measures. The multiple pre-measurement points allows the study team to document and monitor what may be variable patterns of pain pre-intervention. This design optimizes feasibility and acceptability to patients and participating health centers while still generating meaningful outcome data. Specifically, the study team has not proposed randomization within the practices, rather allowing sites to offer the intervention to all patients with target diagnoses who meet eligibility criteria. To collect pre-acupuncture assessments of pain, the study team will include 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.

Eligibility criteria: Inclusion Criteria:

* Patients 21 years of age or older
* Chronic pain (three months or more in duration) due to a qualifying diagnosis of back pain, neck pain, and/or osteoarthritis.
* Eligible patients must be receiving primary care at a participating IFH or Montefiore Medical Group site
* Participants must understand and be able to provide consent in English or Spanish
* Reliable contact phone numbers must be available to facilitate scheduling,
* Availability for up to 10 weekly consecutive treatments and
* Availability for follow-up data collection at 24 weeks

Exclusion criteria:

* Receipt of 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)

Primary outcomes:
measure: Change in Brief Pain Inventory: Short Form
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change in Pain Free Days
timeFrame: Baseline and Week 24
measure: Change in Center for Epidemiological Studies - Depression Scale (CES-D)
timeFrame: Baseline and Week 24
measure: Change in Altarum Consumer Engagement (ACE)
timeFrame: Baseline and Week 24
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS 10)
timeFrame: Baseline and Week 24
measure: Change in PROMIS Satisfaction with Participation in Social Roles (PROMIS-SF)
timeFrame: Baseline and Week 24
measure: Change in Patient Global Impression of Change (PGIC)
timeFrame: Week 10 and Week 24
measure: Change in Medication Utilization
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Family Health Center
state: New York
city: Bronx
country: United States
facility: Williamsbridge Family Practice Center
state: New York
city: New York
country: United States
facility: The Institute For Family Health
state: New York
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Raymond Teets, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson BJ, Meissner P, Mah DM, Nielsen A, Moonaz S, McKee MD, Kligler B, Milanes M, Guerra H, Teets R. Barriers and Facilitators to Implementing Bundled Acupuncture and Yoga Therapy to Treat Chronic Pain in Community Healthcare Settings: A Feasibility Pilot. J Altern Complement Med. 2021 Jun;27(6):496-505. doi: 10.1089/acm.2020.0394. Epub 2021 Mar 15.