Group Acupuncture Therapy With Modified Yoga

NCT ID: NCT04296344

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2020-11-11

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.

Conditions

Chronic Neck Pain; Chronic Low Back Pain; Osteoarthritis Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Participants with chronic pain to receive acupuncture therapy treatments and yoga therapy sessions.

Group Type: EXPERIMENTAL

Acupuncture Therapy Treatments

Intervention Type: OTHER

10 consecutive weekly group acupuncture therapy treatments

Yoga Therapy Sessions

Intervention Type: OTHER

8 consecutive yoga therapy sessions that occur immediately following in a room adjacent to acupuncture therapy.

Interventions

Acupuncture Therapy Treatments

10 consecutive weekly group acupuncture therapy treatments

Intervention Type: OTHER

Yoga Therapy Sessions

8 consecutive yoga therapy sessions that occur immediately following in a room adjacent to acupuncture therapy.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Institute for Family Health

OTHER

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

Maryland University of Integrative Health

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Raymond Teets

Assistant Professor, Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raymond Teets, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

The Institute For Family Health

New York, New York, United States

Montefiore Family Health Center

The Bronx, New York, United States

Williamsbridge Family Practice Center

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33720749 (View on PubMed)

Other Identifiers

02855405

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GCO 18-1240

Identifier Type: -

Identifier Source: org_study_id