Group Acupuncture Therapy With Modified Yoga

NCT04296344 | Completed

• 2 other identifiers: GCO 18-124002855405
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Neck Pain; Chronic Low Back Pain; Osteoarthritis Pain

Keywords

Acupuncture therapy; Yoga therapy; Integrative medicine; Chronic pain; Underserved; Safety net setting

Outcome Measures

Primary Outcomes (1)

• Change in Brief Pain Inventory: Short Form

  The BPI is a nine-item measure which that asks patients to indicate how their pain influences function: select aspects of their everyday life including mood, walking, sleep and their ability to work over the past 24 hours, as well as the level and intensity of pain. This measure will be adapted for use by phone, modifying a question which asks participants to refer to a diagram of the body. total score from 0 to 10, with higher score indicating worse outcomes.

  Baseline and Week 24

Secondary Outcomes (7)

• Change in Pain Free Days

  Baseline and Week 24

• Change in Center for Epidemiological Studies - Depression Scale (CES-D)

  Baseline and Week 24

• Change in Altarum Consumer Engagement (ACE)

  Baseline and Week 24

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS 10)

  Baseline and Week 24

• Change in PROMIS Satisfaction with Participation in Social Roles (PROMIS-SF)

  Baseline and Week 24

Study Arms (1)

Treatment

EXPERIMENTAL

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

Other: Acupuncture Therapy Treatments; Other: Yoga Therapy Sessions

Interventions

Acupuncture Therapy Treatments OTHER

10 consecutive weekly group acupuncture therapy treatments

Treatment

Yoga Therapy Sessions OTHER

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

Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• The Institute for Family Health: collaborator
• Albert Einstein College of Medicine: collaborator
• Maryland University of Integrative Health: collaborator

Study Sites (3)

The Institute For Family Health

New York, New York, 10035, United States

Location

Montefiore Family Health Center

The Bronx, New York, 10458, United States

Location

Williamsbridge Family Practice Center

The Bronx, New York, 10469, United States

Location

Related Publications (1)

• 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.

  PMID: 33720749 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Raymond Teets, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Family Medicine

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: January 8, 2019
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.Any purpose.Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).

Locations

US (3)