An interventional study of Acupuncture Therapy Treatments and Yoga Therapy Sessions in Chronic Neck Pain, Chronic Low Back Pain and Osteoarthritis Pain, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 3 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion criteria:
Participants with chronic pain to receive acupuncture therapy treatments and yoga therapy sessions.
Other: Acupuncture Therapy Treatments · Other: Yoga Therapy Sessions
10 consecutive weekly group acupuncture therapy treatments
8 consecutive yoga therapy sessions that occur immediately following in a room adjacent to acupuncture therapy.
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.
Time frame: Baseline and Week 24
Change in Pain Free Days
Self-report measure to report the number of pain free days in the previous 2 weeks. This measure will be used pre- and post-intervention.
Time frame: Baseline and Week 24
Change in Center for Epidemiological Studies - Depression Scale (CES-D)
This is a well-validated, 20-item measure of depressive symptoms. This will be used both at the initiation treatment interview and the end of the study. Full score from 0- 20, with higher score indicating more symptomology.
Time frame: Baseline and Week 24
Change in Altarum Consumer Engagement (ACE)
A 12-item measure that assesses three domains of health engagement: commitment, informed choice, and navigation. The measure covers areas not included in other surveys and it is a good predictor of current health status, lifestyle health behaviors, medication adherence, and how likely it is that people will use tools to support their decisions. This measure will be adapted to include 8 of the 12 items on the questionnaire. Full scale from 0-100, higher score indicates higher consumer engagement.
Time frame: Baseline and Week 24
Change in Patient-Reported Outcomes Measurement Information System (PROMIS 10)
A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Time frame: Baseline and Week 24
Change in PROMIS Satisfaction with Participation in Social Roles (PROMIS-SF)
is a 14-item measure that is part of the PROMIS Social Function. The measure refers to social roles, such as work and family responsibilities, and more discretionary social activities, such as leisure activity and relationships with friends. standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Time frame: Baseline and Week 24
Change in Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC) is a single question 7-point categorical scale that captures a patient's experience of treatment at follow-up points, after all sessions are completed. Full score from 0-7, with higher score indicating more improvement.
Time frame: Week 10 and Week 24
Change in Medication Utilization
Participants will be asked to report their use of pain medications over the prior one-week period.
Time frame: Baseline and Week 24
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Icahn School of Medicine at Mount Sinai