Acupressure in Rheumatoid Arthritis

Study Overview
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Brief Summary
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The goal of this pilot trial is to better understand if acupressure is feasible and tolerable to people with rheumatoid arthritis.

Official Title
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Feasibility and Acceptability of Acupressure in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Device: Acupressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patient is being treated for Rheumatoid Arthritis (RA) at a Rheumatology Clinic at the University of Michigan or another by rheumatologist and reports being prescribed at least one of the following medications: Methotrexate (Trexall, Rheumatrex) Hydroxychloroquine (Plaquenil) Sulfasalazine (Azulfadine) Leflunomide (Arava) Tocilizumab (Actemra) Tumor necrosis factor inhibitor (TNFi), including: Adalimumab (Humira) Etanercept (Enbrel) Certolizumab pegol (Cimzia) Golimumab (Simponi) Infliximab (Remicade) Abatacept (Orencia) Tocilizumab (Actemra) Janus kinase inhibitor (JAKi), including: Tofacitinib (Xeljanz) Baracitinib (Olumiant) Upadacitinib (Rinvoq) o Rituximab (Rituxan) Exclusion Criteria: Visual or hearing difficulties that would preclude participation, Do not speak or read English Do not have access to smart phone with access to mobile applications Severe psychiatric disorders including history of substance abuse disorders, Individuals on high doses of opioids (over 100 oral morphine equivalents) Taking blood thinners, including warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa) Thrombocytopenia (low platelet count) Expecting to receive surgery within the next year for their RA Pregnancy or breast feeding, or anticipate pregnancy in next year, Actively applying for disability or compensation, or actively involved in litigation. Anything at the discretion of the principal investigator or study team

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupressure<br>The self-acupressure intervention will be delivered using the modified MeTime Acupressure mobile application (App) in addition to in-person or virtual instruction via study staff. | Device: Acupressure<br>* The MeTime Acupressure app will be loaded onto computer tablets or smart phones by the participants. Participants will also receive an AcuWand to be used in association with the acupressure app to help participants apply the correct amount of pressure to acupoints. There are 9 acupressure points, totaling 27 minutes of stimulation per day. Participants will perform daily acupressure for a total of six weeks. In addition all participants will complete a battery of validated questionnaires before, during and after completion of treatment intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of self-performed acupressure in patients with RA assessed by the number of sessions completed |  | up to day 42 (during acupressure) | 
| Acceptability of self-performed acupressure in patients with RA assessed by Acupressure Tolerability Scale at day 42 | This scale has 4 questions for participants to complete; 1) were able to perform acupressure for the required time each day (0-10 scale with 0 being 'not at all' and 10 being 'all of the time'); 2) a question asking if participants had to stop performing acupressure at any point (0-10 scale with 0 being 'not at all' and 10 being 'all of the time'); 3) a question asking if acupressure was stopped, was it because pain in the hands (yes or no); 4) and a question asking if acupressure was stopped, was it because pain at the acupoint - the place on the body where pressure is being applied (yes or no). | Day 42 (during acupressure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function on a scale of 1 (worst) to 5 (best), and pain intensity (on a scale ranging from 0 (no pain) to 10 (worst pain imaginable). | Baseline to Day 42 | 
| Change in Fibromyalgia Survey Questionnaire | The fibromyalgia survey questionnaire comprises a measure of widespread body pain (0-19 points; one point per body location) and an assessment of comorbid symptoms (0-12 points including fatigue/depression/sleep/cognition) for a total possible score of 0-31. The typical score of 13 or higher is needed for the Fibromyalgia diagnosis. This can arise from multiple combinations of the widespread pain and symptom severity scores. | Baseline to Day 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupressure, AcuWand, MeTime