Acupressure in Rheumatoid Arthritis
Study Details
Study Description
Brief Summary
The goal of this pilot trial is to better understand if acupressure is feasible and tolerable to people with rheumatoid arthritis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acupressure 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
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.
|
Outcome Measures
Primary Outcome Measures
- 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 [Day 42 (during acupressure)]
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).
Secondary Outcome Measures
- Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) [Baseline to Day 42]
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).
- Change in Fibromyalgia Survey Questionnaire [Baseline to Day 42]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is being treated for Rheumatoid Arthritis (RA) at a Rheumatology Clinic at the University of Michigan.
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Patient reports being on medications prescribed from a rheumatologist specifically for their RA.
Exclusion Criteria:
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Visual or hearing difficulties that would preclude participation,
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Do not speak or read English
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Do not have access to smart phone with access to mobile applications
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Severe psychiatric disorders including history of substance abuse disorders,
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Individuals on high doses of opioids (over 100 oral morphine equivalents)
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Taking blood thinners, including warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)
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Thrombocytopenia (low platelet count)
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Expecting to receive surgery within the next year for their RA
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Pregnancy or breast feeding, or anticipate pregnancy in next year,
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Actively applying for disability or compensation, or actively involved in litigation.
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Anything at the discretion of the principal investigator or study team
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Anne Murphy, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00206002