Acupressure in Rheumatoid Arthritis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 25 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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) - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05412121
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Michigan
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Anne Murphy, MD
Principal Investigator Affiliation University of Michigan
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Michigan, Ann Arbor, Michigan

Status

Recruiting

Address

University of Michigan

Ann Arbor, Michigan, 48109

Site Contact

Anne Murphy, MD

[email protected]

734-232-1697