Acupressure in Rheumatoid Arthritis

NCT ID: NCT05412121

Last Updated: 2024-05-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2023-07-20

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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Acupressure

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Anne Murphy

House Officer, Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HUM00206002

Identifier Type: -

Identifier Source: org_study_id

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