Acupressure in Rheumatoid Arthritis

November 13, 2023 updated by: Anne Murphy, University of Michigan

Feasibility and Acceptability of Acupressure in Patients With Rheumatoid Arthritis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
Time Frame: up to day 42 (during acupressure)
up to day 42 (during acupressure)
Acceptability of self-performed acupressure in patients with RA assessed by Acupressure Tolerability Scale at day 42
Time Frame: 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).
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)
Time Frame: 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).
Baseline to Day 42
Change in Fibromyalgia Survey Questionnaire
Time Frame: 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.
Baseline to Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Anne Murphy, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Actual)

July 14, 2023

Study Completion (Actual)

July 20, 2023

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 9, 2022

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00206002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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