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Acupressure in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupressure
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Acupressure, AcuWand, MeTime

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient is being treated for Rheumatoid Arthritis (RA) at a Rheumatology Clinic at the University of Michigan.
  • Patient reports being on medications prescribed from a rheumatologist specifically for their RA.

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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acupressure

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility of self-performed acupressure in patients with RA assessed by the number of sessions completed
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).

Secondary Outcome Measures

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).
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.

Full Information

First Posted
June 6, 2022
Last Updated
August 1, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05412121
Brief Title
Acupressure in Rheumatoid Arthritis
Official Title
Feasibility and Acceptability of Acupressure in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Acupressure, AcuWand, MeTime

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupressure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of self-performed acupressure in patients with RA assessed by the number of sessions completed
Time Frame
up to day 42 (during acupressure)
Title
Acceptability of self-performed acupressure in patients with RA assessed by Acupressure Tolerability Scale at day 42
Description
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).
Time Frame
Day 42 (during acupressure)
Secondary Outcome Measure Information:
Title
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2)
Description
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).
Time Frame
Baseline to Day 42
Title
Change in Fibromyalgia Survey Questionnaire
Description
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.
Time Frame
Baseline to Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Scott
Phone
734-998-7022
Email
jrsj@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Murphy, MD
Phone
734-232-1697
Email
aemurph@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Murphy, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Murphy, MD
Phone
734-232-1697
Email
aemurph@umich.edu
First Name & Middle Initial & Last Name & Degree
Anne Murphy, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Acupressure in Rheumatoid Arthritis

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