Acupressure in Rheumatoid Arthritis

NCT05412121 | Completed Results FDA Device

• 1 other identifier: HUM00206002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Acupressure; AcuWand; MeTime

Outcome Measures

Primary Outcomes (5)

• Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed

  Feasibility of self-performed acupressure in patients with rheumatoid arthritis assessed by the number of study sessions completed by participants. Results reflect the number of participants who responded to all of the surveys administered at the Day 42 visit.

  up to day 42 (during acupressure)

• Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 1

  The Acupressure Tolerability Scale was comprised of 4 questions for participants to complete. Each question used a different scoring method, so the questions are reported as separate outcomes. Question 1 asked whether participants were able to perform acupressure for the required time each day. Responses were on a 0-10 scale with 0 being 'not at all' and 10 being 'all of the time.'

  Day 42 (during acupressure)

• Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 2

  The Acupressure Tolerability Scale was comprised of 4 questions for participants to complete. Each question used a different scoring method, so the questions are reported as separate outcomes. Question 2 asked whether participants had to stop performing acupressure at any point during administration. Responses were on a 0-10 scale with 0 being 'not at all' and 10 being 'all of the time.'

  Day 42 (during acupressure)

• Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 3

  The Acupressure Tolerability Scale was comprised of 4 questions for participants to complete. Each question used a different scoring method, so the questions are reported as separate outcomes. Question 3 asked whether participants stopped acupressure because of pain in the hands. Responses could either be Yes or No. The results represent the number of participants who responded 'Yes' to this question.

  Day 42 (during acupressure)

• Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 4

  The Acupressure Tolerability Scale was comprised of 4 questions for participants to complete. Each question used a different scoring method, so the questions are reported as separate outcomes. Question 4 asked whether participants stopped acupressure because of pain at the acupoint, i.e., the place on the body where pressure was being applied. Responses could either be Yes or No. The results represent the number of participants who responded 'Yes' to this question.

  Day 42 (during acupressure)

Secondary Outcomes (9)

• Change in Fibromyalgia Survey Questionnaire

  Baseline to Day 42

• Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Physical Functioning

  Baseline to Day 42

• Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Anxiety

  Baseline to Day 42

• Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Depression

  Baseline to Day 42

• Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Fatigue

  Baseline to Day 42

Study Arms (1)

Acupressure

EXPERIMENTAL

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

Interventions

Acupressure 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.

Acupressure

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Anne Murphy
• Organization: University of Michigan

aemurph@med.umich.edu

734-936-5566

Study Officials

• Anne Murphy, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: House Officer, Internal Medicine

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: September 15, 2022
• Primary Completion: July 14, 2023
• Study Completion: July 20, 2023
• Last Updated: May 9, 2024
• Results First Posted: May 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)