Clinical trial NCT05412121: Acupressure in Rheumatoid Arthritis
Official title: Feasibility and Acceptability of Acupressure in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Acupressure
AcuWand
MeTime
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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)
* 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

Primary outcomes:
measure: Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed
timeFrame: up to day 42 (during acupressure)
measure: Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 1
timeFrame: Day 42 (during acupressure)
measure: Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 2
timeFrame: Day 42 (during acupressure)
measure: Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 3
timeFrame: Day 42 (during acupressure)
measure: Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 4
timeFrame: Day 42 (during acupressure)
Secondary outcomes:
measure: Change in Fibromyalgia Survey Questionnaire
timeFrame: Baseline to Day 42
measure: Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Physical Functioning
timeFrame: Baseline to Day 42
measure: Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Anxiety
timeFrame: Baseline to Day 42
measure: Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Depression
timeFrame: Baseline to Day 42
measure: Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Fatigue
timeFrame: Baseline to Day 42
measure: Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Sleep Disturbance
timeFrame: Baseline to Day 42
measure: Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Social Participation
timeFrame: Baseline to Day 42
measure: Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Pain Interference
timeFrame: Baseline to Day 42
measure: Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Cognitive Function
timeFrame: Baseline to Day 42
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Anne Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References: