N/A
N=14
Acupressure in Rheumatoid Arthritis
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT05412121 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupressure (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed |
6 | — |
| PRIMARY Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 1 |
7 | — |
| PRIMARY Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 2 |
4 | — |
| PRIMARY Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 3 |
2 | — |
| PRIMARY Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 4 |
1 | — |
| SECONDARY Change in Fibromyalgia Survey Questionnaire |
10.8; 7.6 | — |
| SECONDARY Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Physical Functioning |
15.6; 16.3 | — |
| SECONDARY Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Anxiety |
7.8; 6 | — |
| SECONDARY Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Depression |
6.9; 5.5 | — |
| SECONDARY Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Fatigue |
10.9; 8.2 | — |
| SECONDARY Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Sleep Disturbance |
10.8; 11.2 | — |
| SECONDARY Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Social Participation |
13.5; 13.7 | — |
| SECONDARY Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Pain Interference |
10.5; 8.7 | — |
| SECONDARY Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Cognitive Function |
8; 8.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT05412121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.