Acupressure in Rheumatoid Arthritis

Not Applicable

Completed

Conditions: Rheumatoid Arthritis

Interventions: Device: Acupressure

Registration Number: NCT05412121

Lead Sponsor: University of Michigan

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 14

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupressure	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 3	Day 42 (during acupressure)	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.
Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed	up to day 42 (during acupressure)	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.
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 1	Day 42 (during acupressure)	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.'
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 2	Day 42 (during acupressure)	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.'
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 4	Day 42 (during acupressure)	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Depression	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 and pain intensity. This depression subscale consists of 3 questions, which can result in a raw score of between 3 (reflecting lowest depression) and 15 (reflecting highest depression).
Change in Fibromyalgia Survey Questionnaire	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) which are added together for a total possible score of 0-31 (0 being the lowest score, reflecting the least amount of pain and co-morbid symptoms; 31 being the highest score, reflecting the highest amount of pain and co-morbid symptoms captured on the scale). Scores are reported as a single composite score of the total number of points. A 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. Results are an average of the participants' scores collected at baseline and at Day 42.
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Physical Functioning	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 and pain intensity. This physical function subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest/worst physical functioning) and 20 (reflecting highest/best physical functioning).
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Anxiety	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, and pain intensity. This anxiety subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest anxiety) and 20 (reflecting highest anxiety).
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Fatigue	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, and pain intensity. This fatigue subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest fatigue) and 20 (reflecting highest fatigue).
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Social Participation	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, and pain intensity. This social participation subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest/worst ability to participate in social roles and activities) and 20 (reflecting highest/best ability to participate in social roles and activities).
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Sleep Disturbance	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, and pain intensity. This sleep subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lower sleep disturbance and therefore better sleep quality) and 20 (reflecting highest sleep disturbance and therefore worse sleep quality).
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Pain Interference	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, and pain intensity. This pain interference subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest pain interference) and 20 (reflecting highest pain interference).
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Cognitive Function	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. This cognitive function subscale consists of 2 questions, which can result in a raw score of between 2 (reflecting lowest/worst cognitive function) and 10 (reflecting highest/best cognitive function).