Feasibility and Acceptability of Acupressure in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 3
研究概览
简要总结
The goal of this pilot trial is to better understand if acupressure is feasible and tolerable to people with rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 3
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Depression(Baseline to Day 42)
- 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) - Fatigue(Baseline to Day 42)
- Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Social Participation(Baseline to Day 42)
- Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Sleep Disturbance(Baseline to Day 42)
- Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Pain Interference(Baseline to Day 42)
- Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Cognitive Function(Baseline to Day 42)
研究者
Anne Murphy
House Officer, Internal Medicine
University of Michigan