Feasibility and Acceptability of Acupressure in Patients With Rheumatoid Arthritis
Phase: NA
Conditions: Rheumatoid Arthritis
Sponsor: University of Michigan

The Feasibility and Acceptability of Acupressure in 
Patients with Rheumatoid Arthritis 
NCT05412121 
Date of IRB Approval: May 18, 2023 
 
 

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Research Design - Study Protocol: Feasibility and Acceptability of Acupressure in Patient with 
Rheumatoid Arthritis 
 
1.1 Objective  
The purpose of this pilot study is to assess the feasibility and acceptability of acupressure in 
patients with rheumatoid arthritis (RA). This study will allow us to better estimate the needed 
sample size and to focus on specific primary outcome measures for future studies. 
 
1.2 Specific Aim/Hypothesis 
(1) Aim 1: Determine the feasibility and acceptability of self-performed acupressure in patients 
with RA.  
(2) Aim 2: Assess the impact of acupressure of the pain, fatigue, and sleep of patients with RA.  
(3) Aim 3: Assess the impact of acupressure on disease activity in patients with RA. 
1.3 Background Information  
Acupuncture is a component of Traditional Chinese Medicine wherein thin needles are inserted 
at specific points on the body (acupoints) to treat disease. Research over the past three 
decades has shown that acupuncture is effective for the treatment of chronic pain (for recent 
meta-analysis see1). Acupressure is a related technique wherein pressure is applied via a finger 
or device to specific acupoints. Acupressure is highly scalable and can be taught to patients (for 
self-application) and supported by the use of technology. While less research has been 
performed on self-applied acupressure, emerging data indicates that self-acupressure is 
effective for chronic pain.2-7 In our own studies, we completed a randomized clinical trial in 288 
fatigued breast cancer survivors who self-administered acupressure (as proposed in this 
application) and found significant improvements in pain, fatigue, sleep, and depression.8, 9 We 
also recently completed a randomized controlled trial of our acupressure intervention in 67 
chronic low back pain patients randomized to either acupressure or usual care. In that pilot 
study, self-acupressure reduced low back pain more so than usual care (35% reduction, p<0.05) 
after 6 weeks of treatment.  
RA is the most common inflammatory arthritis with a prevalence of 0.5-1% in the United 
States.10,11,12 RA is a symmetric polyarthritis characterized by synovitis and systemic 
inflammation. RA associated with significant morbidity, chronic disability, pain, stiffness, sleep 
disturbance and increased rates of depression. 13  
Acupuncture is thought to help in RA. In a meta-analysis of 43 studies of complementary and 
alternative medicine in RA patients, acupuncture was able to improve quality of life in 42 
studies.14 Acupuncture has been recommended via professional agreement as a non-drug 

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intervention in RA.15 These data support the proposal of using self-acupressure as an 
intervention to treat the symptoms of RA. 
Acupressure has never been studied in RA. The purpose of this pilot study is to assess the 
feasibility and acceptability of acupressure in patients with RA.  
1.4 Methodology  
This will be an open feasibility study of 30 subjects conducted at the University of Michigan 
1.4.1 Participants. We will enroll 30 adults (age 25-75) with a RA diagnosis from the 
Rheumatology Clinics at UM primary and satellite sites. Detailed inclusion and exclusion criteria 
and rationale for exclusions are detailed below. 
Inclusion: 
• Patient is being treated for 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: 
o Methotrexate (Trexall, Rheumatrex) 
o Hydroxychloroquine (Plaquenil) 
o Sulfasalazine (Azulfadine) 
o Leflunomide (Arava) 
o Tumor necrosis factor inhibitor (TNFi), including: 
 Adalimumab (Humira) 
 Etanercept (Enbrel) 
 Certolizumab pegol (Cimzia) 
 Golimumab (Simponi) 
 Infliximab (Remicade) 
o Abatacept (Orencia) 
o Tocilizumab (Actemra) 
o Janus kinase inhibitor (JAKi), including: 
 Tofacitinib (Xeljanz) 
 Baracitinib (Olumiant) 
 Upadacitinib (Rinvoq) 
o Rituximab (Rituxan) 
• Ages 25 – 75 
 
Exclusion: 
• 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 OME per day), 

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• 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 PI or study team 
 
1.4.2 Assessments. Pre-screening and recruitment will occur virtually or in-person in clinic. 
Trained study staff may perform consent in-person at the time of recruitment if feasible and 
desired by the patient. The study visit will occur at the Chronic Pain and Fatigue Research 
Center, University of Michigan at Domino Farms. At the initial visit, Day 0, the informed consent 
process conducted by trained study staff, if not already completed. This will be followed by 
questionnaire completion using Qualtrics electronic data capture system, and orientation and 
training on the acupressure device and ambulatory mobile support technology. Table 1 
indicates the timeline of the study and when questionnaires will be administered throughout 
the study. Day 1 treatment will occur via Zoom with the participant and a study coordinator. 
The participant will perform the treatment with the coordinator observing the technique and 
available to answer any questions the participant may have. 
Participants will be provided with a pre-addressed, pre-paid box to return the AcuWand or may 
return it in person to the study team at Domino’s Farms. 
 
Table 1: Timeline of Study 
 
Day 0 
Day 1 
Day 7 
Day 21 
Day 42 
Day 63 
 
Initial 
visit 
 
 
 
 
 
Screening (if not done) 
X 
 
 
 
 
 
Consent (if not done) 
X 
 
 
 
 
 
Treatment 
 
X-Zoom 
X 
X 
X 
 
Questionnaires: 
 
 
 
 
 
 
  Past Med/Surg Hx 
X 
 
 
 
 
 
  PROMIS 29+2 
X 
 
 
X 
X 
X 
  FMS 
X 
 
 
X 
X 
X 
  HAQ 
X 
 
 
X 
X 
X 
  RA disease activity 
X 
 
 
X 
X 
X 
  Desire for relief 
X 
 
 
 
 
 
  Expected relief 
X 
 
 
 
 
 
  Credibility 
 
 
 
 
X 
 
  Tolerability 
 
 
 
X 
X 
 
  Acupr. sensation 
 
 
 
X 
X 
 
  PGIC 
 
 
 
 
X 
 
Phone call 
 
 
X 
 
 
 
FMS = Fibromyalgia Survey Questionnaire. HAQ = Health Assessment Questionnaire. Acupr. Sensation = Acupressure sensation. 
PGIC = Patient Global Impression of Change. 

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Clinical data. Participants will undergo an assessment of past medical history and pregnancy 
status. Medications (especially analgesics including opioids), diagnoses, pain interventions, and 
any relevant labs already collected for clinical purposes will be confirmed via EMR review. 
Questionnaires. All participants will complete a battery of validated questionnaires before, 
during and after completion of treatment intervention. Questionnaires will measure pain, sleep 
disturbance, fatigue, and depression given the increased rates of these outcomes in patients 
with RA. Questionnaires will also focus on acupressure expectations, tolerability, and 
acceptability. Questionnaires will be applied pre-treatment, at 3 and 6 weeks into treatment, 
and 3 weeks post-treatment intervention (see Table 1). Surveys will be sent via email, and if 
needed, reminder phone calls will also be utilized. 
1.4.3 Study Procedures:  
1.4.3a Acupressure Intervention Procedures 
The self-acupressure intervention will be delivered using the modified 
MeTime Acupressure mobile app in addition to in-person or virtual 
instruction via study staff. The MeTime Acupressure app was developed 
in association with patient focus groups (six focus groups each of eight 
to ten women) and the University of Michigan 3D Media Laboratory 
(screen shot examples in Figure 2). 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 (See Figure 1 ).  
There are 5 acupoints with 4 of the acupoints performed 
on both the left and 
right sides of the 
body (total of 9 
points to stimulate; 
see Figure 3. The 
relaxing acupoints are:  
 Point 1: Yin tang (Unilaterally) 
 Point 2: Anmian (EX17) (Bilaterally) 
 Point 3: Heart 7 (HT7) (Bilaterally) 
 Point 4: Spleen 6 (SP6) (Bilaterally) 
 Point 5: Liver 3 (LV3) (Bilaterally) 
Figure 2 Sample MeTime Acupressure 
App 
Figure 1 AcuWand Device 
Figure 3 Relaxing Acupressure 

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Participants will be introduced to the MeTime App and AcuWand device at their initial clinic 
visit. A research team member will provide the patient with instructions and guide the patient 
through using the app, the AcuWand and performing Self-Acupressure. Study participants will 
be told to perform acupressure once per day and to stimulate each point a circular motion for 
three minutes. There are 9 acupressure points, totaling 27 minutes of stimulation per day. 
Participants will perform daily acupressure for a total of six weeks. 
1.4.3b Participant Adherence 
Participants will be asked to log time spent using the AcuWand on a daily basis and record any 
reasons for missed sessions. The Acuwand device also records the time a participant spends 
using the device.  
 
1.4.3c Standardizing Assessment and Intervention 
Fidelity of the acupressure intervention in study staff, who are teaching participants 
acupressure, i.e., acupressure educators will be assessed by study investigator Rick Harris. 
Educators will be trained using the Acupressure Therapist Treatment Manual (see supporting 
documents).  
The primary outcome will be the feasibility and acceptability of self-performed acupressure in 
patients with RA. This will be assessed by the number of sessions completed and the 
acupressure acceptability questionnaire. 
The secondary outcome will be the impact of acupressure on pain. This will be assessed with 
PROMIS-29+2 questionnaire and the Fibromyalgia Survey Questionnaire. 
Exploratory outcomes in this study will include the impact of acupressure on fatigue, sleep, 
mood, and disease activity in patients with RA. These will be assessed by questionnaires. 
1.4.3d Acupressure Benefits 
Emerging data indicates that self-acupressure is effective for chronic pain.2-7 In our own studies, 
we completed a randomized clinical trial in 288 fatigued breast cancer survivors who self-
administered acupressure (as proposed in this application) and found significant improvements 
in pain, fatigue, sleep, and depression.8, 9 We also recently completed a randomized controlled 
trial of our acupressure intervention in 67 chronic low back pain patients randomized to either 
acupressure or usual care. In that pilot study, self-acupressure reduced low back pain more so 
than usual care (35% reduction, p<0.05) after treatment. We theorize that patients with RA 
may see benefits in pain, sleep, fatigue, and depression. 
1.4.3e Acupressure Risks 

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Potential Risk – Treatment Interaction – Acupressure. Self-acupressure is a safe intervention. 
From our previous 3 clinical trials over the past 10 years using this acupressure point formula, 
we have observed no serious adverse events associated with the study intervention. Our most 
recent and largest trial of self-acupressure in fatigued cancer survivors (N=288), had 6 adverse 
events related to acupressure, and all were non-serious cases of mild bruising at acupressure 
sites. There are no known long-term risks associated with self-acupressure. To minimize the 
chances of bruising, participants will be trained by the acupressure instructor in how to apply 
the correct amount of pressure with the AcuWand. Specific attention will be paid to not apply 
too much pressure. The AcuWand has a built in “buzzer” to notify the study participant when 
the correct amount of pressure is reached, which will minimize chances of bruising. The 
participant is free to withdraw from the intervention at any point if the self-acupressure 
intervention becomes uncomfortable. 
 
 
1.4.3f Management of expected adverse events 
Expected Adverse Event  
Criteria for 
Management 
Intervention Modification, if any 
Acupressure 
Mild bruising at 
acupressure sites 
Participant 
verbalizes bruising. 
The participant is free to withdraw from 
the intervention if the self-acupressure 
intervention becomes uncomfortable.  
1.5 Statistical Design  
Due to the pilot and feasibility nature of this study, we will primarily be using descriptive 
statistics. We will obtain pre-, during and post-treatment measures of disease activity and 
symptoms (pain, sleep disturbance, fatigue, and mood). These measures will be analyzed with t-
test or appropriate non-parametric test if data not appropriate. This is an open study.  
Aim 1: We will compare number of acupressure treatments performed to the number of total 
number of sessions required. We would consider successful feasibility to be over 80% of sessions 
completed. 
Aim 2: We will compare scores for pain, fatigue, and sleep on pre-treatment and post-treatment 
surveys with paired t-test to assess for significance. 
Aim 3: We will explore pre-treatment and post-treatment RA disease activity scores with paired t-
test to assess for significance. 
This is a pilot study and we do not expect that we will achieve statistical significance. With the 
sample size of 30 we would only be able to detect a difference between pre and post scores 
would be approximately 0.5 standard deviation. 
 

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