Usability of the MeTime MS Acupressure Mobile Application in Adults With MS
Phase: NA
Conditions: Multiple Sclerosis, Pain, Fatigue Symptom
Sponsor: University of Michigan

 
Usability of the MeTime MS Acupressure mobile 
application in adults with MS 
 
NCT07123272 
 
Date of IRB Approval: August 22, 2025 
 

STUDY PROTOCOL 
 
Usability of the MeTime MS Acupressure mobile application in adults with MS  
 
HUM00268311 
 
Principal Investigator: Anna Kratz, PhD 
 
 

BACKGROUND AND SPECIFIC AIM 
 
Background: Multiple sclerosis (MS) is an autoimmune disease of the central nervous system that 
affects approximately one million people in the United States and is the leading cause of non-
traumatic disability in young adults1-4. 
 
Fatigue is the most common symptom experienced by patients with multiple sclerosis 
(MS)5-7. The majority of persons with MS describe fatigue as their most disabling symptom, 
surpassing pain and even physical impairment. Fatigue impacts activities of daily living, social 
interactions, and quality of life, and has profound socioeconomic consequences, including loss of 
occupation6, 8-13. Even patients who outwardly appear unaffected by MS may experience severe 
fatigue that causes signiﬁcant functional impairment. Fatigue also remains one of the most difficult 
symptoms to manage, and a critical need exists to ﬁnd effective alternatives for managing fatigue in 
MS. 
 
Chronic pain is one of the most common and disabling symptoms in MS14-25. Unfortunately, 
current pain treatments do not provide sufficient or durable pain relief26, 27. Given the lack of 
effectiveness of conventional treatments for chronic pain, there is a dire need for effective 
alternatives.  
 
Acupuncture is a component of Traditional Chinese Medicine (TCM) where thin needles are 
inserted at speciﬁc points on the body (acupoints) to treat disease and alleviate symptoms. 
Research over the past three decades has shown that acupuncture is effective for the treatment of 
chronic pain28. Acupressure is a related TCM technique wherein pressure is applied with a ﬁnger or 
device to speciﬁc acupoints. Acupressure is highly scalable and can be taught to patients for self-
administration. Research on self-administered acupressure is in its infancy, though promising initial 
data indicates that self-acupressure is effective for chronic pain29, 30 and fatigue31, with one study 
suggesting that self-acupressure is effective in reducing fatigue in MS32. Research has found 
signiﬁcant improvements in pain, fatigue, sleep, and depression in breast cancer survivors33, 34 and 
improvements in pain intensity in chronic low back pain with self-acupressure35. Although there is 
evidence that acupuncture is effective at alleviating fatigue and pain in MS36, well-designed studies 
of self-acupressure for fatigue and pain in MS are needed to better understand the use of this 
therapy as complementary and integrative treatment for symptom management.  
 
Dr. Kratz adapted the existing MeTime mobile application for self-administered acupressure 
developed by Dr. Harris and Dr. Zick. The MeTime Acupressure app was originally developed in 
association with patient focus groups consisting of cancer survivors and the University of Michigan 
3D Media Laboratory. The adapted app, MeTime MS, has been tailored to be more relevant to the 
MS population, including an updated MS-speciﬁc introduction video. Before conducting a trial of 
self-acupressure for pain and fatigue in adults with MS, we aim to ﬁrst conduct a usability study of 
the adapted MeTime MS app in a small sample of adults with MS. 
Speciﬁc Aim: Assess the usability of the MeTime MS mobile application in adults with MS. 
 
METHODS 
Study Sample : We will enroll 10 adults with clinically signiﬁcant pain and fatigue and MS to use 
the MeTime MS app for 6 weeks and then participate in a focus group or one-one interview to 

assess their experience with using the app. Participants in the study must be diagnosed as having 
MS by a physician; this diagnosis status will be conﬁrmed through medical record review. 
Inclusion and exclusion criteria : 
Inclusion Criteria 
- 
MS diagnosis (all MS subtypes included) 
- 
Age 18 years or older 
- 
Average Fatigue Severity Scale (FSS) score ≥ 4 at screening coupled with the opinion of the 
volunteer that the fatigue has interfered with their daily activities for ≥ 3 months 
- 
Presence of chronic pain deﬁned as moderate to severe pain for ≥ 3-month duration that is 
≥ 4 on average using a 0-10 numerical rating scale 
- 
Home access to internet via Wi-Fi or cellular data 
- 
Active email account 
Exclusion Criteria 
- 
Not ﬂuent in English 
- 
Pregnancy or breast feeding, or anticipate pregnancy in next 6 months 
- 
Inability to use smartphone/tablet and/or MeTime MS mobile app 
- 
Anything at the discretion of the PI or study team that would preclude participation in the 
study 
Participant Recruitment: Participants will be recruited through existing participant registries, 
including the Kratz Lab registry (HUM00074021), through the University of Michigan Health System 
clinic-based referrals, in-person recruitment, electronic medical record reviews, through local 
support groups and informational groups and national and regional chapters of organizations, such 
as the National Multiple Sclerosis Society. Flyers may be disseminated in community settings and 
will be advertised on the www.UMHealthResearh.org website.  
 
Study procedures: After obtaining informed consent, participants will be assigned to use one of 
two versions of the MeTime MS app (N=5 each in the relaxation and stimulating protocols) for 6 
weeks. Participants will be provided with their version-speciﬁc access code and may use their own 
smartphones/tablets or receive a loaner device from the study team. Participants will be given a 
large pencil with eraser or similar tool for stimulating acupressure points; participants may also 
elect to simply use their ﬁngers/thumb to stimulate acupressure points.  
Baseline visits will be scheduled for after the participant receives the study equipment.  
The baseline visit will occur online via Zoom (or similar secure Michigan Medicine supported video 
conferencing system), with the following assessments and procedures completed: 
1) Demographic Information (See table 1) 
2) Pain and fatigue medication review (See table 1) 
3) Brief online questionnaire via REDCap to characterize the sample (See table 1) 
4) Orientation and training about acupressure intervention: 
a. Orientation of MeTime-MS mobile application; 
b. Demonstration of the location of all acupoints; 

c. Demonstration of the appropriate amount of pressure to apply to the acupoints and 
the correct stimulating motion. 
 
Participants will be instructed to begin use of the app the day after the baseline visit. 
The study team will contact participants weekly to assess for AEs and remain available for 
participant questions, concerns, and/or issues. 
At the end of the 6-week period, participants will complete a usability measure (adapted System 
Usability Scale) and participate in a focus group or one-on-one interview. In the focus 
group/interview, participants will be asked about their experience using the MeTime MS app (e.g. 
ease of use, relevance to MS, etc.)   
Participant compensation: Participants will be compensated $25 for the baseline visit and $75 for 
the focus group/interview. 
 
Primary outcome: The focus groups/interviews will be used to gather MeTime MS app usability 
data. If the qualitative information collected indicates the need for substantial change to the app, 
then a second round of focus groups/interviews will be conducted for the original end users to 
provide feedback on the updated apps. User feedback will inform improvement to the app and the 
design of a future clinical trial. 
Secondary outcome: The System Usability Scale (SUS)40 adapted for the MeTime MS app will be 
used to compliment the primary qualitative data on participant perceptions of the app usability.  
The SUS has 10 items; the total score ranges from 0-40, with higher scores indicating better 
usability. 
Quantitative analyses, including means, standard deviations, and percentages of the 
demographics and survey data will be conducted to describe the study sample.  
 
Table 1: Study Measures 
Domain 
Measure 
Sample Descriptive Measures 
Demographics 
Age, race, ethnicity, sex, gender, education level, etc. 
Disability Level 
Patient Determined Disease Steps (PDDS)37 
Fatigue 
PROMIS Fatigue Short Form 7a38 
Pain 
PROMIS Pain Intensity 3a39 
Medications 
Medications for pain and/or fatigue 
Secondary Outcome Measure 
Usability 
System Usability Scale (SUS)40 adapted for the MeTime MS app 
 
Data storage: This study will use REDCap, a secure, password protected, and HIPAA compliant 
web-based data platform hosted by the Michigan Institute for Clinical and Health Research 
(MICHR) at the UM for data capture and storage. This protected database will be accessed and 
maintained by study personnel only. This system features both a local and remote web-based 
interface, secure data transfer, and an Oracle database. Data security, patient privacy, and HIPAA 

requirements are a premium consideration for clinical trials research using REDCap. A complete 
time-stamped audit of all REDCap activity (including which and when study personnel access data) 
is maintained, adding to the security and ﬁdelity of the data. Study personnel can enter data into 
the database through administrative access to add to the self-report data provided by participants. 
For self-report data collection, participants will access individualized study URLs to securely enter 
data on an internet-connected device of their choosing (for home-based assessments). The study 
URLs and REDCap surveys are separate from the acupressure app.  
 
ADVERSE EVENT ASSESSMENTS 
Adverse events reported by participants that are 1) NOT related to the normal course or chronic 
symptoms of MS (such as relapses, MRI progression, somatic pain, weakness, numbness, visual 
disturbances, bladder/bowel symptoms), and 2) NOT events that are expected to occur in the 
course of daily life or use of disease modifying therapy (injuries, infections, disease modifying 
therapy infusion reactions, disease modifying therapy injection site reactions, disease modifying 
therapy-induced lymphopenia.  
SAE events will be collected regardless of relatedness to MS or disease modifying therapy use. 
 
AE/SAE Reporting: 
Multiple sclerosis is a disease with many disease-related symptoms and complications, and there 
are many common mild side effects associated with disease modifying therapy use. Due to the 
patient population and the nature of the disease, as well as the lack of experimental interventions 
in this study (only standard of care procedures and treatments will be used) we would like to 
implement the following AE/SAE collection/reporting guidelines:  
SAE events that meet all 3 of the following criteria will be collected and submitted to the IRB within 
14 days of notiﬁcation (or 7 days of notiﬁcation if event is fatal or life-threatening): 
- 
Serious; 
- 
Related (possibly, probably, or deﬁnitely); and  
- 
Unexpected 
SAEs that are unrelated, regardless of expectedness, will not be reported to the IRB.  
In addition, the following AEs will be collected and submitted to the IRB: 
- 
Any related and unexpected AE that results in a change to research or participant’s 
treatments plan. 
All other AEs documented during the study will be reported with scheduled continuation review. 
SAE Deﬁnition: 
An adverse event (AE) is any condition which appears or worsens after a participant is enrolled in an 
investigational study. An AE does not necessarily have a causal relationship with the study agent.  

A serious adverse event (SAE) is an adverse experience to acupressure treatment occurring at any 
timepoint that results in any of the following outcomes: 
a) Death 
b) A life-threatening adverse treatment experience 
c) Inpatient hospitalization or prolongation of existing hospitalization 
d) A persistent or signiﬁcant disability and/or incapacity 
e) A congenital anomaly or birth defect 
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered a serious adverse treatment experience when, based upon appropriate medical 
judgement, they may jeopardize the patient or subject and may require medical or surgical 
intervention to prevent one of the outcomes listed in this deﬁnition. A serious adverse experience 
includes any experience that is fatal or immediately life-threatening, results in a persistent or 
signiﬁcant disability/incapacity, requires or prolongs in-patient hospitalization, or is a congenital 
anomaly, cancer, or overdose.  
Other important medical events that may not result in death, not be life-threatening, or not require 
hospitalization may be considered a serious adverse experience when, based upon appropriate 
medical judgement, the event may jeopardize the subject/patient and may require medical or 
surgical intervention to prevent one of the outcomes listed previously.  
AE/SAE Relatedness: 
Relatedness of an adverse event may be measured by the following deﬁnitions: 
a) Deﬁnitely related: clearly associated with study treatment 
b) Probably related: likely associated with study treatment 
c) Possibly related: may be associated with study treatment 
d) Unlikely to be related, or 
e) Deﬁnitely not related to the study treatment 
For reporting purposes, an AE should be regarded as deﬁnitely or probably related to the regimen if 
the investigator believes that at least one of following criteria are met: 
a) There is a clinically plausible time sequence between onset of the AE and the 
administration of the study treatment.  
b) There is a biologically plausible mechanism for the study treatment causing or contributing 
to the AE.  
c) The AE cannot be attributed solely to concurrent/underlying illness, other drugs, or 
procedures. 
d) A potential alternative does not exist.  
AE/SAE Expectedness: 
Expected adverse events are those adverse events that are listed in the protocol or in the study 
informed consent document.  
Unexpected adverse events are those that: 

a) Are not described in the clinical protocol as far as the study treatment is concerned 
b) Are not anticipated in the study informed consent. This includes adverse events for which 
the speciﬁcity or severity is not consistent with the description in the informed consent.  
Unanticipated problem: Per FDA Procedural Guidance for Clinical Investigators, Sponsors, and 
IRBs (January 2009), a serious problem that has implications for the conduct of the study (requiring 
a signiﬁcant and usually safety-related, change in the protocol such as revising inclusion/exclusion 
criteria or including a new monitoring requirement, informed consent or investigator’s brochure).  
Unanticipated problem Reporting: Per 21 CFR 312.66, 312.53 (c)(1)(vii), and 56.108(b)(1), should an 
unanticipated problem occur during the investigation, the investigator will promptly report all 
unanticipated problems involving risks to human subjects or others to IRBMED and FDA. 
AE/SAE Severity: 
The severity of an adverse event may be measured using the following deﬁnitions: 
Mild: Noticeable to the subject, but does not interfere with subject’s expected daily activities, and 
usually does not require additional therapy or intervention, treatment reduction, or discontinuation 
of the study.  
Moderate: Interferes with the subject’s expected daily activities, may require some additional 
therapy or intervention but does not require discontinuation of the study. 
Severe: Extremely limits the subject’s daily activities and may require discontinuation of study 
therapy, and/or additional treatment or intervention to resolve. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
APPENDICES 
Appendix A: Acupressure procedures in MeTime MS app 
Participants will be randomized to the relaxation acupressure treatment, stimulating acupressure 
treatment, or sham acupressure treatment. Acupoints will be stimulated using the thumb, ﬁnger, or 
other tool (such as a pencil eraser; see Figure 1). Each acupoint will be stimulated for 3 continuous 
minutes, and in the order provided, starting with the head down to the feet. Participants will 
perform daily acupressure for a total of six weeks. 
 
Figure 1. Large pencil tip eraser for stimulating acupressure points. 
 
The relaxation and stimulating self-acupressure versions of the MeTime MS app will be used (see 
Figure 2), in addition to the virtual instruction by trained study staff at the baseline visit. Participants 
will be given the option to (A) download the assigned MeTime MS application onto their personal 
tablet or smartphone, or (B) use a study-provided device with the assigned MeTime MS application 
pre-downloaded. Within the MeTime MS app, participants will only have access to their assigned 
protocol (relaxing or stimulating). Each participant will be provided with a unique identiﬁer that is 
speciﬁc to the assigned protocol: the relaxation group identiﬁer is “blue”; the stimulating group 
identiﬁer is “yellow”. 

 
Figure 2. Screenshots from the MeTime MS Acupressure App. 
Relaxation Acupressure33-35 
There is a total of 9 acupoints (1 unilateral and 4 bilateral; see Figure 3). Each point will be 
stimulated for 3 minutes, yielding a total treatment time of 27 minutes each day. The acupoints are: 
1. Yin Tang (Unilaterally): Located on the forehead, between the eyebrows. 
2. Anmian (Right and Left/bilaterally): Located on the posterior aspect of the neck, in a slight 
depression along the bone directly behind the ear. 
3. Heart 7 (HT7) (Right and Left/bilaterally): Located on the palmer surface of the hands on the 
wrist crease; in line with the pinky. 
4. Spleen 6 (SP6) (Right and Left/bilaterally): Located on the inside of the lower leg, 
approximately 4 ﬁngers width above the bone of the ankle. 
5. Liver 3 (LIV3) (Right and Left/bilaterally): This point is located on the foot, near the big and 
second toes. 

 
Figure 3. Relaxation Acupressure Points 
 
Stimulating Acupressure33-35 
There is a total of 10 acupoints (2 unilateral and 4 bilateral; see Figure 4). Each point is stimulated 
for 3 minutes, yielding a total treatment time of 30 minutes each day. The acupoints are:  
1. Du 20 (Unilaterally): Located at the top of the head. 
2. Large Intestine 4 (LI4) (Right and Left/bilaterally): Located on the back of the hand, between 
your thumb and index ﬁnger. 
3. Conception Vessel 6 (CV6) (Unilaterally): Located two ﬁnger widths below the navel on the 
centerline. 
4. Stomach 36 (ST36) (Right and Left/bilaterally): Located on the lower leg below the knee on 
the outside of the leg. 
5. Spleen 6 (SP6) (Right and Left/bilaterally): Located on the inside of the lower leg, 
approximately 4 ﬁngers width above the bone of the ankle. 
6. Kidney 3 (K3) (Right and Left/bilaterally): Located on the inside of the ankle. 

 
Figure 4. Stimulating Acupressure Points 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
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