Fatigue Symptom, Multiple Sclerosis, Pain
Conditions
Keywords
chronic pain, acupressure, digital health, fatigue, usability, feasibility
Brief summary
The Me Time MS Application was designed to enable self-administration of acupressure. Two forms of acupressure - either relaxing or stimulating protocols - are administered through the Me Time MS app. The goal of this study is to assess the usability of the Me Time MS app in a sample of 10 adults with multiple sclerosis (MS).
Interventions
BEHAVIORALSelf-guided smartphone application for relaxing acupressure
Relaxing Acupressure entails applying pressure with either a finger, pencil, or similar object to acupressure points. For the relaxing protocol, there is a total of 9 acupoints (1 unilateral and 4 bilateral). 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.
BEHAVIORALSelf-guided smartphone application for stimulating acupressure
There is a total of 10 acupoints (2 unilateral and 4 bilateral). 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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Perception of Me Time MS App Usability | Up to 2 weeks after the 6-week app usage period ended | Qualitative descriptions of positive, negative, and neutral aspects of usability of the Me Time MS app, gathered through one-on-one, open-ended interviews after 6 weeks of access to the app. Results reflect the total number of comments across all participants that were provided for each category. Participants could submit multiple types of comments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) Adapted for the MeTime MS App | Up to 2 weeks after the 6-week app usage period ended | SUS is a custom, 10-item survey to assess the participant's perception of the usability of the MeTime MS app. Possible total score ranges from 0 (lowest usability) to 40 (highest usability). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Relaxing Self-Acupressure Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks.
Self-guided smartphone application for relaxing acupressure: Relaxing Acupressure entails applying pressure with either a finger, pencil, or similar object to acupressure points. For the relaxing protocol, there is a total of 9 acupoints (1 unilateral and 4 bilateral). 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. | 5 |
| Stimulating Self-Acupressure Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks.
Self-guided smartphone application for relaxing acupressure: There is a total of 10 acupoints (2 unilateral and 4 bilateral). 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. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Relaxing Self-Acupressure | Stimulating Self-Acupressure | Total |
|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 7.65 | 54 years STANDARD_DEVIATION 9.67 | 51.00 years STANDARD_DEVIATION 8.81 |
| Education Level Associates/Technical Degree | 2 Participants | 1 Participants | 3 Participants |
| Education Level Bachelor's Degree | 1 Participants | 2 Participants | 3 Participants |
| Education Level High school graduate | 1 Participants | 0 Participants | 1 Participants |
| Education Level Master's Degree | 1 Participants | 1 Participants | 2 Participants |
| Education Level Some college, No Degree | 0 Participants | 1 Participants | 1 Participants |
| Employment Status Disabled | 3 Participants | 2 Participants | 5 Participants |
| Employment Status Working Full Time | 2 Participants | 2 Participants | 4 Participants |
| Employment Status Working Part time | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mobility aid Cane/Walker | 3 Participants | 1 Participants | 4 Participants |
| Mobility aid Manual Wheelchair | 0 Participants | 1 Participants | 1 Participants |
| Mobility aid Participant Did Not Respond | 0 Participants | 1 Participants | 1 Participants |
| Mobility aid Walk without assistance | 2 Participants | 2 Participants | 4 Participants |
| Multiple sclerosis (MS) Subtype Primary Progressive Multiple Sclerosis | 1 Participants | 1 Participants | 2 Participants |
| Multiple sclerosis (MS) Subtype Relapsing-Remitting Multiple Sclerosis | 4 Participants | 3 Participants | 7 Participants |
| Multiple sclerosis (MS) Subtype Secondary Progressive Multiple Sclerosis | 0 Participants | 1 Participants | 1 Participants |
| Patient-determined Disease Steps (PDDS) Bilateral Support | 0 Participants | 0 Participants | 0 Participants |
| Patient-determined Disease Steps (PDDS) Early cane | 2 Participants | 1 Participants | 3 Participants |
| Patient-determined Disease Steps (PDDS) Gait Disability | 0 Participants | 1 Participants | 1 Participants |
| Patient-determined Disease Steps (PDDS) Late Cane | 1 Participants | 1 Participants | 2 Participants |
| Patient-determined Disease Steps (PDDS) Mild Disability | 1 Participants | 1 Participants | 2 Participants |
| Patient-determined Disease Steps (PDDS) Moderate Disability | 0 Participants | 0 Participants | 0 Participants |
| Patient-determined Disease Steps (PDDS) Normal | 1 Participants | 0 Participants | 1 Participants |
| Patient-determined Disease Steps (PDDS) Wheelchair/Scooter | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment United States | 5 Participants | 5 Participants | 10 Participants |
| Sex/Gender, Customized Female | 3 Participants | 5 Participants | 8 Participants |
| Sex/Gender, Customized Male | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Prefer Not to Answer | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 4 / 5 | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Participant Perception of Me Time MS App Usability
Qualitative descriptions of positive, negative, and neutral aspects of usability of the Me Time MS app, gathered through one-on-one, open-ended interviews after 6 weeks of access to the app. Results reflect the total number of comments across all participants that were provided for each category. Participants could submit multiple types of comments.
Time frame: Up to 2 weeks after the 6-week app usage period ended
Population: 3 participants in the Stimulating arm did not attend an interview.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Relaxing Self-Acupressure | Participant Perception of Me Time MS App Usability | Positive | 37 Comments |
| Relaxing Self-Acupressure | Participant Perception of Me Time MS App Usability | Negative | 9 Comments |
| Relaxing Self-Acupressure | Participant Perception of Me Time MS App Usability | Neutral | 13 Comments |
| Stimulating Self-Acupressure | Participant Perception of Me Time MS App Usability | Positive | 11 Comments |
| Stimulating Self-Acupressure | Participant Perception of Me Time MS App Usability | Negative | 4 Comments |
| Stimulating Self-Acupressure | Participant Perception of Me Time MS App Usability | Neutral | 6 Comments |
Secondary
System Usability Scale (SUS) Adapted for the MeTime MS App
SUS is a custom, 10-item survey to assess the participant's perception of the usability of the MeTime MS app. Possible total score ranges from 0 (lowest usability) to 40 (highest usability).
Time frame: Up to 2 weeks after the 6-week app usage period ended
Population: 3 participants in the Stimulating Arm did not complete the SUS survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Relaxing Self-Acupressure | System Usability Scale (SUS) Adapted for the MeTime MS App | 35.8 score on a scale | Standard Deviation 2.28 |
| Stimulating Self-Acupressure | System Usability Scale (SUS) Adapted for the MeTime MS App | 29.5 score on a scale | Standard Deviation 6.36 |