Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2025-03-17
2025-05-16
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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 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.
Interventions
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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.
Self-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of Michigan
OTHER
Responsible Party
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Anna Kratz
Principal Investogator
Principal Investigators
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Anna Kratz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HUM00268311
Identifier Type: -
Identifier Source: org_study_id
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