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The goal of this pilot trial is to better understand if acupressure is feasible and tolerable to people with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupressure | Experimental | The self-acupressure intervention will be delivered using the modified MeTime Acupressure mobile application (App) in addition to in-person or virtual instruction via study staff. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupressure | Device | 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. There are 9 acupressure points, totaling 27 minutes of stimulation per day. Participants will perform daily acupressure for a total of six weeks. In addition all participants will complete a battery of validated questionnaires before, during and after completion of treatment intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed | 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. | up to day 42 (during acupressure) |
| Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 1 | 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.' | Day 42 (during acupressure) |
| Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 2 | 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.' | Day 42 (during acupressure) |
| Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 3 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fibromyalgia Survey Questionnaire | The fibromyalgia survey questionnaire comprises a measure of widespread body pain (0-19 points; one point per body location) and an assessment of comorbid symptoms (0-12 points including fatigue/depression/sleep/cognition) which are added together for a total possible score of 0-31 (0 being the lowest score, reflecting the least amount of pain and co-morbid symptoms; 31 being the highest score, reflecting the highest amount of pain and co-morbid symptoms captured on the scale). Scores are reported as a single composite score of the total number of points. A score of 13 or higher is needed for the Fibromyalgia diagnosis. This can arise from multiple combinations of the widespread pain and symptom severity scores. Results are an average of the participants' scores collected at baseline and at Day 42. |
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Inclusion Criteria:
- 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:
Adalimumab (Humira) Etanercept (Enbrel) Certolizumab pegol (Cimzia) Golimumab (Simponi) Infliximab (Remicade)
Tofacitinib (Xeljanz) Baracitinib (Olumiant) Upadacitinib (Rinvoq)
o Rituximab (Rituxan)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Murphy, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupressure | The self-acupressure intervention was delivered using the modified MeTime Acupressure mobile application (App) in addition to in-person or virtual instruction via study staff. Acupressure: The MeTime Acupressure app was loaded onto computer tablets or smart phones by the participants. Participants also received an AcuWand to be used in association with the acupressure app to help participants apply the correct amount of pressure to acupoints. There were 9 acupressure points, totaling 27 minutes of stimulation per day. Participants performed daily acupressure for a total of six weeks. In addition all participants completed a battery of validated questionnaires before, during, and after completion of treatment intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupressure | The self-acupressure intervention was delivered using the modified MeTime Acupressure mobile application (App) in addition to in-person or virtual instruction via study staff. Acupressure: The MeTime Acupressure app was loaded onto computer tablets or smart phones by the participants. Participants also received an AcuWand to be used in association with the acupressure app to help participants apply the correct amount of pressure to acupoints. There were 9 acupressure points, totaling 27 minutes of stimulation per day. Participants performed daily acupressure for a total of six weeks. In addition all participants completed a battery of validated questionnaires before, during, and after completion of treatment intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed | 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. | Posted | Count of Participants | Participants | up to day 42 (during acupressure) |
|
63 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupressure | The self-acupressure intervention was delivered using the modified MeTime Acupressure mobile application (App) in addition to in-person or virtual instruction via study staff. Acupressure: The MeTime Acupressure app was loaded onto computer tablets or smart phones by the participants. Participants also received an AcuWand to be used in association with the acupressure app to help participants apply the correct amount of pressure to acupoints. There were 9 acupressure points, totaling 27 minutes of stimulation per day. Participants performed daily acupressure for a total of six weeks. In addition all participants completed a battery of validated questionnaires before, during, and after completion of treatment intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Murphy | University of Michigan | 734-936-5566 | aemurph@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2023 | Feb 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019050 | Acupressure |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Day 42 (during acupressure) |
| Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 4 | 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. | Day 42 (during acupressure) |
| Baseline to Day 42 |
| Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Physical Functioning | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function and pain intensity. This physical function subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest/worst physical functioning) and 20 (reflecting highest/best physical functioning). | Baseline to Day 42 |
| Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Anxiety | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function, and pain intensity. This anxiety subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest anxiety) and 20 (reflecting highest anxiety). | Baseline to Day 42 |
| Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Depression | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function and pain intensity. This depression subscale consists of 3 questions, which can result in a raw score of between 3 (reflecting lowest depression) and 15 (reflecting highest depression). | Baseline to Day 42 |
| Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Fatigue | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function, and pain intensity. This fatigue subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest fatigue) and 20 (reflecting highest fatigue). | Baseline to Day 42 |
| Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Sleep Disturbance | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function, and pain intensity. This sleep subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lower sleep disturbance and therefore better sleep quality) and 20 (reflecting highest sleep disturbance and therefore worse sleep quality). | Baseline to Day 42 |
| Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Social Participation | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function, and pain intensity. This social participation subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest/worst ability to participate in social roles and activities) and 20 (reflecting highest/best ability to participate in social roles and activities). | Baseline to Day 42 |
| Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Pain Interference | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function, and pain intensity. This pain interference subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest pain interference) and 20 (reflecting highest pain interference). | Baseline to Day 42 |
| Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Cognitive Function | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function. This cognitive function subscale consists of 2 questions, which can result in a raw score of between 2 (reflecting lowest/worst cognitive function) and 10 (reflecting highest/best cognitive function). | Baseline to Day 42 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 1 | 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.' | Only participants who completed the survey at the Day 42 session were analyzed. Neither a p-value nor an estimation parameter were used due to the small participant sample size. | Posted | Mean | Full Range | score on a scale | Day 42 (during acupressure) |
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| Primary | Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 2 | 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.' | Only participants who completed the survey at the Day 42 session were analyzed. Neither a p-value nor an estimation parameter were used due to the small participant sample size. | Posted | Mean | Full Range | score on a scale | Day 42 (during acupressure) |
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| Primary | Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 3 | 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. | Only participants who completed the survey at the Day 42 session were analyzed. | Posted | Count of Participants | Participants | Day 42 (during acupressure) |
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| Primary | Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 4 | 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. | Only participants who completed the survey at the Day 42 session were analyzed. | Posted | Count of Participants | Participants | Day 42 (during acupressure) |
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| Secondary | Change in Fibromyalgia Survey Questionnaire | The fibromyalgia survey questionnaire comprises a measure of widespread body pain (0-19 points; one point per body location) and an assessment of comorbid symptoms (0-12 points including fatigue/depression/sleep/cognition) which are added together for a total possible score of 0-31 (0 being the lowest score, reflecting the least amount of pain and co-morbid symptoms; 31 being the highest score, reflecting the highest amount of pain and co-morbid symptoms captured on the scale). Scores are reported as a single composite score of the total number of points. A score of 13 or higher is needed for the Fibromyalgia diagnosis. This can arise from multiple combinations of the widespread pain and symptom severity scores. Results are an average of the participants' scores collected at baseline and at Day 42. | 14 participants completed the survey at baseline. Only 6 participants completed the survey at the Day 42 session. Neither a p-value nor an estimation parameter were used due to the small participant sample size. | Posted | Mean | Full Range | score on a scale | Baseline to Day 42 |
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| Secondary | Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Physical Functioning | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function and pain intensity. This physical function subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest/worst physical functioning) and 20 (reflecting highest/best physical functioning). | 14 participants completed the survey at baseline. Only 6 participants completed the survey at the Day 42 session. | Posted | Mean | Full Range | score on a scale | Baseline to Day 42 |
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| Secondary | Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Anxiety | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function, and pain intensity. This anxiety subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest anxiety) and 20 (reflecting highest anxiety). | 14 participants completed the survey at baseline. Only 6 participants completed the survey at the Day 42 session. | Posted | Mean | Full Range | score on a scale | Baseline to Day 42 |
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| Secondary | Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Depression | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function and pain intensity. This depression subscale consists of 3 questions, which can result in a raw score of between 3 (reflecting lowest depression) and 15 (reflecting highest depression). | 14 participants completed the survey at baseline. Only 6 participants completed the survey at the Day 42 session. | Posted | Mean | Full Range | score on a scale | Baseline to Day 42 |
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| Secondary | Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Fatigue | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function, and pain intensity. This fatigue subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest fatigue) and 20 (reflecting highest fatigue). | 14 participants completed the survey at baseline. Only 6 participants completed the survey at the Day 42 session. | Posted | Mean | Full Range | score on a scale | Baseline to Day 42 |
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| Secondary | Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Sleep Disturbance | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function, and pain intensity. This sleep subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lower sleep disturbance and therefore better sleep quality) and 20 (reflecting highest sleep disturbance and therefore worse sleep quality). | 14 participants completed the survey at baseline. Only 6 participants completed the survey at the Day 42 session. | Posted | Mean | Full Range | score on a scale | Baseline to Day 42 |
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| Secondary | Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Social Participation | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function, and pain intensity. This social participation subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest/worst ability to participate in social roles and activities) and 20 (reflecting highest/best ability to participate in social roles and activities). | 14 participants completed the survey at baseline. Only 6 participants completed the survey at the Day 42 session. | Posted | Mean | Full Range | score on a scale | Baseline to Day 42 |
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| Secondary | Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Pain Interference | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function, and pain intensity. This pain interference subscale consists of 4 questions, which can result in a raw score of between 4 (reflecting lowest pain interference) and 20 (reflecting highest pain interference). | 14 participants completed the survey at baseline. Only 6 participants completed the survey at the Day 42 session. | Posted | Mean | Full Range | score on a scale | Baseline to Day 42 |
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| Secondary | Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Cognitive Function | The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function. This cognitive function subscale consists of 2 questions, which can result in a raw score of between 2 (reflecting lowest/worst cognitive function) and 10 (reflecting highest/best cognitive function). | 14 participants completed the survey at baseline. Only 6 participants completed the survey at the Day 42 session. | Posted | Mean | Full Range | score on a scale | Baseline to Day 42 |
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| 0 |
| 14 |
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| 14 |
| 1 |
| 14 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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