Rheumatoid ArthritisNCT05412121
Acupressure in Rheumatoid Arthritis
A study testing Acupressure in people with Rheumatoid Arthritis, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this pilot trial is to better understand if acupressure is feasible and tolerable to people with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Acupressure
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Methotrexate (Trexall, Rheumatrex)
- Hydroxychloroquine (Plaquenil)
- Sulfasalazine (Azulfadine)
- Leflunomide (Arava)
- Tocilizumab (Actemra)
Show all 13Show fewer
- Tumor necrosis factor inhibitor (TNFi), including:
- Adalimumab (Humira) Etanercept (Enbrel) Certolizumab pegol (Cimzia) Golimumab (Simponi) Infliximab (Remicade)
- Abatacept (Orencia)
- Tocilizumab (Actemra)
- Janus kinase inhibitor (JAKi), including:
- Tofacitinib (Xeljanz) Baracitinib (Olumiant) Upadacitinib (Rinvoq)
- o Rituximab (Rituxan)
Who cannot join
- 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 oral morphine equivalents)
- Taking blood thinners, including warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)
Show all 11Show fewer
- 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 principal investigator or study team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Acupressure in Patients With Rheumatoid Arthritis
The goal of this pilot trial is to better understand if acupressure is feasible and tolerable to people with rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Acupressure
- Keywords
- Acupressure, AcuWand, MeTime
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.'
Measured: 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.'
Measured: 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.
Measured: 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.
Measured: Day 42 (during acupressure)
Secondary outcomes (9)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start15 Sep 2022
- Primary completion14 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Murphy, University of Michigan
- Investigators
- Anne Murphy, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412121
- Sponsor's protocol ID
- HUM00206002
- Status last verified
- Apr 2024
- First submitted
- 6 Jun 2022
- Last updated
- 9 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Acupressure in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05412121
- Acronym / sponsor ID
- HUM00206002
- Conditions
- Rheumatoid Arthritis
- Keywords
- Acupressure, AcuWand, MeTime
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Posted 9 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot trial is to better understand if acupressure is feasible and tolerable to people with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Device: AcupressureThe 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Methotrexate (Trexall, Rheumatrex)
- Hydroxychloroquine (Plaquenil)
- Sulfasalazine (Azulfadine)
- Leflunomide (Arava)
Key exclusion criteria (11 listed)
- 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 oral morphine equivalents)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupressureThe 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. | Device | Acupressure |
Primary outcome
Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed
Time frame: up to day 42 (during acupressure)
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.
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 1
Time frame: Day 42 (during acupressure)
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.'
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 2
Time frame: Day 42 (during acupressure)
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.'
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 3
Time frame: Day 42 (during acupressure)
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.
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 4
Time frame: Day 42 (during acupressure)
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.
9 secondary outcomes
Change in Fibromyalgia Survey Questionnaire
Time frame: Baseline to Day 42
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Physical Functioning
Time frame: Baseline to Day 42
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Anxiety
Time frame: Baseline to Day 42
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Depression
Time frame: Baseline to Day 42
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Fatigue
Time frame: Baseline to Day 42
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Sleep Disturbance
Time frame: Baseline to Day 42
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Social Participation
Time frame: Baseline to Day 42
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Pain Interference
Time frame: Baseline to Day 42
Change in the Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS-29 +2) - Cognitive Function
Time frame: Baseline to Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Murphy, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Rheumatoid Arthritis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed (time frame: up to day 42 (during acupressure)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.