Acupressure in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Feasibility and Acceptability of Acupressure in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05412121
• Other study ID #: HUM00206002
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot trial is to better understand if acupressure is feasible and tolerable to people with rheumatoid arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 20, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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:

• Methotrexate (Trexall, Rheumatrex)

• Hydroxychloroquine (Plaquenil)

• Sulfasalazine (Azulfadine)

• Leflunomide (Arava)

• Tocilizumab (Actemra)

• 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)

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• Acupressure
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to day 42 (during acupressure)
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.'	Day 42 (during acupressure)
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.'	Day 42 (during acupressure)
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.	Day 42 (during acupressure)
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.	Day 42 (during acupressure)
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.	Baseline to Day 42
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).	Baseline to Day 42
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).	Baseline to Day 42
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).	Baseline to Day 42
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).	Baseline to Day 42
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).	Baseline to Day 42
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).	Baseline to Day 42
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).	Baseline to Day 42
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).	Baseline to Day 42