Trial Outcomes & Findings for Acupressure in Rheumatoid Arthritis (NCT NCT05412121)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

up to day 42 (during acupressure)

Results posted on

2024-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	14
Overall Study Day 42 - End of Treatment	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	4
Overall Study Physician Decision	1
Overall Study Lost to Follow-up	5

Baseline Characteristics

Acupressure in Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acupressure n=14 Participants 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.
Age, Continuous	53 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acupressure n=14 Participants 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.
Feasibility of Self-performed Acupressure in Patients With Rheumatoid Arthritis Assessed by the Number of Sessions Completed	6 Participants

PRIMARY outcome

Timeframe: Day 42 (during acupressure)

Population: 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.

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.'

Outcome measures

Outcome measures
Measure	Acupressure n=6 Participants 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.
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 1	7 score on a scale Interval 3.0 to 10.0

PRIMARY outcome

Timeframe: Day 42 (during acupressure)

Population: 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.

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.'

Outcome measures

Outcome measures
Measure	Acupressure n=6 Participants 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.
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 2	4 score on a scale Interval 1.0 to 8.0

PRIMARY outcome

Timeframe: Day 42 (during acupressure)

Population: Only participants who completed the survey at the Day 42 session were analyzed.

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.

Outcome measures

Outcome measures
Measure	Acupressure n=6 Participants 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.
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 3	2 Participants

PRIMARY outcome

Timeframe: Day 42 (during acupressure)

Population: Only participants who completed the survey at the Day 42 session were analyzed.

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.

Outcome measures

Outcome measures
Measure	Acupressure n=6 Participants 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.
Acceptability of Self-performed Acupressure in Patients With RA Assessed by Acupressure Tolerability Scale at Day 42 - Question 4	1 Participants

SECONDARY outcome

Timeframe: Baseline to Day 42

Population: 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.

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.