Trial Outcomes & Findings for Acupressure for Fatigue in Systemic Lupus Erythematosus (NCT NCT03200548)
NCT ID: NCT03200548
Last Updated: 2023-05-12
Results Overview
Fatigue severity and interference will be determined according the Brief Fatigue Inventory questionnaire. The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with the total score being the sum of a participant's individual questions scores at a timepoint and will range from 0 to 90. Lower scores are considered good, better, or healthy, and increasingly higher scores indicate greater fatigue.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
Four weeks post-treatment
Results posted on
2023-05-12
Participant Flow
One participant who was consented but did not actually begin the intervention.
Participant milestones
| Measure |
Relaxing Acupressure Plus Usual Care
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily.The "True Acupressure" points were chosen based on a TCM theory for treating insomnia.
Relaxing acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Stimulating Acupressure Plus Usual Care
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. Acupoints were chosen by consensus of 4 acupressure practitioners and based on a previous study design in students with sleep disturbances as well as TCM theory for treating insomnia and fatigue.
Stimulating acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Sham Acupressure Plus Usual Care
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. None of these points are on meridians nor are they on actual points. They were chosen to be in the same general body quadrant as the true points.
Sham acupressure plus usual care: Positive control group. Chosen pressure points are not known to be effective.
|
Usual Care
Participants will be asked to continue following their healthcare providers' instruction for chronic SLE management. We anticipate that most women will be treated per the American College of Rheumatology clinical guidelines. Participants will be asked to continue any current treatment and not to start or stop treatments including acupuncture/acupressure over the course of the study. All treatments for pain will be recorded.
Usual care: Negative control group. Participants are asked to carry on with their usual management practices and habits.
|
|---|---|---|---|---|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
7
|
6
|
|
Overall Study
STARTED
|
11
|
14
|
14
|
13
|
|
Overall Study
COMPLETED
|
6
|
3
|
7
|
7
|
Reasons for withdrawal
| Measure |
Relaxing Acupressure Plus Usual Care
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily.The "True Acupressure" points were chosen based on a TCM theory for treating insomnia.
Relaxing acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Stimulating Acupressure Plus Usual Care
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. Acupoints were chosen by consensus of 4 acupressure practitioners and based on a previous study design in students with sleep disturbances as well as TCM theory for treating insomnia and fatigue.
Stimulating acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Sham Acupressure Plus Usual Care
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. None of these points are on meridians nor are they on actual points. They were chosen to be in the same general body quadrant as the true points.
Sham acupressure plus usual care: Positive control group. Chosen pressure points are not known to be effective.
|
Usual Care
Participants will be asked to continue following their healthcare providers' instruction for chronic SLE management. We anticipate that most women will be treated per the American College of Rheumatology clinical guidelines. Participants will be asked to continue any current treatment and not to start or stop treatments including acupuncture/acupressure over the course of the study. All treatments for pain will be recorded.
Usual care: Negative control group. Participants are asked to carry on with their usual management practices and habits.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
11
|
7
|
6
|
Baseline Characteristics
Acupressure for Fatigue in Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
Relaxing Acupressure Plus Usual Care
n=11 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily.The "True Acupressure" points were chosen based on a TCM theory for treating insomnia.
Relaxing acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Stimulating Acupressure Plus Usual Care
n=14 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. Acupoints were chosen by consensus of 4 acupressure practitioners and based on a previous study design in students with sleep disturbances as well as TCM theory for treating insomnia and fatigue.
Stimulating acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Sham Acupressure Plus Usual Care
n=14 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. None of these points are on meridians nor are they on actual points. They were chosen to be in the same general body quadrant as the true points.
Sham acupressure plus usual care: Positive control group. Chosen pressure points are not known to be effective.
|
Usual Care
n=13 Participants
Participants will be asked to continue following their healthcare providers' instruction for chronic SLE management. We anticipate that most women will be treated per the American College of Rheumatology clinical guidelines. Participants will be asked to continue any current treatment and not to start or stop treatments including acupuncture/acupressure over the course of the study. All treatments for pain will be recorded.
Usual care: Negative control group. Participants are asked to carry on with their usual management practices and habits.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.4 years
n=5 Participants
|
47.3 years
n=7 Participants
|
53.3 years
n=5 Participants
|
46.5 years
n=4 Participants
|
49.1 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown & Refused
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Lupus flare severity categorization
No
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Lupus flare severity categorization
Mild
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Lupus flare severity categorization
Moderate
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Lupus flare severity categorization
Severe
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Four weeks post-treatmentPopulation: This is an intent to treat analysis.
Fatigue severity and interference will be determined according the Brief Fatigue Inventory questionnaire. The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with the total score being the sum of a participant's individual questions scores at a timepoint and will range from 0 to 90. Lower scores are considered good, better, or healthy, and increasingly higher scores indicate greater fatigue.
Outcome measures
| Measure |
Relaxing Acupressure Plus Usual Care
n=11 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily.The "True Acupressure" points were chosen based on a TCM theory for treating insomnia.
Relaxing acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Stimulating Acupressure Plus Usual Care
n=14 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. Acupoints were chosen by consensus of 4 acupressure practitioners and based on a previous study design in students with sleep disturbances as well as TCM theory for treating insomnia and fatigue.
Stimulating acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Sham Acupressure Plus Usual Care
n=14 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. None of these points are on meridians nor are they on actual points. They were chosen to be in the same general body quadrant as the true points.
Sham acupressure plus usual care: Positive control group. Chosen pressure points are not known to be effective.
|
Usual Care
n=13 Participants
Participants will be asked to continue following their healthcare providers' instruction for chronic SLE management. We anticipate that most women will be treated per the American College of Rheumatology clinical guidelines. Participants will be asked to continue any current treatment and not to start or stop treatments including acupuncture/acupressure over the course of the study. All treatments for pain will be recorded.
Usual care: Negative control group. Participants are asked to carry on with their usual management practices and habits.
|
|---|---|---|---|---|
|
Fatigue Severity and Interference
|
3.8 score on a scale
Interval 0.1 to 6.9
|
4.3 score on a scale
Interval 3.4 to 5.0
|
3.7 score on a scale
Interval 1.4 to 6.8
|
4.6 score on a scale
Interval 2.0 to 7.9
|
SECONDARY outcome
Timeframe: Four weeks post-treatmentQuality of Life will be determined by the Rand SF-36. It is a reliable and valid self-report questionnaire consisting of 36 items aggregated to score 8 subscales related to physical and mental health. Subscales include Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Function, Role Emotional and Mental Health. Each subscale is calibrated to a scale from 0 to 100 where 0 represents worst outcome and 100 represents best possible outcome.
Outcome measures
| Measure |
Relaxing Acupressure Plus Usual Care
n=11 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily.The "True Acupressure" points were chosen based on a TCM theory for treating insomnia.
Relaxing acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Stimulating Acupressure Plus Usual Care
n=14 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. Acupoints were chosen by consensus of 4 acupressure practitioners and based on a previous study design in students with sleep disturbances as well as TCM theory for treating insomnia and fatigue.
Stimulating acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Sham Acupressure Plus Usual Care
n=14 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. None of these points are on meridians nor are they on actual points. They were chosen to be in the same general body quadrant as the true points.
Sham acupressure plus usual care: Positive control group. Chosen pressure points are not known to be effective.
|
Usual Care
n=13 Participants
Participants will be asked to continue following their healthcare providers' instruction for chronic SLE management. We anticipate that most women will be treated per the American College of Rheumatology clinical guidelines. Participants will be asked to continue any current treatment and not to start or stop treatments including acupuncture/acupressure over the course of the study. All treatments for pain will be recorded.
Usual care: Negative control group. Participants are asked to carry on with their usual management practices and habits.
|
|---|---|---|---|---|
|
Quality of Life Satisfaction
Physical Functioning
|
74.1 score on a scale
Interval 50.0 to 100.0
|
53.3 score on a scale
Interval 30.0 to 80.0
|
55 score on a scale
Interval 20.0 to 90.0
|
66.4 score on a scale
Interval 30.0 to 100.0
|
|
Quality of Life Satisfaction
Role Limitations due to physical health
|
25 score on a scale
Interval 0.0 to 100.0
|
8.3 score on a scale
Interval 0.0 to 25.0
|
28.6 score on a scale
Interval 0.0 to 100.0
|
39.3 score on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Satisfaction
Role limitations due to emotional problems
|
38.9 score on a scale
Interval 0.0 to 100.0
|
77.8 score on a scale
Interval 33.0 to 100.0
|
52.4 score on a scale
Interval 0.0 to 100.0
|
80.9 score on a scale
Interval 0.0 to 100.0
|
|
Quality of Life Satisfaction
Energy/Fatigue
|
38.3 score on a scale
Interval 30.0 to 55.0
|
26.7 score on a scale
Interval 20.0 to 35.0
|
35.7 score on a scale
Interval 0.0 to 60.0
|
31.4 score on a scale
Interval 0.0 to 80.0
|
|
Quality of Life Satisfaction
Emotional Well-being
|
66 score on a scale
Interval 52.0 to 88.0
|
88 score on a scale
Interval 84.0 to 92.0
|
76 score on a scale
Interval 56.0 to 92.0
|
72.6 score on a scale
Interval 52.0 to 88.0
|
|
Quality of Life Satisfaction
Social Functioning
|
43.7 score on a scale
Interval 25.0 to 50.0
|
54.2 score on a scale
Interval 50.0 to 62.5
|
55.3 score on a scale
Interval 50.0 to 75.0
|
66.1 score on a scale
Interval 50.0 to 100.0
|
|
Quality of Life Satisfaction
Pain
|
60.4 score on a scale
Interval 32.5 to 90.0
|
51.6 score on a scale
Interval 32.5 to 67.5
|
65 score on a scale
Interval 22.5 to 100.0
|
68.2 score on a scale
Interval 32.5 to 100.0
|
|
Quality of Life Satisfaction
General health
|
42.5 score on a scale
Interval 20.0 to 60.0
|
43.3 score on a scale
Interval 25.0 to 75.0
|
40.7 score on a scale
Interval 20.0 to 80.0
|
44.3 score on a scale
Interval 15.0 to 90.0
|
SECONDARY outcome
Timeframe: Four weeks post-treatmentSleep quality will be determined by the Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Total scores range from 0 to 21. Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Relaxing Acupressure Plus Usual Care
n=11 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily.The "True Acupressure" points were chosen based on a TCM theory for treating insomnia.
Relaxing acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Stimulating Acupressure Plus Usual Care
n=14 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. Acupoints were chosen by consensus of 4 acupressure practitioners and based on a previous study design in students with sleep disturbances as well as TCM theory for treating insomnia and fatigue.
Stimulating acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Sham Acupressure Plus Usual Care
n=14 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. None of these points are on meridians nor are they on actual points. They were chosen to be in the same general body quadrant as the true points.
Sham acupressure plus usual care: Positive control group. Chosen pressure points are not known to be effective.
|
Usual Care
n=13 Participants
Participants will be asked to continue following their healthcare providers' instruction for chronic SLE management. We anticipate that most women will be treated per the American College of Rheumatology clinical guidelines. Participants will be asked to continue any current treatment and not to start or stop treatments including acupuncture/acupressure over the course of the study. All treatments for pain will be recorded.
Usual care: Negative control group. Participants are asked to carry on with their usual management practices and habits.
|
|---|---|---|---|---|
|
Sleep Quality
|
9.3 score on a scale
Interval 6.0 to 12.0
|
9.3 score on a scale
Interval 5.0 to 12.0
|
7.6 score on a scale
Interval 4.0 to 10.0
|
10.3 score on a scale
Interval 8.0 to 14.0
|
SECONDARY outcome
Timeframe: Four weeks post-treatmentPain presence, intensity and interference will be determined by the Brief Pain Inventory. The Brief Pain Inventory is an instrument that separately measures pain intensity and interference with physical and emotional functioning, such as sleep, relations with others, and enjoyment of life. Pain intensity is measured on a scale of 0 to 10 where 0 means no pain and 10 means unbearable pain. Pain interference is measured on a scale of 0 - 10, where 0 = does not interfere, 10 = completely interferes.
Outcome measures
| Measure |
Relaxing Acupressure Plus Usual Care
n=11 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily.The "True Acupressure" points were chosen based on a TCM theory for treating insomnia.
Relaxing acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Stimulating Acupressure Plus Usual Care
n=14 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. Acupoints were chosen by consensus of 4 acupressure practitioners and based on a previous study design in students with sleep disturbances as well as TCM theory for treating insomnia and fatigue.
Stimulating acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Sham Acupressure Plus Usual Care
n=14 Participants
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. None of these points are on meridians nor are they on actual points. They were chosen to be in the same general body quadrant as the true points.
Sham acupressure plus usual care: Positive control group. Chosen pressure points are not known to be effective.
|
Usual Care
n=13 Participants
Participants will be asked to continue following their healthcare providers' instruction for chronic SLE management. We anticipate that most women will be treated per the American College of Rheumatology clinical guidelines. Participants will be asked to continue any current treatment and not to start or stop treatments including acupuncture/acupressure over the course of the study. All treatments for pain will be recorded.
Usual care: Negative control group. Participants are asked to carry on with their usual management practices and habits.
|
|---|---|---|---|---|
|
Presence of Pain, Intensity, and Interference
Pain intensity
|
3.7 score on a scale
Interval 1.0 to 6.7
|
5 score on a scale
Interval 4.75 to 5.5
|
3.7 score on a scale
Interval 2.5 to 6.0
|
3.5 score on a scale
Interval 1.25 to 6.0
|
|
Presence of Pain, Intensity, and Interference
Pain Interference
|
3.09 score on a scale
Interval 0.0 to 7.4
|
3.8 score on a scale
Interval 2.3 to 4.7
|
3.1 score on a scale
Interval 0.7 to 6.7
|
2.06 score on a scale
Interval 0.0 to 6.0
|
Adverse Events
Relaxing Acupressure Plus Usual Care
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Stimulating Acupressure Plus Usual Care
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Sham Acupressure Plus Usual Care
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Relaxing Acupressure Plus Usual Care
n=11 participants at risk
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily.The "True Acupressure" points were chosen based on a TCM theory for treating insomnia.
Relaxing acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Stimulating Acupressure Plus Usual Care
n=14 participants at risk
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. Acupoints were chosen by consensus of 4 acupressure practitioners and based on a previous study design in students with sleep disturbances as well as TCM theory for treating insomnia and fatigue.
Stimulating acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Sham Acupressure Plus Usual Care
n=14 participants at risk
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. None of these points are on meridians nor are they on actual points. They were chosen to be in the same general body quadrant as the true points.
Sham acupressure plus usual care: Positive control group. Chosen pressure points are not known to be effective.
|
Usual Care
n=13 participants at risk
Participants will be asked to continue following their healthcare providers' instruction for chronic SLE management. We anticipate that most women will be treated per the American College of Rheumatology clinical guidelines. Participants will be asked to continue any current treatment and not to start or stop treatments including acupuncture/acupressure over the course of the study. All treatments for pain will be recorded.
Usual care: Negative control group. Participants are asked to carry on with their usual management practices and habits.
|
|---|---|---|---|---|
|
Renal and urinary disorders
hospitalized for Kidney stones
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Injury, poisoning and procedural complications
Mild concussion, hospitalized
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
Other adverse events
| Measure |
Relaxing Acupressure Plus Usual Care
n=11 participants at risk
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily.The "True Acupressure" points were chosen based on a TCM theory for treating insomnia.
Relaxing acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Stimulating Acupressure Plus Usual Care
n=14 participants at risk
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. Acupoints were chosen by consensus of 4 acupressure practitioners and based on a previous study design in students with sleep disturbances as well as TCM theory for treating insomnia and fatigue.
Stimulating acupressure plus usual care: Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
|
Sham Acupressure Plus Usual Care
n=14 participants at risk
There is a set of unilateral and bilateral acupoints that will be stimulated for 3 minutes per point giving a total treatment time of about 30 minutes daily. None of these points are on meridians nor are they on actual points. They were chosen to be in the same general body quadrant as the true points.
Sham acupressure plus usual care: Positive control group. Chosen pressure points are not known to be effective.
|
Usual Care
n=13 participants at risk
Participants will be asked to continue following their healthcare providers' instruction for chronic SLE management. We anticipate that most women will be treated per the American College of Rheumatology clinical guidelines. Participants will be asked to continue any current treatment and not to start or stop treatments including acupuncture/acupressure over the course of the study. All treatments for pain will be recorded.
Usual care: Negative control group. Participants are asked to carry on with their usual management practices and habits.
|
|---|---|---|---|---|
|
Infections and infestations
Severe cold and flu
|
0.00%
0/11 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Surgical and medical procedures
outpatient surgery for vericose veins
|
0.00%
0/11 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Infections and infestations
upper respiratory infection
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Product Issues
pain at accupressure points+minor bruising at points
|
0.00%
0/11 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Infections and infestations
sinus cold
|
0.00%
0/11 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Product Issues
Accupressure causing pain in joints of the fingers when applying pressure
|
0.00%
0/11 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Infections and infestations
Bladder infection
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Immune system disorders
Lupus flare
|
0.00%
0/11 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
7.1%
1/14 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Surgical and medical procedures
Root canal
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Surgical and medical procedures
Foot surgery for plantar fascitis
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/13 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
|
Immune system disorders
Lupus flare up
|
0.00%
0/11 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
0.00%
0/14 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
7.7%
1/13 • Number of events 1 • Adverse event data were collected over total of 10 weeks which includes 6 weeks of treatment period and 4 weeks of post-treatment follow-up period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place