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Acupressure for Fatigue in Systemic Lupus Erythematosus

Acupressure for Persistent Fatigue in Systemic Lupus Erythematosus Patients

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03200548
Acronym
AcuSLE
Enrollment
52
Registered
2017-06-27
Start date
2017-08-14
Completion date
2019-07-19
Last updated
2023-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Lupus Erythematosus, Systemic, Pain, Chronic, Quality of Life, Sleep

Brief summary

Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterized by involvement of multiple organs with a female to male ratio of 12:1 with the highest incidence reported in women of child bearing age (15-44 years). In general, advances in diagnosis and management have led to significant improvements in outcomes. However, fatigue remains a challenging and prevalent issue for SLE patients. The investigators aim to determine the feasibility of recruiting and conducting acupressure in fatigued persons with lupus; to explore the effect of two distinct acupressure formulas (relaxing and stimulating) plus usual care versus sham acupressure plus usual care and usual care alone on severity and impact of chronic fatigue (as measured by the Brief Fatigue Inventory) as well as quality of life, sleep and pain.

Detailed description

Self-administered acupressure is one possible safe, self-management technique that 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. Our prior research demonstrated that acupressure, self-administered by women with breast cancer, significantly reduced clinically significant fatigue by approximately one-third in fatigued breast cancer survivors and was superior to standard therapies. Moreover these self-rated improvements were maintained up to one month after treatment was discontinued. However, impact on other chronic disease populations with fatigue is unknown. To explore this intervention in SLE, the investigators are conducting a pilot randomized clinical trial among 72 SLE patients with established fatigue. The study will take place over the course of 12 weeks, including 5 participant interactions. After completing the initial screening phone call, participant eligibility will be determined. If a participant is found ineligible then his or her participation in the study will end. If a participant is found eligible he or she may continue participation by attending the baseline visit during which participants will be randomized into one of four groups, three of which will be some type of acupressure and one which will be usual care. In three of these groups participants will be taught how to perform acupressure and where your acupressure points are located by study staff members that have been trained by a certified acupressure practitioner. Each treatment group uses a different set of acupressure points and is instructed how to effectively stimulate those different points. The study staff member will demonstrate on the participant how much pressure to apply at an acupressure point and will observe the participant locating each acupressure point. Participants will also be given information to take home showing them where these acupressure points are placed on the body. As part of this study, participants will be asked to attend 2 visits, answer phone calls or emails, and (if randomized to a treatment group) perform acupressure daily. There is also a follow-up visit or telephone call conducted at least 4 weeks after the last visit.

Interventions

BEHAVIORALRelaxing 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.

BEHAVIORALUsual care

Negative control group. Participants are asked to carry on with their usual management practices and habits.

BEHAVIORALStimulating 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.

BEHAVIORALSham acupressure plus usual care

Positive control group. Chosen pressure points are not known to be effective.

Sponsors

University of Michigan
CollaboratorOTHER
Suzanna Zick
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

The three acupressure formulas will be labeled acupressure set A, set B, and set C. Acupressure educators, outcome assessors, study participants, and study investigators (who will not interact with any of the study participants) will be blinded as to acupressure allocation. Only after data analysis is completed will the randomization code be unblinded. Those randomized to usual care will know that they are not receiving acupressure.

Intervention model description

The investigators propose to perform a randomized, single-blind parallel clinical trial. This will be parallel design with four arms (relaxing acupressure plus usual care, stimulating acupressure plus usual care, sham acupressure plus usual care and usual care alone) for persistent fatigue in SLE.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Report chronic (\> 3 months) clinically relevant fatigue, defined as a score of ≥ 4 on the Brief Fatigue Inventory (BFI) * Have inactive disease, defined as SELENA SLEDAI ≤ 4 AND/OR no hospitalization or addition or increase in dose of corticosteroids, immunosuppressive agents, or antimalarial medications in the last 30 days. * Have no commonly recognized medical explanations for fatigue (a history of cancer in the previous 5 years -except certain low risk cancer, unstable thyroid disease, moderate to severe chronic kidney disease, moderate to severe anemia) * Are taking stable doses of anti-malarial therapy (hydroxychloroquine, quinacrine) for at least 6 months. * Baseline glucocorticoid dose equivalent of ≤ 10 mg prednisone. * No other planned intervention for fatigue other than current stable medication regimen

Exclusion criteria

* Pregnant or breast feeding * Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive disorder * Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy etc., or any planned change of medications, supplements or therapies during the study * Acupuncture or acupressure receipt in past year

Design outcomes

Primary

MeasureTime frameDescription
Fatigue Severity and InterferenceFour weeks post-treatmentFatigue 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.

Secondary

MeasureTime frameDescription
Quality of Life SatisfactionFour 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.
Sleep QualityFour 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.
Presence of Pain, Intensity, and InterferenceFour 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.

Countries

United States

Participant flow

Pre-assignment details

One participant who was consented but did not actually begin the intervention.

Participants by arm

ArmCount
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.
11
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.
14
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.
14
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.
13
Total52

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyWithdrawal by Subject51176

Baseline characteristics

CharacteristicRelaxing Acupressure Plus Usual CareStimulating Acupressure Plus Usual CareSham Acupressure Plus Usual CareUsual CareTotal
Age, Continuous49.4 years47.3 years53.3 years46.5 years49.1 years
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants2 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants14 Participants12 Participants13 Participants50 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Lupus flare severity categorization
Mild
2 Participants3 Participants6 Participants3 Participants14 Participants
Lupus flare severity categorization
Moderate
2 Participants5 Participants4 Participants4 Participants15 Participants
Lupus flare severity categorization
No
5 Participants5 Participants3 Participants4 Participants17 Participants
Lupus flare severity categorization
Severe
2 Participants1 Participants1 Participants2 Participants6 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Black
2 Participants5 Participants3 Participants4 Participants14 Participants
Race/Ethnicity, Customized
Other
0 Participants1 Participants1 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Unknown & Refused
0 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
White
9 Participants8 Participants10 Participants9 Participants36 Participants
Region of Enrollment
United States
11 Participants14 Participants14 Participants13 Participants52 Participants
Sex: Female, Male
Female
11 Participants14 Participants14 Participants13 Participants52 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 110 / 140 / 140 / 13
other
Total, other adverse events
3 / 113 / 142 / 141 / 13
serious
Total, serious adverse events
2 / 110 / 140 / 140 / 13

Outcome results

Primary

Fatigue Severity and Interference

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.

Time frame: Four weeks post-treatment

Population: This is an intent to treat analysis.

ArmMeasureValue (MEAN)
Relaxing Acupressure Plus Usual CareFatigue Severity and Interference3.8 score on a scale
Stimulating Acupressure Plus Usual CareFatigue Severity and Interference4.3 score on a scale
Sham Acupressure Plus Usual CareFatigue Severity and Interference3.7 score on a scale
Usual CareFatigue Severity and Interference4.6 score on a scale
Secondary

Presence of Pain, Intensity, and Interference

Pain 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.

Time frame: Four weeks post-treatment

ArmMeasureGroupValue (MEAN)
Relaxing Acupressure Plus Usual CarePresence of Pain, Intensity, and InterferencePain intensity3.7 score on a scale
Relaxing Acupressure Plus Usual CarePresence of Pain, Intensity, and InterferencePain Interference3.09 score on a scale
Stimulating Acupressure Plus Usual CarePresence of Pain, Intensity, and InterferencePain Interference3.8 score on a scale
Stimulating Acupressure Plus Usual CarePresence of Pain, Intensity, and InterferencePain intensity5 score on a scale
Sham Acupressure Plus Usual CarePresence of Pain, Intensity, and InterferencePain intensity3.7 score on a scale
Sham Acupressure Plus Usual CarePresence of Pain, Intensity, and InterferencePain Interference3.1 score on a scale
Usual CarePresence of Pain, Intensity, and InterferencePain intensity3.5 score on a scale
Usual CarePresence of Pain, Intensity, and InterferencePain Interference2.06 score on a scale
Secondary

Quality of Life Satisfaction

Quality 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.

Time frame: Four weeks post-treatment

ArmMeasureGroupValue (MEAN)
Relaxing Acupressure Plus Usual CareQuality of Life SatisfactionRole limitations due to emotional problems38.9 score on a scale
Relaxing Acupressure Plus Usual CareQuality of Life SatisfactionGeneral health42.5 score on a scale
Relaxing Acupressure Plus Usual CareQuality of Life SatisfactionEmotional Well-being66 score on a scale
Relaxing Acupressure Plus Usual CareQuality of Life SatisfactionEnergy/Fatigue38.3 score on a scale
Relaxing Acupressure Plus Usual CareQuality of Life SatisfactionRole Limitations due to physical health25 score on a scale
Relaxing Acupressure Plus Usual CareQuality of Life SatisfactionPhysical Functioning74.1 score on a scale
Relaxing Acupressure Plus Usual CareQuality of Life SatisfactionPain60.4 score on a scale
Relaxing Acupressure Plus Usual CareQuality of Life SatisfactionSocial Functioning43.7 score on a scale
Stimulating Acupressure Plus Usual CareQuality of Life SatisfactionEnergy/Fatigue26.7 score on a scale
Stimulating Acupressure Plus Usual CareQuality of Life SatisfactionPhysical Functioning53.3 score on a scale
Stimulating Acupressure Plus Usual CareQuality of Life SatisfactionRole Limitations due to physical health8.3 score on a scale
Stimulating Acupressure Plus Usual CareQuality of Life SatisfactionRole limitations due to emotional problems77.8 score on a scale
Stimulating Acupressure Plus Usual CareQuality of Life SatisfactionEmotional Well-being88 score on a scale
Stimulating Acupressure Plus Usual CareQuality of Life SatisfactionSocial Functioning54.2 score on a scale
Stimulating Acupressure Plus Usual CareQuality of Life SatisfactionPain51.6 score on a scale
Stimulating Acupressure Plus Usual CareQuality of Life SatisfactionGeneral health43.3 score on a scale
Sham Acupressure Plus Usual CareQuality of Life SatisfactionPhysical Functioning55 score on a scale
Sham Acupressure Plus Usual CareQuality of Life SatisfactionEmotional Well-being76 score on a scale
Sham Acupressure Plus Usual CareQuality of Life SatisfactionGeneral health40.7 score on a scale
Sham Acupressure Plus Usual CareQuality of Life SatisfactionSocial Functioning55.3 score on a scale
Sham Acupressure Plus Usual CareQuality of Life SatisfactionRole Limitations due to physical health28.6 score on a scale
Sham Acupressure Plus Usual CareQuality of Life SatisfactionPain65 score on a scale
Sham Acupressure Plus Usual CareQuality of Life SatisfactionEnergy/Fatigue35.7 score on a scale
Sham Acupressure Plus Usual CareQuality of Life SatisfactionRole limitations due to emotional problems52.4 score on a scale
Usual CareQuality of Life SatisfactionGeneral health44.3 score on a scale
Usual CareQuality of Life SatisfactionEnergy/Fatigue31.4 score on a scale
Usual CareQuality of Life SatisfactionEmotional Well-being72.6 score on a scale
Usual CareQuality of Life SatisfactionRole Limitations due to physical health39.3 score on a scale
Usual CareQuality of Life SatisfactionPain68.2 score on a scale
Usual CareQuality of Life SatisfactionPhysical Functioning66.4 score on a scale
Usual CareQuality of Life SatisfactionSocial Functioning66.1 score on a scale
Usual CareQuality of Life SatisfactionRole limitations due to emotional problems80.9 score on a scale
Secondary

Sleep Quality

Sleep 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.

Time frame: Four weeks post-treatment

ArmMeasureValue (MEAN)
Relaxing Acupressure Plus Usual CareSleep Quality9.3 score on a scale
Stimulating Acupressure Plus Usual CareSleep Quality9.3 score on a scale
Sham Acupressure Plus Usual CareSleep Quality7.6 score on a scale
Usual CareSleep Quality10.3 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026