NCT03200548: AcuSLE

Acupressure for Fatigue in Systemic Lupus Erythematosus

Terminated NA Results posted Last updated 12 May 2023

What this trial tests

NA trial testing Relaxing acupressure plus usual care in Fatigue in 52 participants. Terminated before completion.

Timeline

14 August 2017

Primary endpoint
19 July 2019

19 July 2019

Quick facts

Lead sponsor	Suzanna Zick
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	52
Start date	14 August 2017
Primary completion	19 July 2019
Estimated completion	19 July 2019
Sites	1 location across United States

Drugs / interventions tested

• Relaxing acupressure plus usual care
• Usual care
• Stimulating acupressure plus usual care
• Sham acupressure plus usual care

Conditions studied

• Fatigue — all drugs for Fatigue →
• Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →
• Pain, Chronic — all drugs for Pain, Chronic →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Suzanna Zick

Who can join

18 and older, female only, with Fatigue or Lupus Erythematosus, Systemic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fatigue Severity and Interference Primary · Four weeks post-treatment

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.

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	3.8	0.1 – 6.9
Stimulating Acupressure Plus Usual Care	4.3	3.4 – 5
Sham Acupressure Plus Usual Care	3.7	1.4 – 6.8
Usual Care	4.6	2 – 7.9

Quality of Life Satisfaction Secondary · Four weeks post-treatment

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.

Physical Functioning

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	74.1	50 – 100
Stimulating Acupressure Plus Usual Care	53.3	30 – 80
Sham Acupressure Plus Usual Care	55	20 – 90
Usual Care	66.4	30 – 100

Role Limitations due to physical health

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	25	0 – 100
Stimulating Acupressure Plus Usual Care	8.3	0 – 25
Sham Acupressure Plus Usual Care	28.6	0 – 100
Usual Care	39.3	0 – 100

Role limitations due to emotional problems

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	38.9	0 – 100
Stimulating Acupressure Plus Usual Care	77.8	33 – 100
Sham Acupressure Plus Usual Care	52.4	0 – 100
Usual Care	80.9	0 – 100

Energy/Fatigue

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	38.3	30 – 55
Stimulating Acupressure Plus Usual Care	26.7	20 – 35
Sham Acupressure Plus Usual Care	35.7	0 – 60
Usual Care	31.4	0 – 80

Emotional Well-being

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	66	52 – 88
Stimulating Acupressure Plus Usual Care	88	84 – 92
Sham Acupressure Plus Usual Care	76	56 – 92
Usual Care	72.6	52 – 88

Social Functioning

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	43.7	25 – 50
Stimulating Acupressure Plus Usual Care	54.2	50 – 62.5
Sham Acupressure Plus Usual Care	55.3	50 – 75
Usual Care	66.1	50 – 100

Pain

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	60.4	32.5 – 90
Stimulating Acupressure Plus Usual Care	51.6	32.5 – 67.5
Sham Acupressure Plus Usual Care	65	22.5 – 100
Usual Care	68.2	32.5 – 100

General health

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	42.5	20 – 60
Stimulating Acupressure Plus Usual Care	43.3	25 – 75
Sham Acupressure Plus Usual Care	40.7	20 – 80
Usual Care	44.3	15 – 90

Sleep Quality Secondary · Four weeks post-treatment

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.

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	9.3	6 – 12
Stimulating Acupressure Plus Usual Care	9.3	5 – 12
Sham Acupressure Plus Usual Care	7.6	4 – 10
Usual Care	10.3	8 – 14

Presence of Pain, Intensity, and Interference Secondary · Four weeks post-treatment

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.

Pain intensity

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	3.7	1 – 6.7
Stimulating Acupressure Plus Usual Care	5	4.75 – 5.5
Sham Acupressure Plus Usual Care	3.7	2.5 – 6
Usual Care	3.5	1.25 – 6

Pain Interference

Group	Value	95% CI
Relaxing Acupressure Plus Usual Care	3.09	0 – 7.4
Stimulating Acupressure Plus Usual Care	3.8	2.3 – 4.7
Sham Acupressure Plus Usual Care	3.1	0.7 – 6.7
Usual Care	2.06	0 – 6

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Relaxing Acupressure Plus Usual Care

Serious: 2/11 (18%)

Deaths: 0/11

Stimulating Acupressure Plus Usual Care

Serious: 0/14 (0%)

Deaths: 0/14

Sham Acupressure Plus Usual Care

Serious: 0/14 (0%)

Deaths: 0/14

Usual Care

Serious: 0/13 (0%)

Deaths: 0/13

Serious adverse events (2 terms)

Reaction	System	Relaxing Acupressure Plus …	Stimulating Acupressure Pl…	Sham Acupressure Plus Usua…	Usual Care
hospitalized for Kidney stones	Renal and urinary disorders	—	—	—	—
Mild concussion, hospitalized	Injury, poisoning and procedural complications	—	—	—	—

Other adverse events (12 terms — click to expand)

Reaction	System	Relaxing Acupressure Plus …	Stimulating Acupressure Pl…	Sham Acupressure Plus Usua…	Usual Care
Severe cold and flu	Infections and infestations	—	—	—	—
outpatient surgery for vericose veins	Surgical and medical procedures	—	—	—	—
upper respiratory infection	Infections and infestations	—	—	—	—
pain at accupressure points+minor bruising at points	Product Issues	—	—	—	—
sinus cold	Infections and infestations	—	—	—	—
Accupressure causing pain in joints of the fingers when applying pressure	Product Issues	—	—	—	—
Bladder infection	Infections and infestations	—	—	—	—
Lupus flare	Immune system disorders	—	—	—	—
Root canal	Surgical and medical procedures	—	—	—	—
Foot surgery for plantar fascitis	Surgical and medical procedures	—	—	—	—
Lupus flare	Immune system disorders	—	—	—	—
Lupus flare up	Immune system disorders	—	—	—	—

Most-reported serious reactions: hospitalized for Kidney stones, Mild concussion, hospitalized.

Data from ClinicalTrials.gov NCT03200548 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.