Acupressure for Fatigue in Systemic Lupus Erythematosus (AcuSLE)

Suzanna Zick

Status: Terminated

Conditions: Lupus Erythematosus, Systemic; Quality of Life; Pain, Chronic; Fatigue; Sleep

Treatments: Behavioral: Stimulating acupressure plus usual care; Behavioral: Usual care; Behavioral: Relaxing acupressure plus usual care; Behavioral: Sham acupressure plus usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03200548

HUM00127631

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 4 patient groups, including a placebo group

Relaxing acupressure plus usual care

Experimental group

Description:

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.

Treatment:

Behavioral: Relaxing acupressure plus usual care

Stimulating acupressure plus usual care

Experimental group

Description:

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.

Treatment:

Behavioral: Stimulating acupressure plus usual care

Sham acupressure plus usual care

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Sham acupressure plus usual care

Usual care

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Usual care