Acupressure for Fatigue in Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acupressure for Persistent Fatigue in Systemic Lupus Erythematosus Patients

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

Intervention / Treatment
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* Behavioral: Relaxing acupressure plus usual care
* Behavioral: Usual care
* Behavioral: Stimulating acupressure plus usual care
* Behavioral: Sham acupressure plus usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relaxing acupressure plus usual care<br>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. | Behavioral: Relaxing acupressure plus usual care<br>* 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.<br>|
| Experimental: Stimulating acupressure plus usual care<br>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. | Behavioral: Stimulating acupressure plus usual care<br>* 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.<br>|
| Sham Comparator: Sham acupressure plus usual care<br>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. | Behavioral: Sham acupressure plus usual care<br>* Positive control group. Chosen pressure points are not known to be effective.<br>|
| Placebo Comparator: Usual care<br>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. | Behavioral: Usual care<br>* Negative control group. Participants are asked to carry on with their usual management practices and habits.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Four weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Four weeks post-treatment | 
| 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. | Four weeks post-treatment | 
| 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. | Four weeks post-treatment |