跳至主要内容
临床试验/NCT03200548
NCT03200548终止不适用

Acupressure for Persistent Fatigue in Systemic Lupus Erythematosus Patients

Suzanna Zick2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
52
试验地点
2
主要终点
Fatigue Severity and Interference

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Fatigue Severity and Interference

时间窗: 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.

次要结局

  • Presence of Pain, Intensity, and Interference(Four weeks post-treatment)
  • Quality of Life Satisfaction(Four weeks post-treatment)
  • Sleep Quality(Four weeks post-treatment)

研究者

发起方
Suzanna Zick
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Suzanna Zick

Co-Director of Integrative Family Medicine Research Associate Professor Department of Family Medicine

University of Michigan

研究点 (2)

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