Clinical trial NCT03200548: Acupressure for Fatigue in Systemic Lupus Erythematosus
Official title: Acupressure for Persistent Fatigue in Systemic Lupus Erythematosus Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fatigue
Lupus Erythematosus, Systemic
Pain, Chronic
Quality of Life
Sleep
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2017-06-27
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue Severity and Interference
timeFrame: Four weeks post-treatment
Secondary outcomes:
measure: Quality of Life Satisfaction
timeFrame: Four weeks post-treatment
measure: Sleep Quality
timeFrame: Four weeks post-treatment
measure: Presence of Pain, Intensity, and Interference
timeFrame: Four weeks post-treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Domino's Farms
state: Michigan
Study officials:
affiliation: University of Michigan
name: Suzanna M Zick, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zick SM, Sen A, Wyatt GK, Murphy SL, Arnedt JT, Harris RE. Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial. JAMA Oncol. 2016 Nov 1;2(11):1470-1476. doi: 10.1001/jamaoncol.2016.1867.
citation: Zick SM, Wyatt GK, Murphy SL, Arnedt JT, Sen A, Harris RE. Acupressure for persistent cancer-related fatigue in breast cancer survivors (AcuCrft): a study protocol for a randomized controlled trial. BMC Complement Altern Med. 2012 Aug 21;12:132. doi: 10.1186/1472-6882-12-132.
citation: Zick SM, Alrawi S, Merel G, Burris B, Sen A, Litzinger A, Harris RE. Relaxation acupressure reduces persistent cancer-related fatigue. Evid Based Complement Alternat Med. 2011;2011:142913. doi: 10.1155/2011/142913. Epub 2010 Sep 2.
citation: Harris RE, Jeter J, Chan P, Higgins P, Kong FM, Fazel R, Bramson C, Gillespie B. Using acupressure to modify alertness in the classroom: a single-blinded, randomized, cross-over trial. J Altern Complement Med. 2005 Aug;11(4):673-9. doi: 10.1089/acm.2005.11.673.
citation: Danchenko N, Satia JA, Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus. 2006;15(5):308-18. doi: 10.1191/0961203306lu2305xx.
citation: Bertsias GK, Salmon JE, Boumpas DT. Therapeutic opportunities in systemic lupus erythematosus: state of the art and prospects for the new decade. Ann Rheum Dis. 2010 Sep;69(9):1603-11. doi: 10.1136/ard.2010.135186.
citation: Cheuk DK, Yeung WF, Chung KF, Wong V. Acupuncture for insomnia. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD005472. doi: 10.1002/14651858.CD005472.pub3.
citation: Frost H, Stewart-Brown S. Acupressure for low back pain. BMJ. 2006 Mar 25;332(7543):680-1. doi: 10.1136/bmj.332.7543.680. No abstract available.
citation: Kim YC, Lee MS, Park E-S, Lew J-H, Lee B-J. Acupressure for the Treatment of Musculoskeletal Pain Conditions: A Systematic Review. Journal of Musculoskeletal Pain 20 (2): 116-121, 2012.