Acupressure for Fatigue in Systemic Lupus Erythematosus

Quality of Life Clinical Trial

— AcuSLE  

Official title:

Acupressure for Persistent Fatigue in Systemic Lupus Erythematosus Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03200548
• Other study ID #: HUM00127631
• Status: Terminated
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: July 19, 2019

Study information

• Verified date: June 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Relaxing acupressure plus usual care
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.
• Usual care
Negative control group. Participants are asked to carry on with their usual management practices and habits.
• Stimulating acupressure plus usual care
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.
• Sham acupressure plus usual care
Positive control group. Chosen pressure points are not known to be effective.

Locations

Country	Name	City	State
United States	Domino's Farms	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Suzanna Zick	University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

Cheuk DK, Yeung WF, Chung KF, Wong V. Acupuncture for insomnia. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD005472. doi: 10.1002/14651858.CD005472.pub3. — View 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. — View 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. — View 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. — View 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.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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