Acupressure for Fatigue in Systemic Lupus Erythematosus

NCT ID: NCT03200548

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2019-07-19

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Relaxing acupressure plus usual care

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.

Group Type: EXPERIMENTAL

Relaxing acupressure plus usual care

Intervention Type: BEHAVIORAL

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.

Stimulating acupressure plus usual care

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.

Group Type: EXPERIMENTAL

Stimulating acupressure plus usual care

Intervention Type: BEHAVIORAL

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

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.

Group Type: SHAM_COMPARATOR

Sham acupressure plus usual care

Intervention Type: BEHAVIORAL

Positive control group. Chosen pressure points are not known to be effective.

Usual care

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.

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Negative control group. Participants are asked to carry on with their usual management practices and habits.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual care

Negative control group. Participants are asked to carry on with their usual management practices and habits.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Sham acupressure plus usual care

Positive control group. Chosen pressure points are not known to be effective.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Suzanna Zick

OTHER

Sponsor Role: lead

Responsible Party

Suzanna Zick

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Suzanna M Zick, ND, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Domino's Farms

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27388752 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22909076 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20924499 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16131291 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16761508 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20699243 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22972087 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16565098 (View on PubMed)

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.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00127631

Identifier Type: -

Identifier Source: org_study_id