Acupressure for Fatigue in Systemic Lupus Erythematosus

NCT03200548 | Terminated Results

• 1 other identifier: HUM00127631
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of Life Satisfaction

  Four weeks post-treatment

• Sleep Quality

  Four weeks post-treatment

• Presence of Pain, Intensity, and Interference

  Four weeks post-treatment

Study Arms (4)

Relaxing acupressure plus usual care

EXPERIMENTAL

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

Stimulating acupressure plus usual care

EXPERIMENTAL

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

Sham acupressure plus usual care

SHAM COMPARATOR

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

Usual care

PLACEBO COMPARATOR

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

Interventions

Relaxing acupressure plus usual care 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.

Relaxing acupressure plus usual care

Usual care BEHAVIORAL

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

Usual care

Stimulating acupressure plus usual care 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

Sham acupressure plus usual care BEHAVIORAL

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

Sham acupressure plus usual care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women aged 18 years and older
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzanna Zick: lead
• University of Michigan: collaborator

Study Sites (1)

Domino's Farms

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (9)

• 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.

  PMID: 27388752 BACKGROUND

• 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.

  PMID: 22909076 BACKGROUND

• 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.

  PMID: 20924499 BACKGROUND

• 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.

  PMID: 16131291 BACKGROUND

• 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.

  PMID: 16761508 BACKGROUND

• 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.

  PMID: 20699243 BACKGROUND

• 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.

  PMID: 22972087 BACKGROUND

• 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.

  PMID: 16565098 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Fatigue; Lupus Erythematosus, Systemic; Chronic Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations

Results Point of Contact

• Title: Suzanna Zick
• Organization: University of Michigan

szick@med.umich.edu

734-998-9553

Study Officials

• Suzanna M Zick, ND, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Director of Integrative Family Medicine Research Associate Professor Department of Family Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: June 27, 2017
• Study Start: August 14, 2017
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: May 12, 2023
• Results First Posted: May 12, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)