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Acupressure for Fatigue in Systemic Lupus Erythematosus (AcuSLE)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Suzanna Zick, University of Michigan
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Suzanna Zick, University of Michigan
ClinicalTrials.gov Identifier:
NCT03200548
First received: June 23, 2017
Last updated: August 16, 2017
Last verified: August 2017
  Purpose

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.


Condition Intervention
Fatigue Lupus Erythematosus, Systemic Pain, Chronic Quality of Life Sleep Behavioral: Relaxing acupressure plus usual care Behavioral: Usual care Behavioral: Stimulating acupressure plus usual care Behavioral: Sham acupressure plus usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Official Title: Acupressure for Persistent Fatigue in Systemic Lupus Erythematosus Patients

Resource links provided by NLM:


Further study details as provided by Suzanna Zick, University of Michigan:

Primary Outcome Measures:
  • Fatigue [ Time Frame: Four weeks post-treatment ]
    Fatigue severity will be determined according the Brief Fatigue Inventory questionnaire.


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Four weeks post-treatment ]
    Quality of Life will be determined by the Satisfaction With Life Scale.

  • Sleep [ Time Frame: Four weeks post-treatment ]
    Sleep will be determined by the Pittsburgh Sleep Quality Index.

  • Pain [ Time Frame: Four weeks post-treatment ]
    Pain will be determined by the Brief Pain Inventory.


Estimated Enrollment: 72
Actual Study Start Date: August 14, 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: 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.
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.
Sham Comparator: 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.
Behavioral: Sham acupressure plus usual care
Positive control group. Chosen pressure points are not known to be effective.
Placebo Comparator: 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.
Behavioral: Usual care
Negative control group. Participants are asked to carry on with their usual management practices and habits.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women aged 18 years and older
Accepts Healthy Volunteers:   Yes
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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03200548

Contacts
Contact: Suzanna M Zick, ND, MPH (734) 998-9553 fammed-szickstudy@med.umich.edu
Contact: Tohfa Khabir, BS (734) 998-0031 fammed-szickstudy@med.umich.edu

Locations
United States, Michigan
Domino's Farms Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Suzanna M Zick, ND, MPH    734-998-9553    szick@med.umich.edu   
Contact: Tohfa Khabir    734-998-0031    tohfa@med.umich.edu   
Sponsors and Collaborators
Suzanna Zick
University of Michigan
Investigators
Principal Investigator: Suzanna M Zick, ND, MPH University of Michigan
  More Information

Publications:
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.

Responsible Party: Suzanna Zick, Co-Director of Integrative Family Medicine Research Associate Professor Department of Family Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03200548     History of Changes
Other Study ID Numbers: HUM00127631
Study First Received: June 23, 2017
Last Updated: August 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fatigue
Lupus Erythematosus, Systemic
Chronic Pain
Signs and Symptoms
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2017