Evaluating the Effectiveness of Acupressure in Relieving Pruritus Related to Atopic Dermatitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score
Study Overview
Brief Summary
The purpose of this study is to see if acupressure will be effective at reducing itch in people with atopic dermatitis (AD).
Detailed Description
Atopic dermatitis (AD) is recognized as a major and common problem worldwide. In the United States, AD and related eczematous symptoms affect 17% of the population; 1 in 10 individuals report having experienced symptoms causing quality of life (QOL) distress, including itching/scratching, red/inflamed rash, excessive dryness/scaling, and/or symptoms lasting ≥ 14 days. Two-thirds of these subjects noted at least moderate to severe symptoms, with itch being the most disturbing. Effective treatment of AD and of pruritus (itching) are interconnected. Treating AD will decrease the stimulus for the itch, whereas treating pruritus will decrease the feedback cycle brought on when a patient scratches the skin continually. Effective medications for AD and related symptoms include topical corticosteroids and calcineurin inhibitors. Oftentimes, these remedies are insufficient at treating the itch component of the disease. There is demand for alternative, complementary treatments for AD-related pruritus.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of AD by dermatologist
- •Not currently using acupressure or acupuncture for treatment of AD
- •Able to read, write, and understand study materials
- •Age 18 or older
Exclusion Criteria
- •Unable to physically perform acupressure technique
- •Significant comorbidities causing itch such as chronic urticaria, renal failure, notalgia paresthetica, and tinea
Arms & Interventions
Control group
This group of subjects will serve as the control group and will follow a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
Intervention: Standard-of-care treatment for AD (Other)
Accu-patch pellet
This group of subjects will follow a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they will use a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
Intervention: Accu-patch pellet (Device)
Outcomes
Primary Outcomes
Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score
Time Frame: Baseline and 4 weeks
The VAS score assesses itch intensity in subject's with AD. The VAS consists of a 21.5 cm horizontal line with its left and right boundaries marked by vertical lines. The left boundary vertical line is labeled "Least Itch," and the right boundary vertical line is labeled "Worst Itch." Subjects are instructed to draw a vertical line across this scale that represents the intensity of itch that they are currently experiencing. Vertical lines drawn by subjects towards the left boundary of the horizontal line are associated with less itch intensity, and vertical lines drawn by subjects towards the right boundary of the horizontal line are associated with worse itch intensity. A ruler is then used to measure distance from the left boundary vertical line to the vertical line drawn by the subject to the nearest millimeter. Possible values range from 0 to 21.5 centimeters, with 0 centimeters associated with less itch intensity and 21.5 cm associated with worse itch intensity.
Secondary Outcomes
- Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score(Baseline and 4 weeks)
- Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Area Subscale Score(Baseline and 4 weeks)
- Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Erythema Subscale Score(Baseline and 4 weeks)
- Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Infiltration/Papulation Subscale Score(Baseline and 4 weeks)
- Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Excoriation Subscale Score(Baseline and 4 weeks)
- Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Eczema Area and Severity Index (EASI): Lichenification Subscale Score(Baseline and 4 weeks)
Investigators
Dennis West
Professor of Dermatology and Pediatrics
Northwestern University