Acupressure in Pruritus for Atopic Dermatitis

Evaluating the Effectiveness of Acupressure in Relieving Pruritus Related to Atopic Dermatitis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01074164

Enrollment

Registered

2010-02-24

Start date

2010-02-28

Completion date

2010-12-31

Last updated

2015-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

eczema, atopic dermatitis, itch, pruritus, acupressure, acupuncture

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.

Interventions

OTHERStandard-of-care treatment for AD

Subjects will receive standard of care treatment for atopic dermatitis, including moisturizers and topical corticosteroids, per their dermatologist.

DEVICEAccu-patch pellet

The accu-patch pellets will be applied to the LI11 pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times a week for 1 month.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score	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

Measure	Time frame	Description
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	The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining area subscale score, the percent area of skin involvement is determined and assigned a score of 0 to 6, where 0 correlates with no skin involvement, 1 represents \< 10% skin involvement, 2 represents 10-29% skin involvement, 3 represents 30-49% skin involvement, 4 represents 50-69% skin involvement, 5 represents 70-89% skin involvement, and 6 represents 90-100% skin involvement. Possible scores range from 0 to 6, where 0 correlates with better disease severity and 6 correlates with worse disease severity. Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18.
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	The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the erythema subscale score, erythema is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity. Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18.
Change in Severity of Atopic Dermatitis (AD) as Measured by a Change in Investigator Global Assessment (IGA) Score	Baseline and 4 weeks	The IGA score is an assessment of AD severity. It is an assessment of the patient's disease state at the time of examination and does not attempt a comparison with any of the patient's previous disease states. Possible scores range from 0 to 5. A score of 0 is associated with no evidence of AD and a score of 5 is associated with severe AD.
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	The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the excoriation subscale score, excoriation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity. Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18.
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	The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the lichenification subscale score, lichenification is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity. Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18.
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	The EASI is a composite score assessing four key clinical signs of AD and the area of skin involvement in four main body regions (head, trunk, upper limbs, and lower limbs). The 5 EASI subscales are: erythema, infiltration/papulation, excoriation, lichenification, and percent area of skin involvement. For determining the infiltration/papulation subscale score, infiltration/papulation is assessed in each main body region and assigned a score of 0 to 3, where a score of 0 is associated with no expression of the clinical sign and a score of 3 is associated with severe expression of the clinical sign. Possible scores range from 0 to 3, where 0 correlates with better disease severity and 3 correlates with worse disease severity. Hanifin JM, Thurston M, Omoto M, et al (2001) The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. Exp Dermatol; 10: 11-18.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Control Group This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.	7
Accu-patch Pellet This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used 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.	8
Total	15

Baseline characteristics

Characteristic	Total	Control Group	Accu-patch Pellet
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	1 Participants	0 Participants
Age, Categorical Between 18 and 65 years	14 Participants	6 Participants	8 Participants
Age, Continuous	37.3 years STANDARD_DEVIATION 15.2	39.7 years STANDARD_DEVIATION 18.3	35.1 years STANDARD_DEVIATION 11.3
Region of Enrollment United States	15 participants	7 participants	8 participants
Sex: Female, Male Female	5 Participants	1 Participants	4 Participants
Sex: Female, Male Male	10 Participants	6 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 7	0 / 8
serious Total, serious adverse events	0 / 7	0 / 8

Outcome results

Primary

Change in Itch Intensity as Measured by a Change in Visual Analog Scale (VAS) Score

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.