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Laser Acupuncture Versus Tap Water Iontophoresis on Hyperhidrosis

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laser Acupoint
Tap water iontophoresis
Sponsored by
Kafrelsheikh University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis

Eligibility Criteria

18 Years - 22 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • volunteer subjects from MIT physical therapy students complained from hyperhidrosis examined by Hyperhidrosis Disease Severity Scale, Perceived Stress Scale.

Exclusion Criteria:

  • Subjects will be excluded if they had musculoskeletal diseases and visceral disorders or had any operations or recent injury

Sites / Locations

  • Kafrelshaikh University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser Acupoint

Tap water iontophoresis

Arm Description

Laser will be performed 3 times per week for 2-week measurement. The duration of each cession will be 10 minutes treatment.

Tap water iontophoresis will be performed 3 times per week for 2-weeks. The duration of each cession will be 20 minutes treatment session.

Outcomes

Primary Outcome Measures

Hyperhidrosis Disease Severity Scale
The Hyperhidrosis Disease Severity Scale (HDSS) is a disease-specific, quick, and easily-understood diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. Ask the patient to select the statement above that best reflects his or her experience with sweating of the specified body area. Next to each statement is a number. A score of 3 or 4 indicates severe hyperhidrosis. A score of 1 or 2 indicates mild or moderate hyperhidrosis.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2021
Last Updated
September 8, 2021
Sponsor
Kafrelsheikh University
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1. Study Identification

Unique Protocol Identification Number
NCT04862546
Brief Title
Laser Acupuncture Versus Tap Water Iontophoresis on Hyperhidrosis
Official Title
Effect of Acupuncture Points Laser Versus Tap Water Iontophoresis on Hyperhidrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 9, 2021 (Actual)
Study Completion Date
September 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
the purpose of the present study is to assess the effect of laser acupoints on subjects with hyperhidrosis in comparison to tap water iontophoresis
Detailed Description
The study will be randomized control trial pre and post-experimental design. Anonymity and confidentiality of all procedures will be assured in compliance with relevant laws and institutional guidelines. All patients will sign two copies of a consent form before the beginning of data collection. Subjects will be recruited using publicly distributed posters and by online social media, subjects their hyperhidrosis examined by Hyperhidrosis Disease Severity Scale, Perceived Stress Scale. Recruited subjects will be randomly assigned to Laser Acupoint or Tap water iontophoresis groups. The participants and assessor will be blinded for the study hypothesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Acupoint
Arm Type
Experimental
Arm Description
Laser will be performed 3 times per week for 2-week measurement. The duration of each cession will be 10 minutes treatment.
Arm Title
Tap water iontophoresis
Arm Type
Active Comparator
Arm Description
Tap water iontophoresis will be performed 3 times per week for 2-weeks. The duration of each cession will be 20 minutes treatment session.
Intervention Type
Device
Intervention Name(s)
Laser Acupoint
Intervention Description
Step 1: The subject was in sitting position and exposure area for applying laser then therapist use tap measurement to find the point. Parameters was used in this study : PROBE :ML A1\25 TIME:01:00 FREQUENCY: 10000Hz (25mw), DUTY-CYCLE:100% DENESITY: 1J\CM2 AREA :1CM2 Step 2: Apply laser on acupuncture points by using 10000HZ for 1 minute for every point. Totally cession: 10 minutes Step 3: ensure that all point done Repeat all steps for every subject
Intervention Type
Device
Intervention Name(s)
Tap water iontophoresis
Intervention Description
Enough tap water is placed in the pans, then the generator is plugged in and switched on. After that, the patient's hands are placed in the pans. The treatment is administrated by slowly increased intensity to tell the patient to feel a tingling sensation or up to 20 milliamperes and continue with this polarity for 10 minutes. After that, the polarity reversed and intensity increased again to the desired level for another 10 minutes.
Primary Outcome Measure Information:
Title
Hyperhidrosis Disease Severity Scale
Description
The Hyperhidrosis Disease Severity Scale (HDSS) is a disease-specific, quick, and easily-understood diagnostic tool that provides a qualitative measure of the severity of the patient's condition based on how it affects daily activities. Ask the patient to select the statement above that best reflects his or her experience with sweating of the specified body area. Next to each statement is a number. A score of 3 or 4 indicates severe hyperhidrosis. A score of 1 or 2 indicates mild or moderate hyperhidrosis.
Time Frame
Change between baseline and 2 weeks of treatment measures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: volunteer subjects from MIT physical therapy students complained from hyperhidrosis examined by Hyperhidrosis Disease Severity Scale, Perceived Stress Scale. Exclusion Criteria: Subjects will be excluded if they had musculoskeletal diseases and visceral disorders or had any operations or recent injury
Facility Information:
Facility Name
Kafrelshaikh University
City
Kafr Ash Shaykh
ZIP/Postal Code
12623
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Laser Acupuncture Versus Tap Water Iontophoresis on Hyperhidrosis

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