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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04862546
Other study ID # LaserAcupuncture
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date September 7, 2021

Study information

Verified date September 2021
Source Kafrelsheikh University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 7, 2021
Est. primary completion date July 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 22 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Laser Acupoint
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
Tap water iontophoresis
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.

Locations

Country Name City State
Egypt Kafrelshaikh University Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change between baseline and 2 weeks of treatment measures
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