Laser Acupuncture Versus Tap Water Iontophoresis on Hyperhidrosis

Effect of Acupuncture Points Laser Versus Tap Water Iontophoresis on Hyperhidrosis

the purpose of the present study is to assess the effect of laser acupoints on subjects with hyperhidrosis in comparison to tap water iontophoresis

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Device: Laser Acupoint; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt, 12623
    • Kafrelshaikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 22 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Acupoint; Laser will be performed 3 times per week for 2-week measurement. The duration of each cession will be 10 minutes treatment.	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
Active Comparator: Tap water iontophoresis; Tap water iontophoresis will be performed 3 times per week for 2-weeks. The duration of each cession will be 20 minutes treatment session.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): July 9, 2021
• Study Completion (Actual): September 7, 2021

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: LaserAcupuncture

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No