NCT04862546

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

April 23, 2021

Last Update Submit

September 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Laser Acupoint

EXPERIMENTAL

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

Tap water iontophoresis

ACTIVE COMPARATOR

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

Interventions

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

Laser Acupoint

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.

Tap water iontophoresis

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelshaikh University

Kafr ash Shaykh, 12623, Egypt

Location

MeSH Terms

Conditions

Hyperhidrosis

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecture of Physical Therapy

Study Record Dates

First Submitted

April 23, 2021

First Posted

April 28, 2021

Study Start

February 1, 2021

Primary Completion

July 9, 2021

Study Completion

September 7, 2021

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations