Laser Acupuncture Versus Tap Water Iontophoresis on Hyperhidrosis
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| ClinicalTrials.gov Identifier: NCT04862546 |
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Recruitment Status :
Completed
First Posted : April 28, 2021
Last Update Posted : September 16, 2021
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Sponsor:
Kafrelsheikh University
Information provided by (Responsible Party):
Ahmed Mahmoud Kadry, Kafrelsheikh University
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hyperhidrosis | Device: Laser Acupoint Device: Tap water iontophoresis | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Acupuncture Points Laser Versus Tap Water Iontophoresis on Hyperhidrosis |
| Actual Study Start Date : | February 1, 2021 |
| Actual Primary Completion Date : | July 9, 2021 |
| Actual Study Completion Date : | September 7, 2021 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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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. |
Primary Outcome Measures :
- Hyperhidrosis Disease Severity Scale [ Time Frame: Change between baseline and 2 weeks of treatment measures ]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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 22 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04862546
Locations
| Egypt | |
| Kafrelshaikh University | |
| Kafr Ash Shaykh, Egypt, 12623 | |
Sponsors and Collaborators
Kafrelsheikh University
| Responsible Party: | Ahmed Mahmoud Kadry, Lecture of Physical Therapy, Kafrelsheikh University |
| ClinicalTrials.gov Identifier: | NCT04862546 |
| Other Study ID Numbers: |
LaserAcupuncture |
| First Posted: | April 28, 2021 Key Record Dates |
| Last Update Posted: | September 16, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Hyperhidrosis Sweat Gland Diseases Skin Diseases |