HyperhidrosisNCT04862546
Laser Acupuncture Versus Tap Water Iontophoresis on Hyperhidrosis
A study testing Laser Acupoint and Tap water iontophoresis in people with Hyperhidrosis, run by Kafrelsheikh University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- Laser Acupoint and Tap water iontophoresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 7 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- volunteer subjects from MIT physical therapy students complained from hyperhidrosis examined by Hyperhidrosis Disease Severity Scale, Perceived Stress Scale.
Who cannot join
- Subjects will be excluded if they had musculoskeletal diseases and visceral disorders or had any operations or recent injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Hyperhidrosis
- Being tested
- Laser Acupoint, Tap water iontophoresis
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser AcupointDevice
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 iontophoresisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Tap water iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline and 2 weeks of treatment measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Feb 2021
- Primary completion9 Jul 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Kadry, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862546
- Sponsor's protocol ID
- LaserAcupuncture
- Status last verified
- Sep 2021
- First submitted
- 23 Apr 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture Points Laser Versus Tap Water Iontophoresis on Hyperhidrosis
- ClinicalTrials.gov ID
- NCT04862546
- Acronym / sponsor ID
- LaserAcupuncture
- Conditions
- Hyperhidrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Acupoint | Experimental | Device: Laser AcupointLaser will be performed 3 times per week for 2-week measurement. The duration of each cession will be 10 minutes treatment. |
| Tap water iontophoresis | Active comparator | Device: Tap water iontophoresisTap water iontophoresis will be performed 3 times per week for 2-weeks. The duration of each cession will be 20 minutes treatment session. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- volunteer subjects from MIT physical therapy students complained from hyperhidrosis examined by Hyperhidrosis Disease Severity Scale, Perceived Stress Scale.
Key exclusion criteria (1 listed)
- Subjects will be excluded if they had musculoskeletal diseases and visceral disorders or had any operations or recent injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser AcupointStep 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 | Device | Laser Acupoint |
| Tap water iontophoresisEnough 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. | Device | Tap water iontophoresis |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hyperhidrosis
RecruitingObservational study
Targeting Nociceptors in Hidradenitis Suppurativa
Hidradenitis Suppurativa, Hyperhidrosis
Not yet recruiting
20% Alcohol With Steroid Local Anesthetic Technique Versus Steroid Local Anesthetic Technique Only in Stellate Ganglion Injection in Idiopathic Palmar Hyperhydrosis
Hyperhidrosis
Recruiting
Botulinum Toxin Type A for Frontal Hyperhidrosis
Primary Frontal Hyperhidrosis
Not yet recruitingObservational study
"Incidence of Compensatory Hyperhidrosis After T3 Vs T3-4 Sympathectomy"
Compensatory Hyperhidrosis, Compensatory Sweating
Recruiting
A Polymer Film Device to Treat Excessive Palmar Sweating
Palmar Hyperhidrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Acupoint and Tap water iontophoresis in people with Hyperhidrosis, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperhidrosis Disease Severity Scale (time frame: Change between baseline and 2 weeks of treatment measures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.