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TerminatedNCT06532045Updated Aug 1, 2024

Effect of TENS on Patients With Palmar Hyperhidrosis

An interventional study of Transcutaneous electrical nerve stimulation in Hyperhidrosis Primary Focal Palms, sponsored by Cairo University. Terminated at 1 site in Egypt. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Why this study was terminated
Boring and feared

From the registry’s dates

  • Primary completion was May 2024, 2 years 5 months ago, and no results have been posted to the registry.
  • Registered 1 year after the study started (first participant enrolled Jul 2023, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

To investigate the effectiveness of Transcutaneous Electrical Nerve Stimulation on Hyperhidrosis Severity on patients with primary Palmar Hyperhidrosis.

Read the detailed description

Hyperhidrosis might be a primary condition or secondary condition due to medications or systemic disorders. Primary hyperhidrosis is usually focal,bilateral, and symmetric. It mainly affects the axillae, palms, soles, face, and scalp. The incidence of primary hyperhidrosis has been reported to be between 0.6%\~2.8% in both genders. Symptoms usually begin in childhood or around puberty. It interferes with daily social and occupational activities of patients and significantly impacts their quality of life.

Various treatments have been proposed to control primary hyperhidrosis. The treatment options for hyperhidrosis include topical therapy, anticholinergic, iontophoresis, botulinum toxin and surgery.

In addition to these treatment options for hyperhidrosis, several medical devices delivering energy to destroy sweat glands are undergoing promising clinical investigation. Microwave technology, several lasers (such as 1,064-nm, 1,320-nm, and 1,440-nm neodymium: yttrium- aluminum-garnet laser, 924-nm and 975-nm diode laser, long-pulsed 800- nm diode laser), micro needle radio frequency, and ultrasound technology could be included as example of the device.

In spite of these treatment options, the best therapeutic choice is still undefined. This concept encourages us to investigate the effectiveness of recent technique in the current research.

Up till now, the available literatures show a gap in knowledge and lack of well-designed studies. We will concern on the effect of Transcutaneous Electrical Nerve Stimulation on Hyperhidrosis Severity on patients with primary Palmar Hyperhidrosis.

02

Conditions studied

  • Hyperhidrosis Primary Focal Palms

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03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's enrollment of 56 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Age range from 18 to 30 years old.

      • Patients will be from both sexes.
      • from 18.5 to 24.9
      • Subject suffer from primary palmar hyperhidrosis.
      • No clinical treatment for palmar hyperhidrosis within the past month.

Exclusion criteria

Exclusion Criteria:

    • Patients outside the target range.

      • Patients who were pregnant or lactating.
      • Patients who had metal implants such as a pacemaker.
      • Patients who had history of ischemic heart disease or arrhythmias.
      • Patients who had any other diseases that could be the cause ofsecondary hyperhidrosis.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    TENS arm

    This arm who was experimental group who received transcutaneous electrical nerve stimulation and breathing exercises

    Device: Transcutaneous electrical nerve stimulation

  • Sham comparator
    Breathing arm

    This arm was sham and not received official treatment

    Device: Transcutaneous electrical nerve stimulation

Interventions

  • DeviceTranscutaneous electrical nerve stimulation

    TENS applied for 30 min for each time, five times a week, for 2 weeks and deep breathing relaxation exercise given to the intervention group twice a day (10min/exercise) for two weeks.

    Also known as: TENS

06

What researchers measure

Primary outcomes

  1. Change the severity of hyperhidrosis

    Measure the rate sweating by iodine starch testin unit of score

    Time frame: 2 weeks

Secondary outcomes

  1. Change the quality of life

    Measure Quality of life by questionnaire in unit of grade

    Time frame: 2 weeks

07

Study locations

1 site
  • Mahmoud
    Cairo, Cairo Government 3753450, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2023 to primary completion in May 2024, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2024
First posted
Aug 1, 2024
StartActual
Jul 1, 2023
Primary completionActual
May 16, 2024
CompletionActual
May 16, 2024
Last update
Aug 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06532045
Lead sponsor
Cairo University
Responsible party
Mahmoud Mohamed (Professor doctor, Cairo University) — Principal investigator
First posted
Aug 1, 2024
Start date
Jul 1, 2023
Primary completion
May 16, 2024
Completion
May 16, 2024
Last update
Aug 1, 2024

Study contacts

Amir Saleh, Professor
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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