Clinical trial NCT06532045: Effect of TENS on Patients With Palmar Hyperhidrosis
Official title: Effect of Transcutaneous Electrical Nerve Stimulation on Patients With Palmar Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hyperhidrosis Primary Focal Palms
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* • Age range from 18 to 30 years old.

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

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.

Primary outcomes:
measure: Change the severity of hyperhidrosis
timeFrame: 2 weeks
Secondary outcomes:
measure: Change the quality of life
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mahmoud
state: Cairo Government
Study officials:
affiliation: Cairo University
name: Amir Saleh, Professor
role: PRINCIPAL_INVESTIGATOR
References: