Effect of TENS on Patients With Palmar Hyperhidrosis

Not Applicable

Terminated

• Conditions: Hyperhidrosis Primary Focal Palms
• Interventions: Device: Transcutaneous electrical nerve stimulation

• Registration Number: NCT06532045
• Lead Sponsor: Cairo University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2024-05-16
• Study Completion: 2024-05-16
• Status Verified: 2024-07
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TENS arm	Transcutaneous electrical nerve stimulation	This arm who was experimental group who received transcutaneous electrical nerve stimulation and breathing exercises
Breathing arm	Transcutaneous electrical nerve stimulation	This arm was sham and not received official treatment

Primary Outcome Measures

Name	Time	Method
Change the severity of hyperhidrosis	2 weeks	Measure the rate sweating by iodine starch testin unit of score

Secondary Outcome Measures

Name	Time	Method
Change the quality of life	2 weeks	Measure Quality of life by questionnaire in unit of grade

Trial Locations

Locations (1)

Mahmoud; 🇪🇬 Cairo, Cairo Government, Egypt