Effect of TENS on Patients With Palmar Hyperhidrosis

Effect of Transcutaneous Electrical Nerve Stimulation on Patients With Palmar Hyperhidrosis

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

Study Overview

• Status: Terminated
• Conditions: Hyperhidrosis Primary Focal Palms
• Intervention / Treatment: Device: Transcutaneous electrical nerve stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Government
    • Cairo, Cairo Government, Egypt, 3753450
      • mahmoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS arm; This arm who was experimental group who received transcutaneous electrical nerve stimulation and breathing exercises	Device: Transcutaneous 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.; Other Names: TENS
Sham Comparator: Breathing arm; This arm was sham and not received official treatment	Device: Transcutaneous 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.; Other Names: TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change the severity of hyperhidrosis	Measure the rate sweating by iodine starch testin unit of score	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change the quality of life	Measure Quality of life by questionnaire in unit of grade	2 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Amir Saleh, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): May 16, 2024
• Study Completion (Actual): May 16, 2024

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: P.T.REC/012/004611

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes