Effect of TENS on Patients With Palmar Hyperhidrosis

NCT ID: NCT06532045

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-05-16

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.

Conditions

Hyperhidrosis Primary Focal Palms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TENS arm

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

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

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.

Breathing arm

This arm was sham and not received official treatment

Group Type: SHAM_COMPARATOR

Transcutaneous electrical nerve stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

TENS

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Mohamed

Professor doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Saleh, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Mahmoud

Cairo, Cairo Government, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004611

Identifier Type: -

Identifier Source: org_study_id