Effect of TENS on Patients With Palmar Hyperhidrosis

NCT06532045 | Terminated DMC FDA Device

• 1 other identifier: P.T.REC/012/004611
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperhidrosis Primary Focal Palms

Outcome Measures

Primary Outcomes (1)

• Change the severity of hyperhidrosis

  Measure the rate sweating by iodine starch testin unit of score

  2 weeks

Secondary Outcomes (1)

• Change the quality of life

  2 weeks

Study Arms (2)

TENS arm

EXPERIMENTAL

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

Device: Transcutaneous electrical nerve stimulation

Breathing arm

SHAM COMPARATOR

This arm was sham and not received official treatment

Device: Transcutaneous electrical nerve stimulation

Interventions

Transcutaneous electrical nerve stimulation 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.

Also known as: TENS

Breathing arm; TENS arm

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mahmoud

Cairo, Cairo Government, 3753450, Egypt

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Amir Saleh, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor doctor

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 1, 2024
• Study Start: July 1, 2023
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

EG (1)