Pulsed Electromagnetic Field Therapy Versus Transcutaneous Electrical Nerve Stimulation in on Post-herpetic Neuralgia of the Sciatic Nerve

August 11, 2020 updated by: Marwa Eid, Cairo University

A Comparative Study Between Pulsed Electromagnetic Field Therapy and Transcutaneous Electrical Nerve Stimulation in Management of Post-herpetic Neuralgia of the Sciatic Nerve

Background and purpose: Post-herpetic neuralgia (PHN) is the most frequent chronic complication of herpes zoster, resulting in post- infectious severe neuropathic pain. Due to drug resistance severe pain; patients with PHN suffer from reduced physical activities, social and psychological manifestations as well as decrease in the quality of life. The purpose of this research was to evaluate the efficacy of pulsed electromagnetic field therapy (PEMFT) versus transcutaneous electrical nerve stimulation (TENS) in the treatment of post-herpetic neuralgia of the sciatic nerve.

Methods: In an eight weeks period of treatemnt, 52 patients were randomly and equally assigned into two groups. Both groups received conventional physical therapy treatment protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes for each session. Assessment performed pre and post intervention using visual analogue scale (VAS) and estimation of the carbamazepine intake (CMI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 2011
        • Marwa Eid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age from 30-40 years
  • History of herpes zoster more than 90 days
  • Visual analogue scale is greater than or equal 5 out on a scale from 0 to 10
  • All patients were on pain medication "Carbamazepine"

Exclusion Criteria:

  • uncooperative behavior
  • Intellectual disability to complete the self-evaluation questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS Therapy Group
patients in this group received TENS therapy in addition to routine physical therapy
Other: Electromagnetic field therapy and transcutaneous electrical nerve stimulation
Both groups received conventional physical therapy treatment protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes for each session. Assessment performed pre and post intervention using visual analogue scale (VAS) and estimation of the carbamazepine intake (CMI).
Experimental: PEMFT group
patients in this group received PEMFT therapy in addition to routine physical therapy
Other: Electromagnetic field therapy and transcutaneous electrical nerve stimulation
Both groups received conventional physical therapy treatment protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes for each session. Assessment performed pre and post intervention using visual analogue scale (VAS) and estimation of the carbamazepine intake (CMI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuralgia
Time Frame: 8 weeks
Visual analogue scale for pain ,zero indicates no pain ten indicates maximum pain
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Marwa Eid, Ass.prof., Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2018

Primary Completion (Actual)

March 20, 2019

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 24, 2020

First Posted (Actual)

July 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68mm

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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