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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04488835

Collaborator

(none)

Enrollment

Location

Arms

19.2

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Neuralgia,Postherpetic	Other: Electromagnetic field therapy and transcutaneous electrical nerve stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 10, 2018

Actual Primary Completion Date :

Mar 20, 2019

Actual Study Completion Date :

Oct 15, 2019

Arms and Interventions

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).

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

Outcome Measures

Primary Outcome Measures

neuralgia [8 weeks]
Visual analogue scale for pain ,zero indicates no pain ten indicates maximum pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marwa Eid	Cairo		Egypt	2011

Sponsors and Collaborators

Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwa Eid, assistant professor of physical therapy for surgery, Cairo University

ClinicalTrials.gov Identifier:

NCT04488835

Other Study ID Numbers:

68mm

First Posted:

Jul 28, 2020

Last Update Posted:

Aug 13, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neuralgia

Neuralgia, Postherpetic

Study Results

No Results Posted as of Aug 13, 2020