NCT04488835

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

1 year

First QC Date

July 22, 2020

Last Update Submit

August 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • neuralgia

    Visual analogue scale for pain ,zero indicates no pain ten indicates maximum pain

    8 weeks

Study Arms (2)

TENS Therapy Group

EXPERIMENTAL

patients in this group received TENS therapy in addition to routine physical therapy

Other: Electromagnetic field therapy and transcutaneous electrical nerve stimulation

PEMFT group

EXPERIMENTAL

patients in this group received PEMFT therapy in addition to routine physical therapy

Other: Electromagnetic field therapy and transcutaneous electrical nerve stimulation

Interventions

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).

PEMFT groupTENS Therapy Group

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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"

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Marwa Eid, Ass.prof.

    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
assistant professor of physical therapy for surgery

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 28, 2020

Study Start

March 10, 2018

Primary Completion

March 20, 2019

Study Completion

October 15, 2019

Last Updated

August 13, 2020

Record last verified: 2020-08

Locations