Back to resultsPulsed Electromagnetic Field Therapy Versus Transcutaneous Electrical Nerve Stimulation in on Post-herpetic Neuralgia of the Sciatic Nerve
Primary Purpose
Neuralgia,Postherpetic
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Electromagnetic field therapy and transcutaneous electrical nerve stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia,Postherpetic
Eligibility Criteria
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
Sites / Locations
- Marwa Eid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TENS Therapy Group
PEMFT group
Arm Description
patients in this group received TENS therapy in addition to routine physical therapy
patients in this group received PEMFT therapy in addition to routine physical therapy
Outcomes
Primary Outcome Measures
neuralgia
Visual analogue scale for pain ,zero indicates no pain ten indicates maximum pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04488835
Brief Title
Pulsed Electromagnetic Field Therapy Versus Transcutaneous Electrical Nerve Stimulation in on Post-herpetic Neuralgia of the Sciatic Nerve
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2018 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia,Postherpetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS Therapy Group
Arm Type
Experimental
Arm Description
patients in this group received TENS therapy in addition to routine physical therapy
Arm Title
PEMFT group
Arm Type
Experimental
Arm Description
patients in this group received PEMFT therapy in addition to routine physical therapy
Intervention Type
Other
Intervention Name(s)
Electromagnetic field therapy and transcutaneous electrical nerve stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
neuralgia
Description
Visual analogue scale for pain ,zero indicates no pain ten indicates maximum pain
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Eid, Ass.prof.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marwa Eid
City
Cairo
ZIP/Postal Code
2011
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Pulsed Electromagnetic Field Therapy Versus Transcutaneous Electrical Nerve Stimulation in on Post-herpetic Neuralgia of the Sciatic Nerve
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