Neuralgia,PostherpeticNCT04488835
Pulsed Electromagnetic Field Therapy Versus Transcutaneous Electrical Nerve Stimulation in on Post-herpetic Neuralgia of the Sciatic Nerve
A study testing Electromagnetic field therapy and transcutaneous electrical nerve stimulation in people with Neuralgia,Postherpetic, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Neuralgia,Postherpetic
- What is being tested?
- Electromagnetic field therapy and transcutaneous electrical nerve stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2018to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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"
Who cannot join
- uncooperative behavior
- Intellectual disability to complete the self-evaluation questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Neuralgia,Postherpetic
- Being tested
- Electromagnetic field therapy and transcutaneous electrical nerve stimulation
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromagnetic field therapy and transcutaneous electrical nerve stimulationOther
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 group | Role | What they receive |
|---|---|---|
| TENS Therapy Group | Experimental | patients in this group received TENS therapy in addition to routine physical therapy Receives: 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 Receives: Other: Electromagnetic field therapy and transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuralgia
Visual analogue scale for pain ,zero indicates no pain ten indicates maximum pain
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start10 Mar 2018
- Primary completion20 Mar 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuralgia,PostherpeticStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Eid, Cairo University
- Investigators
- Marwa Eid, Ass.prof., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488835
- Sponsor's protocol ID
- 68mm
- Status last verified
- Aug 2020
- First submitted
- 22 Jul 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04488835
- Acronym / sponsor ID
- 68mm
- Conditions
- Neuralgia,Postherpetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS Therapy Group | Experimental | Other: Electromagnetic field therapy and transcutaneous electrical nerve stimulationpatients in this group received TENS therapy in addition to routine physical therapy |
| PEMFT group | Experimental | Other: Electromagnetic field therapy and transcutaneous electrical nerve stimulationpatients in this group received PEMFT therapy in addition to routine physical therapy |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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"
Key exclusion criteria (2 listed)
- uncooperative behavior
- Intellectual disability to complete the self-evaluation questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electromagnetic field therapy and transcutaneous electrical nerve stimulationBoth 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). | Other | PEMFT group, TENS Therapy Group |
Primary outcome
neuralgia
Time frame: 8 weeks
Visual analogue scale for pain ,zero indicates no pain ten indicates maximum pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Eid, Ass.prof. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromagnetic field therapy and transcutaneous electrical nerve stimulation in people with Neuralgia,Postherpetic, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuralgia (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020; AzTrials last refreshed its copy on 1 Nov 2026.