Neuropathy, PeronealNCT06478914
Neuromuscular Electrical Stimulation Versus Low-intensity Laser on Motor Conduction Velocity of the Common Peroneal Nerve Post Burn
A study testing Neuromuscular electrical stimulation (NMES) and low-intensity laser therapy (LILT) in people with Neuropathy, Peroneal and Motor Neuropathy, run by Cairo University at 1 site in Egypt.
Trial summary
Purposes of this study were the following: 1. To evaluate the therapeutic efficacy of NMES in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn. 2. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Neuropathy, Peroneal, Motor Neuropathy, Neuromuscular Electric Stimulation (NEMS)
- What is being tested?
- Neuromuscular electrical stimulation (NMES) and low-intensity laser therapy (LILT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 1 Jan 2023
- 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients were chosen after a routine medical examination by specialist.
- All patients were approximately of the same age (from 20 to 35 years old).
- All patients were conscious.
- All of them were non-smokers and they will be under own prescribed medications described by their physicians.
- They received another physical therapy electromodality except NMES and LIL as well as the traditional physical therapy in the form of 5 minutes of deep stroking (Effleurage) maneuver for the affected lower limb before the beginning of the MCV recording to eliminate the temperature-related variability
Who cannot join
- Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases will be excluded from the study.
- Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases will be excluded from the study.
- Pregnant patients or who presented with active malignancy will be excluded from the study.
- Patients who suffer from hyperthyroidism, haemorrhage, acute viral diseases, acute tuberculosis, mental disorders or those with pace makers will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neuromuscular Electrical Stimulation Versus Low-intensity Laser in Relation to Motor Conduction Velocity of the Neuropathic Common Peroneal Nerve Post Burn
Purposes of this study were the following:
- To evaluate the therapeutic efficacy of NMES in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
- To evaluate the therapeutic efficacy of LIL in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
- To detect which one of both was the better and most effective than the other in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
Read the detailed description
Burned patients experience various problems, including skin damage, vascular damage, and metabolic stress. These injuries can lead to peripheral neuropathies, which can affect nerve function and cause weakness or lack of sensation. Lymphatic damage can delay wound healing, causing contractures that affect the patient's physical function. Burn-Associated polyneuropathy (BAPN) is common after thermal injury, affecting nerve function. Electrophysiological assessments of muscle and nerves are essential in neurology, physical therapy, and related clinical disciplines. Neuromuscular electrical stimulation (NMES) is used to increase force output, strengthen muscles, and control pain. Low-intensity laser therapy (LILT) is used to treat chronic inflammatory and fibrotic conditions, improving absorption of fluid, secretion of macrophage growth factors, DNA synthesis, pain reduction, and electron respiratory chain reaction. However, the effect of LILT on scar formation and treatment of fibrosis or calcification secondary to hematomas or fat necrosis is not yet evaluated.
The need for this study developed from the lack of quantitative knowledge and information in the published studies about the application of both NMES and LIL to improve the neuropathic common peroneal nerve postburn.
The significance of this study arises from the rarity of information about the effectiveness of both NMES and LIL on the neuropathic common peroneal nerve post-burn, as well as the precise dosage and frequency of treatment required to promote improvement of the neuropathic common peroneal nerve post burn.
- Conditions
- Neuropathy, Peroneal, Motor Neuropathy, Neuromuscular Electric Stimulation (NEMS), Low Intensity Laser
- Being tested
- Neuromuscular electrical stimulation (NMES), low-intensity laser therapy (LILT)
- Medical subject headings
- Peroneal Neuropathies, Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation (NMES)Device
NMES unit manufactured by Enraf-Holland was be used to administer the neuromuscular electrical stimulation (NMES) The study involved adjusting the patient's hips, knees, and ankles to achieve a comfortable position. Two electrodes of NMES were used in the first study group and a placebo in the control group. The electrodes were placed on the popliteal fossa and fibular head, and each session was conducted for 15 minutes daily for 2 months.
low-intensity laser therapy (LILT)Device
The laser unit is a small, hand-held, class III laser product manufactured by Laserex Technology Pty Ltd Australia. It offers continuous and pulsed laser therapy, with continuous therapy being the most effective. The device has a maximum average power of 5 milliwatts, a wavelength of 820 nm, and a power density of 0.39 W/cm2.
Patients were treated as outpatients, receiving full explanations about the purpose, therapeutic, and physiological benefits of low-intensity laser therapy (LILT). They were relaxed in supine position, with hips and knees adjusted. The patient was irradiated in a continuous mode and direct contact method, 3 times per week for 2 months, at 1-cm intervals and across the surface in grids. The laser applicator was applied to the surface, maintaining contact for maximum penetration.
| Study group | Role | What they receive |
|---|---|---|
| NEMS group (group A) | Experimental | the first experimental group consisted of 30 patients, to which neuromuscular electric stimulation (NMES) was applied Receives: Device: Neuromuscular electrical stimulation (NMES) |
| LIL group (group B) | Experimental | The second experimental group consisted of 30 patients to which the low intensity laser (LIL) was applied Receives: Device: low-intensity laser therapy (LILT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
motor conduction velocity (MCV)
The study involved a common peroneal nerve MCV measurement in an air-conditioned room. The subject was placed in a supine position for 5 minutes to rest and relax. The recording electrodes were placed over the EDB muscle, with the active electrode placed over the main bulk of the muscle. The stimulating electrodes were placed 8 cm proximal to the active electrode for distal latency and distally in the lateral part of the popliteal fossa for proximal latency. The subject was then asked to lie supine for 5 minutes for leg massage, rest, and relaxation. The EMG12 program disk was loaded, and electrodes were connected to the active channels and common electrode. The program was moved to the ready condition after pressing keys on the keyboard. The sensitivity was 1 mv/diameter, the sweep speed was 3 ms, and the stimulus intensity ranged from 0.1 to 99 mA. Segmental distances between stimulation points were measured using a tape measure.
Measured: at base line and following 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Feb 2022
- Primary completion1 Jul 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathy, PeronealStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Rabie Ahmed Fadel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478914
- Sponsor's protocol ID
- basma PHD
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Electrical Stimulation Versus Low-intensity Laser in Relation to Motor Conduction Velocity of the Neuropathic Common Peroneal Nerve Post Burn
- ClinicalTrials.gov ID
- NCT06478914
- Acronym / sponsor ID
- basma PHD
- Conditions
- Neuropathy, Peroneal, Motor Neuropathy, Neuromuscular Electric Stimulation (NEMS), Low Intensity Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 27 Jun 2024 (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.
Purposes of this study were the following:
- To evaluate the therapeutic efficacy of NMES in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
- To evaluate the therapeutic efficacy of LIL in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
- To detect which one of both was the better and most effective than the other in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
Detailed description
Burned patients experience various problems, including skin damage, vascular damage, and metabolic stress. These injuries can lead to peripheral neuropathies, which can affect nerve function and cause weakness or lack of sensation. Lymphatic damage can delay wound healing, causing contractures that affect the patient's physical function. Burn-Associated polyneuropathy (BAPN) is common after thermal injury, affecting nerve function. Electrophysiological assessments of muscle and nerves are essential in neurology, physical therapy, and related clinical disciplines. Neuromuscular electrical stimulation (NMES) is used to increase force output, strengthen muscles, and control pain. Low-intensity laser therapy (LILT) is used to treat chronic inflammatory and fibrotic conditions, improving absorption of fluid, secretion of macrophage growth factors, DNA synthesis, pain reduction, and electron respiratory chain reaction. However, the effect of LILT on scar formation and treatment of fibrosis or calcification secondary to hematomas or fat necrosis is not yet evaluated.
The need for this study developed from the lack of quantitative knowledge and information in the published studies about the application of both NMES and LIL to improve the neuropathic common peroneal nerve postburn.
The significance of this study arises from the rarity of information about the effectiveness of both NMES and LIL on the neuropathic common peroneal nerve post-burn, as well as the precise dosage and frequency of treatment required to promote improvement of the neuropathic common peroneal nerve post burn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEMS group (group A) | Experimental | Device: Neuromuscular electrical stimulation (NMES)the first experimental group consisted of 30 patients, to which neuromuscular electric stimulation (NMES) was applied |
| LIL group (group B) | Experimental | Device: low-intensity laser therapy (LILT)The second experimental group consisted of 30 patients to which the low intensity laser (LIL) was applied |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients were chosen after a routine medical examination by specialist.
- All patients were approximately of the same age (from 20 to 35 years old).
- All patients were conscious.
- All of them were non-smokers and they will be under own prescribed medications described by their physicians.
- They received another physical therapy electromodality except NMES and LIL as well as the traditional physical therapy in the form of 5 minutes of deep stroking (Effleurage) maneuver for the affected lower limb before the beginning of the MCV recording to eliminate the temperature-related variability
Key exclusion criteria (4 listed)
- Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases will be excluded from the study.
- Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases will be excluded from the study.
- Pregnant patients or who presented with active malignancy will be excluded from the study.
- Patients who suffer from hyperthyroidism, haemorrhage, acute viral diseases, acute tuberculosis, mental disorders or those with pace makers will be excluded from the study
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 |
|---|---|---|
| Neuromuscular electrical stimulation (NMES)NMES unit manufactured by Enraf-Holland was be used to administer the neuromuscular electrical stimulation (NMES) The study involved adjusting the patient's hips, knees, and ankles to achieve a comfortable position. Two electrodes of NMES were used in the first study group and a placebo in the control group. The electrodes were placed on the popliteal fossa and fibular head, and each session was conducted for 15 minutes daily for 2 months. | Device | NEMS group (group A) |
| low-intensity laser therapy (LILT)The laser unit is a small, hand-held, class III laser product manufactured by Laserex Technology Pty Ltd Australia. It offers continuous and pulsed laser therapy, with continuous therapy being the most effective. The device has a maximum average power of 5 milliwatts, a wavelength of 820 nm, and a power density of 0.39 W/cm2. Patients were treated as outpatients, receiving full explanations about the purpose, therapeutic, and physiological benefits of low-intensity laser therapy (LILT). They were relaxed in supine position, with hips and knees adjusted. The patient was irradiated in a continuous mode and direct contact method, 3 times per week for 2 months, at 1-cm intervals and across the surface in grids. The laser applicator was applied to the surface, maintaining contact for maximum penetration. | Device | LIL group (group B) |
Primary outcome
motor conduction velocity (MCV)
Time frame: at base line and following 8 weeks
The study involved a common peroneal nerve MCV measurement in an air-conditioned room. The subject was placed in a supine position for 5 minutes to rest and relax. The recording electrodes were placed over the EDB muscle, with the active electrode placed over the main bulk of the muscle. The stimulating electrodes were placed 8 cm proximal to the active electrode for distal latency and distally in the lateral part of the popliteal fossa for proximal latency. The subject was then asked to lie supine for 5 minutes for leg massage, rest, and relaxation. The EMG12 program disk was loaded, and electrodes were connected to the active channels and common electrode. The program was moved to the ready condition after pressing keys on the keyboard. The sensitivity was 1 mv/diameter, the sweep speed was 3 ms, and the stimulus intensity ranged from 0.1 to 99 mA. Segmental distances between stimulation points were measured using a tape measure.
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 27 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Neuropathy, Peroneal
Not yet recruitingObservational study
Muscle MRI Fat Fraction Before Surgery to Predict Strength Recovery After Foot-Drop Surgery in Charcot-Marie-Tooth Disease
Foot Drop, Charcot-Marie-Tooth Disease Type 1A
Recruiting
Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop
Falls, Foot Drop
Active, not recruitingObservational study
Geko™ Cross Therapy Registry - Wound
Wound, Venous Leg Ulcer
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
Recruiting
ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
Cerebrovascular Stroke, Foot Drop
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation (NMES) and low-intensity laser therapy (LILT) in people with Neuropathy, Peroneal and Motor Neuropathy, 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 5 inclusion and 4 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 27 Jun 2024. 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?
motor conduction velocity (MCV) (time frame: at base line and following 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 27 Jun 2024.