Neuromuscular Electrical Stimulation Versus Low-intensity Laser on Motor Conduction Velocity of the Common Peroneal Nerve Post Burn

NCT06478914 | Completed DMC

• 1 other identifier: basma PHD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Purposes of this study were the following:

1. 1.To evaluate the therapeutic efficacy of NMES in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
2. 2.To evaluate the therapeutic efficacy of LIL in improving the motor conduction velocity (MCV) of the neuropathic common peroneal nerve post burn.
3. 3.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.

Conditions

Neuropathy, Peroneal; Motor Neuropathy; Neuromuscular Electric Stimulation (NEMS); Low Intensity Laser

Outcome Measures

Primary Outcomes (1)

• 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.

  at base line and following 8 weeks

Study Arms (2)

NEMS group (group A)

EXPERIMENTAL

the first experimental group consisted of 30 patients, to which neuromuscular electric stimulation (NMES) was applied

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

Device: low-intensity laser therapy (LILT)

Interventions

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.

NEMS group (group A)

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.

LIL group (group B)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

out-clinics of Kasr-El-Aini

Cairo, Egypt

Location

MeSH Terms

Conditions

Peroneal Neuropathies; Neuritis

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind blinded randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Basma Rabie Ahmed

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: June 27, 2024
• Study Start: February 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: January 1, 2023
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)