Effect of Nerve Stimulation on Sciatic Nerve Injury Pediatric Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-19
SponsorAzeem Hospital, Multan
About this trial
Brief Summary The goal of this study is to learn if Faradic Nerve Stimulation (FNS) can help children recover from a condition called Post-Injection Sciatic Nerve Injury (PISNI). PISNI happens when the sciatic nerve, which controls muscles and sensation in the legs, gets injured from an injection that was given in the wrong place or in the wrong way. This injury can cause pain, muscle weakness, and problems moving the legs.
The main questions this study aims to answer are:
Can Faradic Nerve Stimulation help children with PISNI recover better than regular physiotherapy alone? Does FNS reduce pain and improve movement in children with this injury? What will happen in the study?
Children with PISNI will be treated in one of two groups:
Group A will receive Faradic Nerve Stimulation along with regular physiotherapy.
Group B will receive only regular physiotherapy and a similar treatment called Transcutaneous Electrical Nerve Stimulation (TENS).
Both treatments will be given by healthcare professionals in a safe and comfortable environment. Participants will be asked to attend therapy sessions for a few months and will be checked regularly to see how well they are recovering.
Why is this study important?
Post-Injection Sciatic Nerve Injury is common in children, especially in countries where healthcare providers may not be properly trained. This can lead to long-term problems, including pain and difficulty walking. Standard physiotherapy helps but doesn't always work well enough. By testing Faradic Nerve Stimulation, this study hopes to find a treatment that helps nerves heal faster and more completely, especially in children who need it most.
The findings from this study could lead to better treatments for nerve injuries in children, particularly in areas where healthcare resources are limited. If FNS works well, it could be a new way to help children recover and live pain-free lives.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients diagnosed with Post-Injection Sciatic Nerve Injury (PISNI) caused by improper intramuscular (IM) injections.
Children aged 3 to 19 years.
Parental consent for participation in the study.
Assent from the child (when applicable), depending on the age and understanding of the participant.
Disqualifiers
Children requiring surgical intervention for severe neurotmesis.
Patients with neurological or musculoskeletal conditions that may affect the outcomes (e.g., muscular dystrophy, multiple sclerosis).
Children who are unable to participate in physical therapy due to other medical conditions or severe limitations.
Children with severe systemic or other comorbid conditions that could interfere with study participation or outcome measures.
Trial design
Design model
Parallel
Treatments tested in this trial
Faradic Nerve Stimulation Therapy+Standard Physiotherapy
DeviceThis is electrical nerve stimulation with faradic type current to the injured nerve for conservative treatment of post injection sciatic nerve injury.
Physiotherapy Standard Treatment with TENS machine therapy
DeviceThe control group in which Standard Physiotherapy + TENS therapy will be provided to the participants.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Faradic Nerve Stimulation Intervention Group AExperimental treatment 1 intervention
Group B: Control TENS Stimulation Group BActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Nerve Conduction Study (NCS)
The primary outcome measure evaluates the electrophysiological recovery of the sciatic nerve in pediatric participants with Post-Injection Sciatic Nerve Injury (PISNI). This is assessed through nerve conduction velocity (NCV), latency \& amplitude, which measures the speed of electrical signals traveling through the sciatic nerve. An improvement in NCV indicates successful nerve regeneration and recovery of nerve function. The outcome will compare participants receiving Faradic Nerve Stimulation (FNS) combined with standard physiotherapy to those receiving Transcutaneous Electrical Nerve Stimulation (TENS) with standard physiotherapy.
Time frame
The primary outcome will be assessed at baseline (pre-treatment) and at the end of the 8-week and final at 16 weeks treatment phase, to monitor ongoing recovery.Secondary outcomes
1
FLACC Pediatric Pain Scale
Rates pain based on observable behaviors like facial expressions, leg movement, and crying. It provides ranked scores but without equal intervals.
Time frame
At Baseline, 8 weeks and 16 weeks2
Wong-Baker FACES Pain Scale
Subjects rate their pain using facial expressions representing varying levels of discomfort, arranged in a ranked order.
Time frame
At Baseline, 8 weeks and 16 weeks3
Pediatric Quality of Life Family Impact Module (PQL-FIM)
The primary outcome measure assesses the improvement in quality of life of pediatric participants with Post-Injection Sciatic Nerve Injury (PISNI). This will be measured using the Pediatric Quality of Life Family Impact Module (PQL-FIM), which evaluates the impact of the child's health condition on the child's quality of life as well as the well-being of their family. Improvements in scores indicate a positive change in the child's daily functioning and family well-being. The PQL-FIM tool will be used to assess the quality of life in both groups (those receiving Faradic Nerve Stimulation (FNS) with physiotherapy and those receiving Transcutaneous Electrical Nerve Stimulation (TENS) with physiotherapy).
Time frame
The primary outcome will be assessed at baseline (pre-treatment) and at the end of the 8-week and final at 16 weeks treatment phase, to monitor ongoing recovery.4
Pediatric Evaluation of Disability Inventory (PEDI)
The primary outcome measure evaluates the improvement in functional mobility in pediatric participants with Post-Injection Sciatic Nerve Injury (PISNI). This will be measured using the Pediatric Evaluation of Disability Inventory (PEDI), which assesses a child's ability to perform self-care, mobility, and social function. An improvement in functional mobility scores will indicate better recovery of physical abilities and independence. The measure will compare the outcomes between participants receiving Faradic Nerve Stimulation (FNS) combined with standard physiotherapy and those receiving Transcutaneous Electrical Nerve Stimulation (TENS) with physiotherapy.
Time frame
The primary outcome will be assessed at baseline (pre-treatment) and at the end of the 8-week and final at 16 weeks treatment phase, to monitor ongoing recovery.Sponsors and contacts
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Source ClinicalTrials.gov