Effect of Faradic Nerve Stimulation on Post-Injection Sciatic Nerve Injury Pediatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Nerve Conduction Study (NCS)
Study Overview
Brief Summary
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.
Detailed Description
Background and Clinical Significance
Post-Injection Sciatic Nerve Injury (PISNI) is an important medical concern, particularly in children who are more vulnerable to this complication due to their developing anatomy and physiology. PISNI occurs when the sciatic nerve, which is responsible for motor and sensory functions in the lower limbs, is damaged during an intramuscular (IM) injection. This injury can result from improper needle placement, improper injection techniques, or repeated injections into the same site. PISNI leads to long-term disabilities including pain, muscle weakness, impaired mobility, and permanent nerve damage if not treated adequately. The prevalence of PISNI is notably higher in low-resource settings, where healthcare providers may lack proper training or access to necessary medical tools.
In Pakistan, studies have shown that the incidence of PISNI in pediatric populations ranges between 3.38% and 9%, primarily due to unsafe injection practices. Children in rural areas are especially at risk due to the limited availability of skilled healthcare providers, contributing to the increased occurrence of nerve injuries from IM injections. The repercussions of these injuries are not only physical but also emotional and social, as children face difficulties in performing everyday tasks and experience chronic pain, which can significantly reduce their quality of life.
Current treatment options for PISNI are limited, with most therapies focusing on pain relief and symptom management rather than promoting true nerve recovery or healing. Conventional physiotherapy has shown some benefit but is not always sufficient for complete recovery, especially in severe cases. Therefore, this study seeks to investigate the effectiveness of Faradic Nerve Stimulation (FNS) in treating PISNI and improving the recovery outcomes in pediatric patients.
The Proposed Solution: Faradic Nerve Stimulation (FNS) Faradic Nerve Stimulation (FNS) is an innovative therapeutic approach that uses low-frequency electrical pulses to stimulate muscles, improve nerve conduction, and promote nerve regeneration. The technique has been widely studied in the context of adult neuromuscular rehabilitation but remains underexplored in pediatric cases, particularly for PISNI. By stimulating the sciatic nerve and the surrounding muscles, FNS aims to enhance neuromuscular recovery, improve muscle strength, and reduce pain and inflammation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Control TENS Stimulation Group B
This is control group in which Standard Physiotherapy + TENS Stimulation will be provided to the participants.
Intervention: Physiotherapy Standard Treatment with TENS machine therapy (Device)
Faradic Nerve Stimulation Intervention Group A
This is an intervention group in which Standard Physiotherapy + Electrical Nerve Stimulation will be provided to the participants.
Intervention: Faradic Nerve Stimulation Therapy+Standard Physiotherapy (Device)
Outcomes
Primary Outcomes
Nerve Conduction Study (NCS)
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.
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.
Secondary Outcomes
- FLACC Pediatric Pain Scale(At Baseline, 8 weeks and 16 weeks)
- Wong-Baker FACES Pain Scale(At Baseline, 8 weeks and 16 weeks)
- Pediatric Quality of Life Family Impact Module (PQL-FIM)(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.)
- Pediatric Evaluation of Disability Inventory (PEDI)(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.)
Investigators
Dr Chaman Lal
Physiotherapist
Azeem Hospital, Multan