Effect of Nerve Stimulation on Sciatic Nerve Injury Pediatric Patients

NCT06781060 | Recruiting DMC

• 1 other identifier: AzeemH-01/MN/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Leg Pain; Peripheral Nerve Discontinuities; Muscle Weakness; Sciatic Nerve Compression

Keywords

PISNI; FNS; ES; Peripheral Nerve Injury; Sciatic Nerve Traumatic Injury

Outcome Measures

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.

  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 (4)

• 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.

Study Arms (2)

Faradic Nerve Stimulation Intervention Group A

EXPERIMENTAL

This is an intervention group in which Standard Physiotherapy + Electrical Nerve Stimulation will be provided to the participants.

Device: Faradic Nerve Stimulation Therapy+Standard Physiotherapy

Control TENS Stimulation Group B

ACTIVE COMPARATOR

This is control group in which Standard Physiotherapy + TENS Stimulation will be provided to the participants.

Device: Physiotherapy Standard Treatment with TENS machine therapy

Interventions

Faradic Nerve Stimulation Therapy+Standard Physiotherapy DEVICE

This is electrical nerve stimulation with faradic type current to the injured nerve for conservative treatment of post injection sciatic nerve injury.

Faradic Nerve Stimulation Intervention Group A

Physiotherapy Standard Treatment with TENS machine therapy DEVICE

The control group in which Standard Physiotherapy + TENS therapy will be provided to the participants.

Control TENS Stimulation Group B

Eligibility Criteria

• Age: 3 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azeem Hospital, Multan: lead

Study Sites (1)

Azeem Hospital Mutan

Multan, Punjab Province, 60000, Pakistan

RECRUITING

MeSH Terms

Conditions

Muscle Weakness; Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Prof Dr Muhammad Zia Ul Haq Professor-Supervisor, PhD

  Lincoln University College (LUC), Malaysia

  STUDY DIRECTOR

Central Study Contacts

Chaman Lal PT, PPDPT (MPhil Physiotherapy)

CONTACT

+923333256772/+60177509748; chaman@lincoln.edu.my

Jeeya Paul Incharge Physiotherapist Rehab Center, Master in Physical Therapy(MS)

CONTACT

+923154504800; pauljeeya@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: The study outlined follows a randomized controlled trial (RCT) interventional model designed to assess the effectiveness of Faradic Nerve Stimulation (FNS) combined with standard physiotherapy in treating Post-Injection Sciatic Nerve Injury (PISNI) in pediatric patients. PISNI is a condition that typically occurs after an improper intramuscular (IM) injection, often leading to severe long-term consequences such as chronic pain, muscle weakness, and significant loss of mobility. While traditional treatment strategies, especially physiotherapy, are often used to manage PISNI, they may not always result in complete recovery. The primary aim of this study is to investigate whether the addition of FNS to standard physiotherapy could offer superior therapeutic benefits by improving nerve regeneration, alleviating pain, and enhancing functional mobility in children suffering from this injury.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 17, 2025
• Study Start: November 18, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 5, 2025
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after completion of the study and final statistical analysis. It will be available for researchers for 3 years after the completion of the study.
• Access Criteria: The approved researchers, including academic institutions, healthcare professionals, and research organizations, who have a legitimate research interest and have received ethical approval to access the data, will be able to access the IPD and supporting information. Researchers will be able to access de-identified individual participant data (IPD), including nerve conduction velocity (NCV), pain intensity scores, functional mobility assessments, and quality of life data. Access to the data and supporting information will be provided through a secure online platform. Researchers will need to submit a formal request outlining the purpose of the data use. The request will be reviewed and approved by the study's ethics committee to ensure compliance with privacy regulations and ethical guidelines. Once approved, access will be granted to the appropriate data, and researchers will be required to adhere to confidentiality agreements and data protection standards.

Locations

PA (1)