Selective Dorsal Rhizotomy as a Cost Effective and Safe Procedure as a Alternative to Intrathecal Baclofen Pump in Patients With Post Traumatic Spasticity

N/ANot Yet RecruitingNCT07583277

Assiut University32 enrolled

Overview

The investigators will investigate the selective dorsal rhizotomy in post traumatic brain and spinal cord injury induced spasticity to evaluate the efficacy of this procedure in reducing the tone of the spastic muscle groups. Selective dorsal rhizotomy is well established effective procedure in participants with cerebral palsy associated spasticity. As low and middle income countries, intrathecal baclofen pump is expensive for patients.

Spasticity is a condition that represents a form of disability and it's associated in various conditions. Intrathecal baclofen pump is tried and has a good outcome in treatment spasticity. However, it has some aide effects and complications and also expensive. Selective dorsal rhizotomy is a surgical procedure that represents an optional treatment for spasticity and established with cerebral palsy and hereditary spasticity. Selective dorsal rhizotomy in participants with Post traumatic induced spasticity isn't established yet and not compared with the results of intrathecal baclofen. SDR is a procedure applied under general anesthesia and with neuromonitoring.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post Traumatic Induced Spasticity

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who are four year-old and above of both sexes. * Patient with post traumatic head and / or spinal injury-induced spasticity. * Ambulant and non-ambulant patient. Exclusion Criteria: * Patient below age of four year. * Other conditions induced- spasticity e.g. Strokes, CP, MS, Hereditary spastic paresis, ALS, tumors, infections and degenerative diseases. * Patient underwent previous intrathecal baclofen pump administration.

Outcomes

Primary Outcomes

Change in spasticity severity assessed by the Modified Ashworth Scale (MAS) and electromyography (EMG) amplitude

The primary outcome will be the reduction in spasticity, quantified by the change in MAS scores and EMG muscle activity measurements from baseline to post-intervention. The MAS score, ranged from 0 to 4 as 0 represents no increase in muscle tone and 4 indicates rigid limb flexion/extension, will be reported as the mean change in points, and EMG data will be summarized using the mean and standard deviation of muscle activity amplitude during standardized stretch protocols. The data will be analyzed to determine the statistical significance of improvements following the selective dorsal rhizotomy procedure

Time frame: From one week to six months post operative.