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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Post Traumatic Induced Spasticity Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Selective dorsal rhizotomy with neuromonitoring

Procedure

In prone position and Under general anaesthesia, and according to neuromonitoring, a microscopic cut of the rootlet ( of the dorsal root of spinal nerve) that supply the group that is most spastic

Primary outcomes

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Afnan Morad

CONTACT

[email protected]

01113890330

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Selective Dorsal Rhizotomy as a Cost Effective and Safe Procedure as an Alternative to Intrathecal Baclofen Pump in Patients With Post Traumatic Spasticity: Multi-center Cohort Study

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 13, 2026
Registry last updated: May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting