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

Assiut University

Status: Begins enrollment this month

Conditions: Post Traumatic Induced Spasticity

Treatments: Procedure: Selective dorsal rhizotomy with neuromonitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07583277

SDR

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Selective dorsal rhizotomy parm

Experimental group

Description:

This will be the enrolled group of patients that will match the eligibility criteria and give the consent to undergo the surgery

Treatment:

Procedure: Selective dorsal rhizotomy with neuromonitoring