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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07583277
Enrollment
32
Registered
2026-05-13
Start date
2026-06-01
Completion date
2027-06-01
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Induced Spasticity

Keywords

Selective dorsal rhizotomy, Spasticity, Post traumatic induced spasticity, Spinal cord injury, Traumatic brain injury

Brief summary

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.

Detailed 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.

Interventions

PROCEDURESelective dorsal rhizotomy with neuromonitoring

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

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

Contacts

CONTACTAfnan Morad
afnanmrad45@gmail.com01113890330

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026