Selective Dorsal Rhizotomy as a Cost Effective and Safe Procedure as a Alternative to Intrathecal Baclofen Pump in Patients With Post Traumatic Spasticity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Selective dorsal rhizotomy with neuromonitoring.
- Who it may be relevant to
- Registry conditions: Post Traumatic Induced Spasticity. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
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.
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
- Procedure Selective 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
Primary outcome measures
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- He J, Luo A, Yu J, Qian C, Liu D, Hou M, Ma Y. Quantitative assessment of spasticity: a narrative review of novel approaches and technologies. Front Neurol. 2023 Jul 5;14:1121323. doi: 10.3389/fneur.2023.1121323. eCollection 2023. PMID 37475737
- Shourijeh MS, Stampas A, Chang SH, Korupolu R, Francisco GE. Advancements in Understanding Spasticity: A Neuromusculoskeletal Modeling Perspective. J Clin Med. 2025 Nov 15;14(22):8092. doi: 10.3390/jcm14228092. PMID 41303128
- Lindsay C, Simpson J, Ispoglou S, Sturman SG, Pandyan AD. The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial. Trials. 2014 Jan 8;15:12. doi: 10.1186/1745-6215-15-12. PMID 24401159
- Ertzgaard P, Campo C, Calabrese A. Efficacy and safety of oral baclofen in the management of spasticity: A rationale for intrathecal baclofen. J Rehabil Med. 2017 Mar 6;49(3):193-203. doi: 10.2340/16501977-2211. PMID 28233010
- Enslin JMN, Langerak NG, Fieggen AG. The Evolution of Selective Dorsal Rhizotomy for the Management of Spasticity. Neurotherapeutics. 2019 Jan;16(1):3-8. doi: 10.1007/s13311-018-00690-4. PMID 30460456
Identifiers
NCT: NCT07583277 · SDR