Condition 1: Injury of nerves and spinal cord at neck level. Condition 2: Unspecified injury of thoracic spinal cord. Injury of nerves and spinal cord at neck level Unspecified injury of thoracic spinal cord
Conditions
Interventions
Intervention group: All patients in this study will undergo selective dorsal rhizotomy (SDR). The procedure includes partial section and division of dorsal nerve roots selected using intraoperative ne
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Modified Ashworth scale (MAS) of at least 3 and spasm frequency score (SFS) of at least 2 Patients with intractable spasticity after at least 6 months therapy with oral antispasmodic agents Candidates for intrathecal baclofen infusion who could not receive this therapy Age greater than 18 years Complete spinal cord injury or American Spinal Injury Association impairment scale (AIS) grade A Written informed consent obtained from the patient
Exclusion criteria
Exclusion criteria: Any brain lesion in areas involved in coordination or posture, such as basal ganglia or cerebellum based on MR imaging Any form of movement disorders, such as dyskinesia, dystonia, or ataxia Concurrent traumatic brain injury Genetic etiology for spasticity, such as hereditary spastic paraplegia Any evidence of a progressive neurological disorder Treatment with oral antispasmodic agents for less than six months Prior therapy with intrathecal baclofen pump Pregnancy or lactation Participation in another study during the present study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile of the study intervention. Timepoint: Baseline, 1-week, 3- and 6-month postoperatively. Method of measurement: Monitoring and evaluating the patients regarding the adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Ashworth scale (MAS). Timepoint: Baseline, 1-week, 3- and 6-month postoperatively. Method of measurement: Physical examination and using the 6-point scale.;Spasm frequency scale (SFS). Timepoint: Baseline, 1-week, 3- and 6-month postoperatively. Method of measurement: A self-report 5-point measure.;Spinal cord injury spasticity evaluation tool (SCI-SET). Timepoint: Baseline and 6-month postoperatively. Method of measurement: Self-report questionnaire including 35 items.;Visual analog scale (VAS) for spasticity. Timepoint: Baseline, 1-week, 3- and 6-month postoperatively. Method of measurement: 100 mm visual analog scale.;Spinal cord independence measure (SCIM). Timepoint: Baseline and 6-month postoperatively. Method of measurement: Scoring using the measure based on clinical observation.;Short Form 36 Health Survey Questionnaire (SF-36). Timepoint: Baseline and 6-month postoperatively. Method of measurement: Short Form 36 Health Survey Questionnaire (SF-36). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRoozbeh Tavanaei
Shahid Beheshti University of Medical Sciences
Outcome results
None listed