Selective dorsal rhizotomy in spinal cord injury-induced spasticity

Not Applicable

Recruiting

• Conditions: 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; S24.10

• Registration Number: IRCT20200502047277N7
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).