ArticleJMIR research protocols2025
Pulmonary Function and Sleep-Related Disorders During Cervical Administration of Intrathecal Baclofen in Adults With Spinal Cord Injury (Cervit-B): Protocol for a Multiphase Single-Arm Intervention Trial.
Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe effect and safety of intrathecal baclofen (ITB) on generalized spasticity of the lower extremity have been well described in numerous studies, whereas the safety and effect on spasticity of the upper extremity during cervical administration seems to be less certain.
objectiveWe aim to establish the safety of cervical administration of ITB on pulmonary function and sleep-related disorders in adults with a cervical spinal cord injury with functional hindering spasticity. In addition, we aim to explore the effect of cervical ITB on the reduction of spasticity; participant satisfaction; and improvement at the level of function, activities, and participation.
methodsThe study is a multiphase single-arm intervention study. Before the start of the study, participants are screened for the presence of sleep-related disorders, and pulmonary function is assessed using spirometry and a capillary blood gas sample. Participants are allowed to start the first phase of the study if there are no signs of sleep-related disorders or if these are adequately treated. The P
resultsThe first participant was recruited on May 23, 2023. Data collection and analyses are expected to be completed in 2027.
conclusionsCurrently, little is known about the safety and effectiveness of cervical administration of ITB for the treatment of upper extremity spasticity. We aim to establish the safety and explore the efficacy of this procedure. This paper describes the protocol of this study. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/70362.
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