Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP). Preliminary Study.
Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
Summary
Hypothesis:
ITB bolus can have antinociceptive effect on neuropathic pain in spinal cord injury patients,
which could depend on the subtype of pain, or on the lesion level, cervical or thoracic
spinal cord injury.
Objective:
To study the effect of intrathecal baclofen bolus on neuropathic pain in patients with spinal
cord injury at cervico-dorsal level.
Primary Endpoint:
Effect of intrathecal baclofen bolus in neuropathic pain (measured using the Neuropathic Pain
Inventory Scale, the Brief Pain Inventory and the Numerical Rating Scale) in spinal cord
injury at cervico-dorsal level.
Secondary Endpoints:
1. Spasticity and spasms (measured using the Modified Ashworth Scale and the Visual
Analogue Scale and Penn Spasm Frequency Scale).
2. Neurophysiological examination (warm perception threshold, heat pain perception
threshold, evoked pain perception and contact heat evoked potentials).