Effect of Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP) in Spinal Cord Injury (SCI) Patients. Preliminary Study.

NCT02705950 NA COMPLETED

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).

Details

Lead sponsor	Institut Guttmann
Phase	NA
Status	COMPLETED
Enrolment	12
Start date	2014-12
Completion	2017-08

Conditions

• Neuropathic Pain

Interventions

• Intrathecal baclofen bolus
• Placebo

Primary outcomes

• Neuropathic Pain Inventory Scale (NPIS) — Change from baseline in neuropathic pain at 4hours
  a self-questionnaire specifically designed to evaluate the different symptoms of neuropathic pain and includes 10 descriptors that allow discrimination and quantification of five distinct clinically relevant dimensions of neuropathic pain syndromes and that are sensitive to treatment

Countries

Spain