This study is a phase IV clinical trial with the objective of evaluating whether pain relief associated with pregabalin for at-level non-evoked and evoked neuropathic pain is more efficient during the early rather than late subacute phase of spinal cord injury.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
82
Pregabalin Alpha2-delta calcium channel blocker. 150mg BID p.o.
150mg BID p.o.
Hospital Nacional de Parapléjicos de Toledo
Toledo, Toledo, Spain
Daily at-level non-evoked pain intensity measured with the numerical rating scale (0-10) expressed as the mean 7-day pain intensity
Weekly below-level non-evoked pain intensity measured with the numerical rating scale (0-10)
Weekly evaluation of at-level neuropathic pain symptoms using the "Neuropathic Pain Symptoms Inventory" (NPSI)
Weekly evaluation of at-level neuropathic pain intensity and interference using the "Brief Pain Inventory" (BPI)
Weekly evaluation of the change in at-level non-evoked neuropathic pain using the "Patient Global Impression Change" (PGIC)
Weekly evaluation of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
Weekly evaluation of spasm frequency below the spinal cord injury using the Penn questionnaire
Measurement of the amplitude of cold and heat sensory evoked potentials (Cz-Fz) studied above (C4) and at-level of the SCI
Serum TNF-R1 level
Weekly at-level non-evoked pain intensity measured with the numerical rating scale (0-10) 28 days after the termination of the clinical trial
Number of Paracetamol tablets used as rescue medication during the week
Prevalence and type of adverse events in patients treated with pregabalin
Unblinding testing: patient and investigator will be asked for the treatment they think to have received. Reasons for their judgement (efficacy and safety) will also be asked.
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