Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP). Preliminary Study.

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Guttmann
• Collaborator: Medtronic
• Treatments: Baclofen

Criteria

Inclusion Criteria:

• Age between 18-70 years and at least one year since the spinal cord injury.

• Aetiology: stable SCI from traumatic or medical origin.

• Patients with chronic refractory neuropathic pain and with spinal cord injury, both complete and incomplete, at the cervico-thoracic level.

• Severity of pain equal or greater than 4 in the Numerical Rating Scale.

• With spasticity (MAS>=).

• Stable analgesic, antispastic and any other medication.

Exclusion Criteria:

• Patients who do not give patient inform consent.

• Contraindication for baclofen or intrathecal injection.