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

NCT02705950 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-08-08

No results posted yet for this study

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).

Conditions

  • Neuropathic Pain

Interventions

DRUG

Intrathecal baclofen bolus

An intrathecal baclofen bolus injection of 50 µg (1ml) will be injected at L3/L4 level.

OTHER

Placebo

1 ml of physiological saline (isotonic saline) will be injected subcutaneously at L3/L4 level simulating

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Institut Guttmann

    lead OTHER

Principal Investigators

  • Hatice Kumru, MD PhD · Neurologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Spain

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02705950 on ClinicalTrials.gov