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

NCT ID: NCT02705950

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-08-31

Brief 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).

Detailed Description

The study will be a randomized, double-blind (patients and who will realize the clinical and neurophysiologic evaluation), placebo-controlled trial. We will recruit 10-12 patients with SCI with complete or incomplete lesion at cervical or thoracic level to be randomly distributed in two study groups: ITB bolus group and a placebo group.

In 6-8 months, we will administer an intrathecal baclofen bolus of 50 µg (1ml) in 5-6 SCI patients or 1ml of physiologic serum subcutaneously in the other 5-6 SCI patients.

Before the intrathecal baclofen or placebo bolus is administered, patients will be evaluated for neuropathic pain, using the Neuropathic Pain Inventory Scale, Brief Pain Inventory and Numerical Rating Scale. Spasticity and spasms will also be measured by the Modified Ashworth Scale, the Visual Analogue Scale and the Penn Spasm. After that, patients will also undergo, early in the morning when the intrathecal baclofen or placebo bolus will be administered, a neurophysiology assessment (warm perception threshold, heat pain perception threshold, evoked pain perception and contact heat evoked potentials).

After the neurophysiological evaluation, patients will receive an intrathecal baclofen bolus of 50 µg or placebo (randomization). After the intrathecal baclofen or placebo injection, a clinical and neurophysiological examination, of neuropathic pain and spasticity and spasms, will be repeated at 1, 2 and 4 hours after the bolus administration. Moreover, Kumru et al. (2013) reported that the 50 µg intrathecal baclofen bolus reduced the pain perception threshold and evoked acute pain perception in patients with SCI.

During all evaluation period, the patients continue with their analgesic, antispastic and/or any other stable medication.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

intrathecal baclofen bolus

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

Group Type: ACTIVE_COMPARATOR

Intrathecal baclofen bolus

Intervention Type: DRUG

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

placebo

In the placebo group: 1 ml of physiological saline (isotonic saline) will be injected subcutaneously at L3/L4 level simulating

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Intrathecal baclofen bolus

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

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

ITB bolus; physiological saline

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Institut Guttmann

OTHER

Sponsor Role: lead

Responsible Party

Hatice Kumru

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hatice Kumru, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Neurologist

Locations

Institut Guttmann

Badalona, Barcelona, Spain

Countries

Spain

Other Identifiers

2014187

Identifier Type: -

Identifier Source: org_study_id