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Completed

NCT Number: NCT02705950

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

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).

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Guttmann

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrathecal baclofen bolus

Drug

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

Other names: ITB bolus

Placebo

Other

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

Other names: physiological saline

Primary outcomes

  1. Neuropathic Pain Inventory Scale (NPIS)

    Time frame: 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

Secondary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: Change from baseline in spasticity at 1, 2 and 4hours

    is to measure spasticity in patients who have lesions of the central nervous system or neurological disorders.

  2. Modified Penn Spasm Frequency Scale

    Time frame: Change from baseline in spasticity at 4hours

    2 component self-report measure of the frequency of reported muscle spasms which is commonly used to quantify spasticity.

  3. Visual Analogue Scale (VAS) for spasticity

    Time frame: Change from baseline in spasticity at 4 hours

    Consists 10cm line for patient self-reporting of spasticity last 24hours

  4. warm and heat pain perception threshold

    Time frame: Change from baseline in warm and pain perception at 4hours

    it is quantitative sensory perception test for warm perception threshold and heat pain perception threshold

  5. evoked pain perception

    Time frame: Change from baseline in evoked acute pain perception at 4hours

    it is quantitative sensory perception test for acute induced pain perception measurement

  6. contact heat evoked potentials.

    Time frame: Change from baseline in evoked potential with heat pain at 4hours

    It is an evoked potential induced with heat painful stimulus

  7. Brief Pain Inventory (BPI)

    Time frame: Change from baseline in pain at 4hours

    The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function.

  8. Numerical Rating Scale (NRS) for neuropathic pain

    Time frame: Change from baseline in pain at 4hours

    Varies between 0-10 point (no pain- more severe pain) for patient self-reporting of pain for actual pain

Sponsors and collaborators

Lead sponsor

Institut Guttmann

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: ITB

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 11, 2016
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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