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

NCT02705950 | Completed

• 1 other identifier: 2014187
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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. 1.Spasticity and spasms (measured using the Modified Ashworth Scale and the Visual Analogue Scale and Penn Spasm Frequency Scale).
2. 2.Neurophysiological examination (warm perception threshold, heat pain perception threshold, evoked pain perception and contact heat evoked potentials).

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Neuropathic Pain Inventory Scale (NPIS)

  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

  Change from baseline in neuropathic pain at 4hours

Secondary Outcomes (8)

• Modified Ashworth Scale (MAS)

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

• Modified Penn Spasm Frequency Scale

  Change from baseline in spasticity at 4hours

• Visual Analogue Scale (VAS) for spasticity

  Change from baseline in spasticity at 4 hours

• warm and heat pain perception threshold

  Change from baseline in warm and pain perception at 4hours

• evoked pain perception

  Change from baseline in evoked acute pain perception at 4hours

Study Arms (2)

intrathecal baclofen bolus

ACTIVE COMPARATOR

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

Drug: Intrathecal baclofen bolus

placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Intrathecal baclofen bolus DRUG

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

Also known as: ITB bolus

intrathecal baclofen bolus

Placebo OTHER

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

Also known as: physiological saline

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who do not give patient inform consent.
• Contraindication for baclofen or intrathecal injection.

Sponsors & Collaborators

• Institut Guttmann: lead
• Medtronic: collaborator

Study Sites (1)

Institut Guttmann

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Hatice Kumru, MD PhD

  Neurologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 11, 2016
• Study Start: December 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)