Neuropathic PainITBNCT02705950
Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP). Preliminary Study.
A study testing Intrathecal baclofen bolus in people with Neuropathic Pain, run by Institut Guttmann at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Intrathecal baclofen bolus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2014to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who do not give patient inform consent.
- Contraindication for baclofen or intrathecal injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP) in Spinal Cord Injury (SCI) Patients. 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.
Read more
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:
- Spasticity and spasms (measured using the Modified Ashworth Scale and the Visual Analogue Scale and Penn Spasm Frequency Scale).
- Neurophysiological examination (warm perception threshold, heat pain perception threshold, evoked pain perception and contact heat evoked potentials).
Read the 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
- Being tested
- Intrathecal baclofen bolus, Placebo
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal baclofen bolusDrug
Also called ITB bolus
An intrathecal baclofen bolus injection of 50 µg (1ml) will be injected at L3/L4 level.
PlaceboOther
Also called physiological saline
1 ml of physiological saline (isotonic saline) will be injected subcutaneously at L3/L4 level simulating
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline in neuropathic pain at 4hours
Secondary outcomes (8)
Modified Ashworth Scale (MAS)
is to measure spasticity in patients who have lesions of the central nervous system or neurological disorders.
Measured: Change from baseline in spasticity at 1, 2 and 4hours
Modified Penn Spasm Frequency Scale
2 component self-report measure of the frequency of reported muscle spasms which is commonly used to quantify spasticity.
Measured: Change from baseline in spasticity at 4hours
Visual Analogue Scale (VAS) for spasticity
Consists 10cm line for patient self-reporting of spasticity last 24hours
Measured: Change from baseline in spasticity at 4 hours
warm and heat pain perception threshold
it is quantitative sensory perception test for warm perception threshold and heat pain perception threshold
Measured: Change from baseline in warm and pain perception at 4hours
evoked pain perception
it is quantitative sensory perception test for acute induced pain perception measurement
Measured: Change from baseline in evoked acute pain perception at 4hours
contact heat evoked potentials.
It is an evoked potential induced with heat painful stimulus
Measured: Change from baseline in evoked potential with heat pain at 4hours
Brief Pain Inventory (BPI)
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.
Measured: Change from baseline in pain at 4hours
Numerical Rating Scale (NRS) for neuropathic pain
Varies between 0-10 point (no pain- more severe pain) for patient self-reporting of pain for actual pain
Measured: Change from baseline in pain at 4hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startDec 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Guttmann
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Hatice Kumru, Institut Guttmann
- Investigators
- Hatice Kumru, MD PhD, Principal investigator, Neurologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705950
- Sponsor's protocol ID
- 2014187
- Acronym
- ITB
- Status last verified
- Aug 2019
- First submitted
- 25 Feb 2016
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP) in Spinal Cord Injury (SCI) Patients. Preliminary Study.
- ClinicalTrials.gov ID
- NCT02705950
- Acronym / sponsor ID
- ITB / 2014187
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Institut GuttmannUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Dec 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Spasticity and spasms (measured using the Modified Ashworth Scale and the Visual Analogue Scale and Penn Spasm Frequency Scale).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrathecal baclofen bolus | Active comparator | Drug: Intrathecal baclofen bolusIn ITB bolus group: An intrathecal baclofen bolus injection of 50 µg (1ml) will be injected at L3/L4 level. A 50 µg. |
| placebo | Placebo comparator | Other: PlaceboIn the placebo group: 1 ml of physiological saline (isotonic saline) will be injected subcutaneously at L3/L4 level simulating |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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>=).
Key exclusion criteria (2 listed)
- Patients who do not give patient inform consent.
- Contraindication for baclofen or intrathecal injection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal baclofen bolusAlso: ITB bolusAn intrathecal baclofen bolus injection of 50 µg (1ml) will be injected at L3/L4 level. | Drug | intrathecal baclofen bolus |
| PlaceboAlso: physiological saline1 ml of physiological saline (isotonic saline) will be injected subcutaneously at L3/L4 level simulating | Other | placebo |
Primary outcome
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
8 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Change from baseline in spasticity at 1, 2 and 4hours
Modified Penn Spasm Frequency Scale
Time frame: Change from baseline in spasticity at 4hours
Visual Analogue Scale (VAS) for spasticity
Time frame: Change from baseline in spasticity at 4 hours
warm and heat pain perception threshold
Time frame: Change from baseline in warm and pain perception at 4hours
evoked pain perception
Time frame: Change from baseline in evoked acute pain perception at 4hours
contact heat evoked potentials.
Time frame: Change from baseline in evoked potential with heat pain at 4hours
Brief Pain Inventory (BPI)
Time frame: Change from baseline in pain at 4hours
Numerical Rating Scale (NRS) for neuropathic pain
Time frame: Change from baseline in pain at 4hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatice Kumru, MD PhD principal investigator
Neurologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal baclofen bolus in people with Neuropathic Pain, run by Institut Guttmann at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic Pain Inventory Scale (NPIS) (time frame: Change from baseline in neuropathic pain at 4hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.