Central Post Stroke PainNCT02148588
Peripheral Sensory Input in Central Post Stroke Pain (CPSP)
A study testing Ultrasound-guided peripheral nerve block with 2% lidocaine in people with Central Post Stroke Pain, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked thermal and mechanical responses in CPSP, and assesses the associated local anesthetic pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Post Stroke Pain
- What is being tested?
- Ultrasound-guided peripheral nerve block with 2% lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 25 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Subjects will not be enrolled if any of the following criteria exist:
- Not giving consent to participate in the study;
- Significant psychiatric or cognitive impairment;
- Moderate to severe renal or liver failure;
- Concomitant treatment with warfarin or other anticoagulants;
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: How "Central" is Central Post-stroke Pain? Investigating the Role of Peripheral Sensory Input in Maintaining Central Pain
Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked thermal and mechanical responses in CPSP, and assesses the associated local anesthetic pharmacokinetics.
- Conditions
- Central Post Stroke Pain
- Being tested
- Ultrasound-guided peripheral nerve block with 2% lidocaine
- Keywords
- Central Post Stroke Pain, Nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided peripheral nerve block with 2% lidocaineDrug
Patients will have a peripheral nerve blockade with a local anesthetic (lidocaine)
Assessment of spontaneous and evoked pain responses
Completion of NPSI questionnaire
Mapping of the affected limb
| Study group | Role | What they receive |
|---|---|---|
| Pain testing | Experimental | Completion of NPSI questionnaire
Sensory mapping of the affected limb
Quantitative Sensory Testing
Patients will have a peripheral nerve blockade Receives: Drug: Ultrasound-guided peripheral nerve block with 2% lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block.
Reduction in spontaneous pain intensity in the painful extremity from baseline to 30 minutes after a peripheral nerve block.Spontaneous pain intensity was measured on 0-10 numerical rating scale (NRS), where 0 represents "no pain", and 10 represents "worst pain imaginable"
Measured: baseline and 30 minutes
Secondary outcomes (5)
Change in the Intensity of Cold Sensation
The intensity of cold sensation (application of roller cooled down to 20 degrees Celsius) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful cold); lower scores represent reduced sensitivity (0=no cold sensation)
Measured: baseline and 30 min
Change in the Intensity of Warm Sensation
The intensity of warm sensation (application of roller heated up to 40 degrees Celsius) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful hot); lower scores represent reduced sensitivity (0=no warmth sensation)
Measured: baseline and 30 min
Change in the Intensity of Pinprick Sensation
The intensity of pinprick sensation (application of Semmes-Weinstein monofilament #6.1, ~100g target force) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful sharp); lower scores represent reduced sensitivity (0=no pricking sensation)
Measured: baseline and 30 min
Change in the Intensity of Brush Sensation
The intensity of brush sensation (application of SENSELab Brush-05) was measured on 0-10 scale, where 5 represents "normal" sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful brushing sensation); lower scores represent reduced sensitivity (0=no brushing sensation)
Measured: baseline and 30 min
Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire
Composite scores on NPSI (Neuropathic Pain Symptom Inventory) questionnaire before and 40 minutes after the peripheral nerve block.
The NPSI assesses participant ranking of specific neuropathic pain descriptors, each ranked on a 0-10 scale, where 0 represents no burning/squeezing/electric shocks (etc), and 10 represents worst burning/squeezing/electric shocks (etc).
The scores on individual questions are grouped (averaged) into the three following subscales (each subscale scores ranging from 0 to 10):
- Burning pain
- Paroxysmal pain
- Paresthesia/dysesthesia
Measured: baseline and 40 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startAug 2014
- Primary completion15 Dec 2016
- Study completion25 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Post Stroke PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, simon.haroutounian, Washington University School of Medicine
- Investigators
- Simon Haroutounian, PHD, Principal investigator, Washington Univesity School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148588
- Sponsor's protocol ID
- 201405121
- Status last verified
- Apr 2018
- First submitted
- 15 May 2014
- Last updated
- 2 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How "Central" is Central Post-stroke Pain? Investigating the Role of Peripheral Sensory Input in Maintaining Central Pain
- ClinicalTrials.gov ID
- NCT02148588
- Acronym / sponsor ID
- 201405121
- Conditions
- Central Post Stroke Pain
- Keywords
- Central Post Stroke Pain, Nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Aug 2014
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 2 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked thermal and mechanical responses in CPSP, and assesses the associated local anesthetic pharmacokinetics.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain testing | Experimental | Drug: Ultrasound-guided peripheral nerve block with 2% lidocaineCompletion of NPSI questionnaire Sensory mapping of the affected limb Quantitative Sensory Testing Patients will have a peripheral nerve blockade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Not giving consent to participate in the study;
- Significant psychiatric or cognitive impairment;
- Moderate to severe renal or liver failure;
- Concomitant treatment with warfarin or other anticoagulants;
- Pregnancy or lactation.
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 |
|---|---|---|
| Ultrasound-guided peripheral nerve block with 2% lidocainePatients will have a peripheral nerve blockade with a local anesthetic (lidocaine) Assessment of spontaneous and evoked pain responses Completion of NPSI questionnaire Mapping of the affected limb | Drug | Pain testing |
Primary outcome
Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block.
Time frame: baseline and 30 minutes
Reduction in spontaneous pain intensity in the painful extremity from baseline to 30 minutes after a peripheral nerve block.Spontaneous pain intensity was measured on 0-10 numerical rating scale (NRS), where 0 represents "no pain", and 10 represents "worst pain imaginable"
5 secondary outcomes
Change in the Intensity of Cold Sensation
Time frame: baseline and 30 min
Change in the Intensity of Warm Sensation
Time frame: baseline and 30 min
Change in the Intensity of Pinprick Sensation
Time frame: baseline and 30 min
Change in the Intensity of Brush Sensation
Time frame: baseline and 30 min
Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire
Time frame: baseline and 40 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Central Post Stroke Pain
Not yet recruitingObservational study
Outcome Prediction and Recovery After Spontaneous Intracerebral Haemorrhage
Intracerebral Hemorrhage, Hemorrhagic Stroke
RecruitingPhase 2
Myofascial Dysfunction in Post Stroke Shoulder Pain
Stroke
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Recruiting
Post-stroke Pain tAN-fMRI
Post Stroke Pain
Not yet recruiting
Motor Cortex Stimulation for Post-Stroke Thalamic Pain
Central Post-stroke Pain, Stroke
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.
Simon Haroutounian, PHD principal investigator
Washington Univesity School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided peripheral nerve block with 2% lidocaine in people with Central Post Stroke Pain, run by Washington University School of Medicine at 1 site in United States.
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 0 inclusion and 6 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 2 May 2018. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 2 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. (time frame: baseline and 30 minutes). 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 2 May 2018.