Peripheral Sensory Input in Central Post Stroke Pain (CPSP)

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.

Study Overview

• Status: Completed
• Conditions: Central Post Stroke Pain
• Intervention / Treatment: Drug: Ultrasound-guided peripheral nerve block with 2% lidocaine

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Each subject must meet all of the following criteria:

• Age ≥18;
• CPSP affecting an upper or a lower limb, in a distribution that may be completely covered by a peripheral nerve block;
• Patient fulfills all mandatory criteria for CPSP, fulfills at least one supportive criteria, and has definite CPSP by probability grading.
• Pain duration at least 3 months;
• Spontaneous pain intensity (average pain in past week) of ≥ 4 on 0-10 Numerical Rating Scale (NRS).

Exclusion Criteria

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain testing; Completion of NPSI questionnaire Sensory mapping of the affected limb Quantitative Sensory Testing Patients will have a peripheral nerve blockade	Drug: Ultrasound-guided peripheral nerve block with 2% lidocaine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	baseline and 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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	baseline and 40 min

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Simon Haroutounian, PHD, Washington Univesity School of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 15, 2016
• Study Completion (Actual): January 25, 2017

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Nerve block; Central Post Stroke Pain
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 201405121