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Peripheral Sensory Input in Central Post Stroke Pain (CPSP)

Primary Purpose

Central Post Stroke Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound-guided peripheral nerve block with 2% lidocaine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Central Post Stroke Pain focused on measuring Central Post Stroke Pain, Nerve block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pain testing

Arm Description

Completion of NPSI questionnaire Sensory mapping of the affected limb Quantitative Sensory Testing Patients will have a peripheral nerve blockade

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

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)
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)
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)
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)
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

Full Information

First Posted
May 15, 2014
Last Updated
April 30, 2018
Sponsor
Washington University School of Medicine
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02148588
Brief Title
Peripheral Sensory Input in Central Post Stroke Pain (CPSP)
Official Title
How "Central" is Central Post-stroke Pain? Investigating the Role of Peripheral Sensory Input in Maintaining Central Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
January 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Post Stroke Pain
Keywords
Central Post Stroke Pain, Nerve block

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain testing
Arm Type
Experimental
Arm Description
Completion of NPSI questionnaire Sensory mapping of the affected limb Quantitative Sensory Testing Patients will have a peripheral nerve blockade
Intervention Type
Drug
Intervention Name(s)
Ultrasound-guided peripheral nerve block with 2% lidocaine
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block.
Description
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"
Time Frame
baseline and 30 minutes
Secondary Outcome Measure Information:
Title
Change in the Intensity of Cold Sensation
Description
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)
Time Frame
baseline and 30 min
Title
Change in the Intensity of Warm Sensation
Description
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)
Time Frame
baseline and 30 min
Title
Change in the Intensity of Pinprick Sensation
Description
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)
Time Frame
baseline and 30 min
Title
Change in the Intensity of Brush Sensation
Description
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)
Time Frame
baseline and 30 min
Title
Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire
Description
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
Time Frame
baseline and 40 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Haroutounian, PHD
Organizational Affiliation
Washington Univesity School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Peripheral Sensory Input in Central Post Stroke Pain (CPSP)

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