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Completed

NCT Number: NCT02148588

Peripheral Sensory Input in Central Post Stroke Pain (CPSP)

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.

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Key information

Conditions

Central Post Stroke Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound-guided peripheral nerve block with 2% lidocaine

Drug

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 outcomes

  1. 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"

Secondary outcomes

  1. Change in the Intensity of Cold Sensation

    Time frame: baseline and 30 min

    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)

  2. Change in the Intensity of Warm Sensation

    Time frame: baseline and 30 min

    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)

  3. Change in the Intensity of Pinprick Sensation

    Time frame: baseline and 30 min

    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)

  4. Change in the Intensity of Brush Sensation

    Time frame: baseline and 30 min

    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)

  5. Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire

    Time frame: baseline and 40 min

    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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

How "Central" is Central Post-stroke Pain? Investigating the Role of Peripheral Sensory Input in Maintaining Central Pain

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 28, 2014
Registry last updated
May 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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