Peripheral Sensory Input in Central Post Stroke Pain (CPSP)

Central Post Stroke Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148588
• Other study ID #: 201405121
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: January 25, 2017

Study information

• Verified date: April 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 25, 2017
• Est. primary completion date: December 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Post Stroke Pain
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Aarhus University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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