Trial Outcomes & Findings for Peripheral Sensory Input in Central Post Stroke Pain (CPSP) (NCT NCT02148588)

Results Overview

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"

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

baseline and 30 minutes

Results posted on

2018-05-02

Participant Flow

Participant milestones

Participant milestones
Measure	The Entire Cohort All participants received a peripheral nerve block
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Peripheral Sensory Input in Central Post Stroke Pain (CPSP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Entire Cohort n=8 Participants All participants received a peripheral nerve block
Age, Continuous	51.6 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants
Region of Enrollment Denmark	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 30 minutes

Population: ITT

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"

Outcome measures

Outcome measures
Measure	The Entire Cohort n=8 Participants All participants received a peripheral nerve block
Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. Baseline pain intensity	6.5 units on a scale Interval 4.3 to 7.0
Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. Pain intensity after the block	0.0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: baseline and 30 min

Population: The entire cohort

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)

Outcome measures

Outcome measures
Measure	The Entire Cohort n=8 Participants All participants received a peripheral nerve block
Change in the Intensity of Cold Sensation Baseline	7 units on a scale Interval 4.5 to 7.8
Change in the Intensity of Cold Sensation 30 min after the block	0.0 units on a scale Interval 0.0 to 1.5

SECONDARY outcome

Timeframe: baseline and 30 min

Population: The entire cohort

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)

Outcome measures

Outcome measures
Measure	The Entire Cohort n=8 Participants All participants received a peripheral nerve block
Change in the Intensity of Warm Sensation Baseline	5.9 units on a scale Standard Deviation 1.4
Change in the Intensity of Warm Sensation 30 min after the block	0.5 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: baseline and 30 min

Population: The entire cohort

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)

Outcome measures

Outcome measures
Measure	The Entire Cohort n=8 Participants All participants received a peripheral nerve block
Change in the Intensity of Pinprick Sensation Baseline	5.0 units on a scale Standard Deviation 2.1
Change in the Intensity of Pinprick Sensation 30 min after block	1.1 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: baseline and 30 min

Population: The entire cohort

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)

Outcome measures

Outcome measures
Measure	The Entire Cohort n=8 Participants All participants received a peripheral nerve block
Change in the Intensity of Brush Sensation Baseline	4.5 units on a scale Standard Deviation 1.9
Change in the Intensity of Brush Sensation 30 min after block	1.0 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	The Entire Cohort n=8 Participants All participants received a peripheral nerve block
Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire Burning pain- baseline	4.1 units on a scale Standard Deviation 3.7
Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire burning pain - 40 min after block	0.0 units on a scale Standard Deviation 0.0
Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire paroxysmal pain - baseline	2.6 units on a scale Standard Deviation 2.1
Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire Paroxysmal pain - 40 min after block	0.0 units on a scale Standard Deviation 0.0
Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire paresthesia/dysesthesia - baseline	3.6 units on a scale Standard Deviation 3.3
Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire paresthesia/dysesthesia - 40 min after block	0.9 units on a scale Standard Deviation 1.3

Adverse Events

The Entire Cohort

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	The Entire Cohort n=8 participants at risk All participants received a peripheral nerve block
Nervous system disorders Perioral numbness	25.0% 2/8 • Number of events 2 • 48 hours
Nervous system disorders Dizziness	12.5% 1/8 • Number of events 1 • 48 hours
Nervous system disorders Vasovagal response	12.5% 1/8 • Number of events 1 • 48 hours

Additional Information

Simon Haroutounian

Washington University School of Medicine

Phone: 3142861715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place