Peripheral Sensory Input in Central Post Stroke Pain (CPSP)
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block. [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 Outcome Measures
- Change in the Intensity of Cold Sensation [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)
- Change in the Intensity of Warm Sensation [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)
- Change in the Intensity of Pinprick Sensation [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)
- Change in the Intensity of Brush Sensation [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)
- Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire [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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- Aarhus University Hospital
Investigators
- Principal Investigator: Simon Haroutounian, PHD, Washington Univesity School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201405121
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | The Entire Cohort |
|---|---|
| Arm/Group Description | All participants received a peripheral nerve block |
| Period Title: Overall Study | |
| STARTED | 8 |
| COMPLETED | 8 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | The Entire Cohort |
|---|---|
| Arm/Group Description | All participants received a peripheral nerve block |
| Overall Participants | 8 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
51.6
(7.4)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
50%
|
| Male |
4
50%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
5
62.5%
|
| White |
3
37.5%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
7
87.5%
|
| Denmark |
1
12.5%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | The Entire Cohort |
|---|---|
| Arm/Group Description | All participants received a peripheral nerve block |
| Measure Participants | 8 |
| Baseline pain intensity |
6.5
|
| Pain intensity after the block |
0.0
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The entire cohort |
| Arm/Group Title | The Entire Cohort |
|---|---|
| Arm/Group Description | All participants received a peripheral nerve block |
| Measure Participants | 8 |
| Baseline |
7
|
| 30 min after the block |
0.0
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The entire cohort |
| Arm/Group Title | The Entire Cohort |
|---|---|
| Arm/Group Description | All participants received a peripheral nerve block |
| Measure Participants | 8 |
| Baseline |
5.9
(1.4)
|
| 30 min after the block |
0.5
(1.1)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The entire cohort |
| Arm/Group Title | The Entire Cohort |
|---|---|
| Arm/Group Description | All participants received a peripheral nerve block |
| Measure Participants | 8 |
| Baseline |
5.0
(2.1)
|
| 30 min after block |
1.1
(2.2)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The entire cohort |
| Arm/Group Title | The Entire Cohort |
|---|---|
| Arm/Group Description | All participants received a peripheral nerve block |
| Measure Participants | 8 |
| Baseline |
4.5
(1.9)
|
| 30 min after block |
1.0
(1.4)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | The Entire Cohort |
|---|---|
| Arm/Group Description | All participants received a peripheral nerve block |
| Measure Participants | 8 |
| Burning pain- baseline |
4.1
(3.7)
|
| burning pain - 40 min after block |
0.0
(0.0)
|
| paroxysmal pain - baseline |
2.6
(2.1)
|
| Paroxysmal pain - 40 min after block |
0.0
(0.0)
|
| paresthesia/dysesthesia - baseline |
3.6
(3.3)
|
| paresthesia/dysesthesia - 40 min after block |
0.9
(1.3)
|
Adverse Events
| Time Frame | 48 hours | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | The Entire Cohort | |
| Arm/Group Description | All participants received a peripheral nerve block | |
All Cause Mortality |
||
| The Entire Cohort | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | |
Serious Adverse Events |
||
| The Entire Cohort | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/8 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| The Entire Cohort | ||
| Affected / at Risk (%) | # Events | |
| Total | 4/8 (50%) | |
| Nervous system disorders | ||
| Perioral numbness | 2/8 (25%) | 2 |
| Dizziness | 1/8 (12.5%) | 1 |
| Vasovagal response | 1/8 (12.5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Simon Haroutounian |
|---|---|
| Organization | Washington University School of Medicine |
| Phone | 3142861715 ext 314 |
| simon.haroutounian@wustl.edu |
- 201405121