NoL Index Variations Before and After a Stellate Ganglion Block
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|ClinicalTrials.gov Identifier: NCT03317782|
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment|
|Chronic Pain Syndrome||Device: NoL index|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Evaluation of NoL Index Variations After a Painful Stimulus Before and After a Stellate Ganglion Block in Patients With Upper Extremity Complex Regional Pain Syndrome: a Pilot Study|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- Device: NoL index
The NoL/PMD-200 (Medasense Biometrics Ltd, Ramat Yishai, Israel) is a multi-parameter index (0-100) that incorporates heart rate, heart rate variability (0.15-0.4 Hz band power), plethysmograph wave amplitude, skin conductance level, number of skin conductance fluctuations (NSCF), and their time derivatives9 using a non-linear regression technique. A higher index indicates higher nociception, and an index <20 indicates adequate analgesia.
- Change in NoL index from baseline [ Time Frame: 20 minutes ]• Change in the NoL index after a painful physiotherapy exercise in patients with upper limb CRPS 20 minutes after a stellate ganglion block, from baseline (before the stellate ganglion block)
- Change in peak NoL index values before and after a stellate ganglion block [ Time Frame: 20 minutes ]Measure the change in peak NoL index (peak NoL index after a painful physiotherapy exercise before the stellate ganglion block minus the peak NoL index value after a painful physiotherapy exercise after the stellate ganglion block
- change in Numeric Rating Scale (NRS) pain intensity score (from 0-10) before and after a stellate ganglion block [ Time Frame: 20 minutes ]Measure the change in NRS pain intensity score after a painful physiotherapy exercise, before and 20 minutes after a stellate ganglion block.
- correlation between change in NoL index and change in the Numeric Rating Scale (NRS) pain score (from 0-10) from baseline [ Time Frame: 20 minutes ]Correlate the NoL index variation (delta NoL) with the NRS pain score variation (delta NRS) painful physiotherapy exercise in patients with upper limb CRPS, before and 20 minutes after a stellate ganglion block.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317782
|Contact: Veronique Brulotte, MD||514 email@example.com|
|Contact: Nadia Godin, RN||514 252-3400 ext firstname.lastname@example.org|
|Maisonneuve Rosemont Hospital||Recruiting|
|Montréal, Quebec, Canada, h1t2m4|
|Contact: Veronique Brulotte, MD 5144655025 email@example.com|
|Principal Investigator:||Veronique Brulotte, MD||Maisonneuve-Rosemont Hospital|