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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
Sponsor:
Information provided by (Responsible Party):
Veronique Brulotte, Maisonneuve-Rosemont Hospital

Brief Summary:
To evaluate and compare the NoL index variations after a painful physiotherapy exercise in patients with upper limb CRPS, before and after a stellate ganglion block.

Condition or disease Intervention/treatment
Chronic Pain Syndrome Device: NoL index

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with upper extremity complex regional pain syndrome treated at the pain clinic of the Maisonneuve-Rosemont Hospital
Criteria

Inclusion Criteria:

  • Diagnosis of upper limb CRPS according to the Budapest criteria12, for more than 6 months;
  • Significant pain relief from stellate ganglion block;
  • Undergoing physical therapy;
  • 18 years and older.

Exclusion Criteria:

  • Patients taking beta blockers

    • Bilateral/generalized CRPS
    • Patients needing sedation for the procedure
    • Inability to understand a Numeric Pain rating Scale due to cognitive dysfunction or linguistic barrier
    • Movement disorder making a person unable to lie still for the duration of the evaluation period.
    • Patient refusal

Information from the National Library of Medicine

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


Contacts
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Contact: Veronique Brulotte, MD 514 242-3400 veronique.brulotte@umontreal.ca
Contact: Nadia Godin, RN 514 252-3400 ext 3193 n.godin.hmr@ssss.gouv.qc.ca

Locations
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Canada, Quebec
Maisonneuve Rosemont Hospital Recruiting
Montréal, Quebec, Canada, h1t2m4
Contact: Veronique Brulotte, MD    5144655025    veronique.brulotte@umontreal.ca   
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
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Principal Investigator: Veronique Brulotte, MD Maisonneuve-Rosemont Hospital

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Responsible Party: Veronique Brulotte, Dr, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT03317782     History of Changes
Other Study ID Numbers: 2017-1072
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Syndrome
Chronic Pain
Disease
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases