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NoL Index Variations Before and After a Stellate Ganglion Block

Sponsor
Maisonneuve-Rosemont Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03317782
Collaborator
(none)
20
Enrollment
1
Location
17.3
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: NoL index

Study Design

Study Type:
Observational
Actual Enrollment :
20 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 :
Oct 23, 2017
Actual Primary Completion Date :
Dec 18, 2018
Actual Study Completion Date :
Apr 4, 2019

Outcome Measures

Primary Outcome Measures

  1. Change in NoL index from baseline [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Maisonneuve Rosemont Hospital Montréal Quebec Canada h1t2m4

Sponsors and Collaborators

  • Maisonneuve-Rosemont Hospital

Investigators

  • Principal Investigator: Veronique Brulotte, MD, Maisonneuve-Rosemont Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Veronique Brulotte, Dr, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT03317782
Other Study ID Numbers:
  • 2017-1072
First Posted:
Oct 23, 2017
Last Update Posted:
Sep 16, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Syndrome
Chronic Pain

Study Results

No Results Posted as of Sep 16, 2019