NoL Index Variations Before and After a Stellate Ganglion Block

September 12, 2019 updated by: Veronique Brulotte, Maisonneuve-Rosemont Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, h1t2m4
        • Maisonneuve Rosemont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 minutes
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.
20 minutes
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.
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2017

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

April 4, 2019

Study Registration Dates

First Submitted

October 14, 2017

First Submitted That Met QC Criteria

October 18, 2017

First Posted (Actual)

October 23, 2017

Study Record Updates

Last Update Posted (Actual)

September 16, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-1072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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