NoL Index Variations Before and After a Stellate Ganglion Block

NCT03317782 | Completed

• 1 other identifier: 2017-1072
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in NoL index from baseline

  • 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 Outcomes (3)

• Change in peak NoL index values before and after a stellate ganglion block

  20 minutes

• change in Numeric Rating Scale (NRS) pain intensity score (from 0-10) before and 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

  20 minutes

Interventions

NoL index DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;
• years and older.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Maisonneuve Rosemont Hospital

Montreal, Quebec, h1t2m4, Canada

Location

Study Officials

• Veronique Brulotte, MD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 14, 2017
• First Posted: October 23, 2017
• Study Start: October 23, 2017
• Primary Completion: December 18, 2018
• Study Completion: April 4, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)