NoL Index Variations Before and After a Stellate Ganglion Block

Maisonneuve-Rosemont Hospital20 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Pain Syndrome

Interventions

NoL indexDEVICE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Maisonneuve Rosemont Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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)

Time frame: 20 minutes

Secondary Outcomes

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

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

Time frame: 20 minutes

change in Numeric Rating Scale (NRS) pain intensity score (from 0-10) before and after a stellate ganglion block

Measure the change in NRS pain intensity score after a painful physiotherapy exercise, before and 20 minutes after a stellate ganglion block.

Time frame: 20 minutes

correlation between change in NoL index and change in the Numeric Rating Scale (NRS) pain score (from 0-10) from baseline

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.

Time frame: 20 minutes

Data from ClinicalTrials.gov

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