NoL Index Variations Before and After a Stellate Ganglion Block

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Pain Syndrome

Intervention / Treatment
-----------------
* Device: NoL index


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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