NoL Index Variations Before and After a Stellate Ganglion Block

Chronic Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317782
• Other study ID #: 2017-1072
• Status: Completed
• Start date: October 23, 2017
• Est. completion date: April 4, 2019

Study information

• Verified date: September 2019
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 4, 2019
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Canada	Maisonneuve Rosemont Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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