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NoL Index Variations Before and After a Stellate Ganglion Block

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03317782
Enrollment
20
Registered
2017-10-23
Start date
2017-10-23
Completion date
2019-04-04
Last updated
2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain Syndrome

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.

Interventions

DEVICENoL 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.

Sponsors

Maisonneuve-Rosemont Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in NoL index from baseline20 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)

Secondary

MeasureTime frameDescription
Change in peak NoL index values before and after a stellate ganglion block20 minutesMeasure 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
change in Numeric Rating Scale (NRS) pain intensity score (from 0-10) before and after a stellate ganglion block20 minutesMeasure the change in NRS pain intensity score after a painful physiotherapy exercise, before and 20 minutes after a stellate ganglion block.
correlation between change in NoL index and change in the Numeric Rating Scale (NRS) pain score (from 0-10) from baseline20 minutesCorrelate 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026