Skip to main content
OpenTrials
Completed

NCT Number: NCT03317782

NoL Index Variations Before and After a Stellate Ganglion Block

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maisonneuve Rosemont Hospital

Montreal, Quebec, h1t2m4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in NoL index from baseline

    Time frame: 20 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 outcomes

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

    Time frame: 20 minutes

    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

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

    Time frame: 20 minutes

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

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

    Time frame: 20 minutes

    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.

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 23, 2017
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.