Measurement of the Skin Sympathetic Nerve Activity During Stellate, Thoracic, and Lumbar Sympathetic Ganglia Block

November 20, 2023 updated by: Yunseok Jeon, Seoul National University Hospital

Recording Sympathetic Nerve Activity From the Skin During Stellate, Thoracic, and Lumbar Sympathetic Ganglia Block : a Pilot Study

Sympathetic nerve activity can be measured transcutaneously in awake patients by computer-based filtering of raw signal obtained via skin leads attached on the chest and the right arm. Electrocardiogram can be removed by applying a high-pass filter setting of 150 Hz. Electromyogram can be filtered by applying a high-pass filter setting of 500 Hz or a band-pass filter setting of 500-1000 Hz.

Currently, the therapeutic effect of stellate, thoracic, and lumbar sympathetic ganglia block (SGB, TSGB, and LSGB, respectively) in patients with chronic pain is generally evaluated by using thermogram/thermography (change in temperature of the upper or lower extremeties) or questionnaire-based scoring.

However, it is not known whether the skin sympathetic nerve activity (SKNA) can be measured in patients undergoing SGB/TSGB/LSGB and used as an alternative tool for assessing the therapeutic effect of SGB/TSGB/LSGB.

Therefore, we planned this pilot study to observe whether the SKNA can be obtained in patients undergoing SGB/TSGB/LSGB and whether it is well correlated to thermogram or questionnaire-based scoring. If the SKNA is observed and decreases after SGB/TSGB/LSGB, it will be presented in milivolt (uV) and compared to that of pre-block values.

Study Overview

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 03080
        • Department of Anesthesiology and Pain Medicine, Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing stellate, thoracic, or lumbar sympathetic block for control of chronic neuropathic pain

Description

Inclusion Criteria:

  • Outpatient patients undergoing stellate, thoracic, and lumbar sympathetic block for chronic pain disease

Exclusion Criteria:

  • patients denial
  • peripheral vascular disease in the head and the upper extremities.
  • prior thoracic sympathectomy/sympathicotomy
  • prior resection or ablation (chemically or mechanically) of stellate, thoracic, and lumbar sympathetic
  • coagulapathy
  • infectious disease
  • allergy to local anesthetics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The skin sympathetic nerve activity presented as uV obtained via skin leads.
Time Frame: From the beginning of stellate, thoracic, or lumbar sympathetic block procedure and the next outpatient visiting 4 weeks (an average) after the procedure.
A few studies reported that skin sympathetic nerve activity (SKNA) signal could be potentially observed by applying a high-pass filter of 500 Hz or a band-pass filter of 500~1000 Hz to electric signal from skin leads attached on the skin of the chest in awake volunteers. However, it is not known if it would be also possible to observe the SKNA signal in patients undergoing stellate, thoracic, and lumbar sympathetic block. Also, there is no established, objective tool for quantitative or qualitative assessment of the effect of stellate, thoracic, and lumbar sympathetic block.
From the beginning of stellate, thoracic, or lumbar sympathetic block procedure and the next outpatient visiting 4 weeks (an average) after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2019

Primary Completion (Actual)

April 8, 2020

Study Completion (Actual)

May 6, 2020

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SGB SKNA pilot

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain Requiring Stellate, Thoracic, and Lumbar Sympathetic Ganglia Blockade

  • Tobias Moeller-Bertram
    University of California, San Diego; Metamorphosis, LLC
    Enrolling by invitation
    Depression | Heart Failure | Stroke | Epilepsy | Lymphoma | Multiple Sclerosis | Hypertension | Ovarian Cysts | Diabetes | Cerebral Palsy | Macular Degeneration | Chronic Kidney Diseases | Osteoarthritis | Hypothyroidism | Rheumatoid Arthritis | Infertility | Parkinson Disease | Migraine | Atrial Fibrillation | Psoriasis | Asthma | Fibro... and other conditions
    United States
  • Global Healthy Living Foundation
    University of Alabama at Birmingham
    Recruiting
    Heart Failure | Stroke | Epilepsy | Multiple Sclerosis | Obesity | Diabetes | Chronic Obstructive Pulmonary Disease | Osteoarthritis | Rheumatoid Arthritis | Parkinson Disease | Peripheral Arterial Disease | Inflammatory Bowel Diseases | Amyotrophic Lateral Sclerosis | Psoriasis | Asthma | Muscular Dystrophy | Fibromyalgia | Alzheimer... and other conditions
    United States
  • ProgenaBiome
    Suspended
    Depression | Multiple Sclerosis | Diabetes | Cancer | Parkinson Disease | Constipation | Migraine | Amyotrophic Lateral Sclerosis | Psoriasis | Anxiety | Alzheimer Disease | Bipolar and Related Disorders | Celiac Disease | Eczema | Autism Spectrum Disorder | Mesothelioma | Colon Cancer | Amyotrophic Lateral Sclerosis (ALS) | Gout | Lyme Arthritis and other conditions
    United States
Subscribe