Chronic Pain Requiring Stellate, Thoracic, and Lumbar Sympathetic Ganglia BlockadeNCT03902860
Measurement of the Skin Sympathetic Nerve Activity During Stellate, Thoracic, and Lumbar Sympathetic Ganglia Block
An observational study of Chronic Pain Requiring Stellate, Thoracic, and Lumbar Sympathetic Ganglia Blockade, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pain Requiring Stellate, Thoracic, and Lumbar Sympathetic Ganglia Blockade
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2019to 6 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing stellate, thoracic, or lumbar sympathetic block for control of chronic neuropathic pain
Who may be able to join
- Outpatient patients undergoing stellate, thoracic, and lumbar sympathetic block for chronic pain disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Seoul, 03080
About this study
Official title: 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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The skin sympathetic nerve activity presented as uV obtained via skin leads.
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.
Measured: From the beginning of stellate, thoracic, or lumbar sympathetic block procedure and the next outpatient visiting 4 weeks (an average) after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start15 May 2019
- Primary completion8 Apr 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain Requiring Stellate, Thoracic, and Lumbar Sympathetic Ganglia BlockadeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902860
- Sponsor's protocol ID
- SGB SKNA pilot
- Status last verified
- Nov 2023
- First submitted
- 2 Apr 2019
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording Sympathetic Nerve Activity From the Skin During Stellate, Thoracic, and Lumbar Sympathetic Ganglia Block : a Pilot Study
- ClinicalTrials.gov ID
- NCT03902860
- Acronym / sponsor ID
- SGB SKNA pilot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing stellate, thoracic, or lumbar sympathetic block for control of chronic neuropathic pain
Key inclusion criteria (1 listed)
- Outpatient patients undergoing stellate, thoracic, and lumbar sympathetic block for chronic pain disease
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain Requiring Stellate, Thoracic, and Lumbar Sympathetic Ganglia Blockade, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.