Lumbar Sympathetic Ganglion Block Indication: Neuropathic Pain, CRPS, Hyperhydrosis Etc.NCT01648543
Comparison of Methods of Lumbar Sympathetic Ganglion Block: Distance vs Angle
A study testing lumbar sympathetic ganglion block in people with Lumbar Sympathetic Ganglion Block Indication: Neuropathic Pain, CRPS, Hyperhydrosis Etc., run by Yonsei University at 1 site in South Korea.
Trial summary
Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best method of lumbar sympathetic ganglion block is not established. The investigators would compare two methods of lumbar sympathetic ganglion block. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lumbar Sympathetic Ganglion Block Indication: Neuropathic Pain, CRPS, Hyperhydrosis Etc.
- What is being tested?
- lumbar sympathetic ganglion block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Dec 2012
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults above age of 20
- Undergoing lumbar sympathetic ganglion block indication
Who cannot join
- Infection
- Bleeding tendency
- Previous spinal surgery history
- Pregnancy
- Illiteracy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul
Jong Bum Choi, +82-2-2019-6093, ROMEOJB@yuhs.ac
About this study
Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best method of lumbar sympathetic ganglion block is not established. The investigators would compare two methods of lumbar sympathetic ganglion block. One is modified Reid method which's entry point is 7~7.5cm from midline of spinous process of lumbar spine. The other is angular method which's entry angle is 30 degree from anterior-posterior view of C-arm. Comparison modified Reid method with angular method would be helpful for finding best method of lumbar sympathetic ganglion block.
- Being tested
- lumbar sympathetic ganglion block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar sympathetic ganglion blockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| block method: angle | Active comparator | The entry angle of angular method which is one method of lumbar sympathetic ganglion block is 30 degree of anterior-posterior view of C-arm. Receives: Procedure: lumbar sympathetic ganglion block |
| block method: distance | Active comparator | The entry point of modified Reid method which is popular method of lumbar sympathetic ganglion block is 7~7.5cm from midline of spinous process of lumbar spine. Receives: Procedure: lumbar sympathetic ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
temperature change
Measured: 30min
muscle or vessel shadow
Measured: 30min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Sympathetic Ganglion Block Indication: Neuropathic Pain, CRPS, Hyperhydrosis Etc.Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jong bum Choi, Yonsei University
- Investigators
- Jong Bum Choi, Study director, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648543
- Sponsor's protocol ID
- 3-2012-0042
- Status last verified
- Jul 2012
- First submitted
- 19 Jul 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods of Lumbar Sympathetic Ganglion Block: Distance vs Angle
- ClinicalTrials.gov ID
- NCT01648543
- Acronym / sponsor ID
- 3-2012-0042
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 24 Jul 2012 (estimated)
- 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.
Lumbar sympathetic ganglion block is used for several neuropathic pain syndromes. The best method of lumbar sympathetic ganglion block is not established. The investigators would compare two methods of lumbar sympathetic ganglion block. One is modified Reid method which's entry point is 7~7.5cm from midline of spinous process of lumbar spine. The other is angular method which's entry angle is 30 degree from anterior-posterior view of C-arm. Comparison modified Reid method with angular method would be helpful for finding best method of lumbar sympathetic ganglion block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| block method: angle | Active comparator | Procedure: lumbar sympathetic ganglion blockThe entry angle of angular method which is one method of lumbar sympathetic ganglion block is 30 degree of anterior-posterior view of C-arm. |
| block method: distance | Active comparator | Procedure: lumbar sympathetic ganglion blockThe entry point of modified Reid method which is popular method of lumbar sympathetic ganglion block is 7~7.5cm from midline of spinous process of lumbar spine. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults above age of 20
- Undergoing lumbar sympathetic ganglion block indication
Key exclusion criteria (5 listed)
- Infection
- Bleeding tendency
- Previous spinal surgery history
- Pregnancy
- Illiteracy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar sympathetic ganglion block | Procedure or surgery | block method: angle, block method: distance |
Primary outcome
temperature change
Time frame: 30min
muscle or vessel shadow
Time frame: 30min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
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.
Jong Bum Choi study director
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar sympathetic ganglion block in people with Lumbar Sympathetic Ganglion Block Indication: Neuropathic Pain, CRPS, Hyperhydrosis Etc., run by Yonsei University 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Jul 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jong Bum Choi (+82-2-2019-6093, ROMEOJB@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
temperature change (time frame: 30min). The study lists 2 primary outcomes in all. 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 24 Jul 2012.