Complex Regional Pain SyndromePhase 3park001NCT01134289
Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block
A Phase 3 study testing lumbar sympathetic block in people with Complex Regional Pain Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to compare the alternative current and the direct current signal changes of photoplethysmography between both feet during one side lumbar sympathetic block. The hypothesis is that signal changes occur earlier than other indices to decide whether it is successful following lumbar sympathetic block on… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Complex Regional Pain Syndrome
- What is being tested?
- lumbar sympathetic block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2009to Feb 2010
- Phase
- Phase 3
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physically examined for complex regional pain syndrome on lower extremity,
- Scheduled for diagnostic lumbar sympathetic blockade.
Who cannot join
- Graded as ASA 3 or higher,
- Below 18 or above 70 years of age, or
- Had any other contraindication for regional anesthesia.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Seoul, 110744
Soo Young Park, MD, 82-2-2072-0881, soo02@snu.ac.kr
About this study
Official title: An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome
This study aims to compare the alternative current and the direct current signal changes of photoplethysmography between both feet during one side lumbar sympathetic block.
The hypothesis is that signal changes occur earlier than other indices to decide whether it is successful following lumbar sympathetic block on only one-side.
- Conditions
- Complex Regional Pain Syndrome
- Being tested
- lumbar sympathetic block
- Keywords
- complex regional pain syndrome, lumbar sympathetic blockade, photoplethysmography, diagnostic lumbar sympathetic blockade
- Medical subject headings
- Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar sympathetic blockProcedure or surgery
Also called 0.25% bupivacaine (Chirocaine, Abbott, Elverum, Norway), C-arm (OEC 9800 plus, GE Medical Systems, Salt Lake City, UT), Chiba needle (Cook Inc., Bloomington, IN)
unilateral lumbar sympathetic block at L3 level using 0.2% chirocaine under C-arm fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| lumbar sympathetic block | Active comparator | Unilateral lumbar sympathetic blockade using chirocaine Receives: Procedure: lumbar sympathetic block |
| contralateral side | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of sympathetic block
change of slope of signals of the alternative current and the direct current from foot
The baseline is defined as the point of surgical drap.
The end of procedure is decided when the temperature of foot is increased more than 2 degrees from baseline within 20 minutes after local anesthetics injection
Measured: 1 minute at intervals from baseline through end of procedure
Secondary outcomes (2)
skin temperature changes
foot temperature change from baseline
Measured: 1 minute at intervals during procedure
electrocardiogram
heart rate variability measurement
Measured: 1 minute at intervals from baseline through end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromeStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134289
- Sponsor's protocol ID
- Seoul National Univ Hospital
- Other IDs
- H-0906-010-282
- Acronym
- park001
- Status last verified
- Jun 2010
- First submitted
- 19 May 2010
- Last updated
- 7 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome
- ClinicalTrials.gov ID
- NCT01134289
- Acronym / sponsor ID
- park001 / Seoul National Univ Hospital
- Conditions
- Complex Regional Pain Syndrome
- Keywords
- complex regional pain syndrome, lumbar sympathetic blockade, photoplethysmography, diagnostic lumbar sympathetic blockade
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (estimated)
- First posted
- 31 May 2010 (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.
This study aims to compare the alternative current and the direct current signal changes of photoplethysmography between both feet during one side lumbar sympathetic block.
The hypothesis is that signal changes occur earlier than other indices to decide whether it is successful following lumbar sympathetic block on only one-side.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumbar sympathetic block | Active comparator | Procedure: lumbar sympathetic blockUnilateral lumbar sympathetic blockade using chirocaine |
| contralateral side | No intervention | – |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physically examined for complex regional pain syndrome on lower extremity,
- Scheduled for diagnostic lumbar sympathetic blockade.
Key exclusion criteria (3 listed)
- Graded as ASA 3 or higher,
- Below 18 or above 70 years of age, or
- Had any other contraindication for regional anesthesia.
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 blockAlso: 0.25% bupivacaine (Chirocaine, Abbott, Elverum, Norway), C-arm (OEC 9800 plus, GE Medical Systems, Salt Lake City, UT), Chiba needle (Cook Inc., Bloomington, IN)unilateral lumbar sympathetic block at L3 level using 0.2% chirocaine under C-arm fluoroscopy | Procedure or surgery | lumbar sympathetic block |
Primary outcome
Index of sympathetic block
Time frame: 1 minute at intervals from baseline through end of procedure
change of slope of signals of the alternative current and the direct current from foot The baseline is defined as the point of surgical drap. The end of procedure is decided when the temperature of foot is increased more than 2 degrees from baseline within 20 minutes after local anesthetics injection
2 secondary outcomes
skin temperature changes
Time frame: 1 minute at intervals during procedure
electrocardiogram
Time frame: 1 minute at intervals from baseline through end of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2010.
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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.
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lumbar sympathetic block in people with Complex Regional Pain Syndrome, 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 2 inclusion and 3 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 7 Jun 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index of sympathetic block (time frame: 1 minute at intervals from baseline through end of 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 7 Jun 2010.