Complex Regional Pain SyndromesNCT06470581
Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A
A study testing Botulinum toxin A in people with Complex Regional Pain Syndromes, run by Seoul National University.
Trial summary
Thoracic sympathetic ganglion block is a percutaneous procedure that paralyzes the action of sympathetic nerves transiently by injecting a local anesthetic around the ganglion. It is performed to diagnose and treat sympathetically maintained pain in phantom limb pain or complex reginal pain syndrome patient. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Complex Regional Pain Syndromes
- What is being tested?
- Botulinum toxin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 25 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 19-80 years
- Diagnosed with a complex regional pain syndrome (type 1 or 2) in unilateral upper extremity
- 11-point numerical-rating-scale (NRS) pain score of 4 or higher in upper extremity
- Temperature increase at diagnostic thoracic sympathetic ganglion block
- Patients taking medication stably (without change in dosage/recipe) for more than 4 weeks prior to administration
Who cannot join
- Refusal of the patient
- Vascular disease at upper extremity
- previous thoracic sympathetic neurolysis (thermocoagulation, chemical neurolysis)
- coagulopathy
- systemic infection or local infection at thoracic puncture site
- significant deformity at thoracic spine
Show all 12Show fewer
- neoplasm
- known allergic reaction with amide type local anesthetics
- cognitive dysfunction (not understanding of numerical-rating-scale)
- known allergic reaction with botulinum toxin
- pregnant or feeding women
- If the patient has participated in another clinical trial within 30 days before screening, or if passed no longer than 5-fold half-life of the clinical trial drug of the participating clinical trial
About this study
Official title: Clinical Effect of Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A in Patients With Upper Extremity Complex Regional Pain Syndrome: A Prospective Randomized, Double-blind, and Comparative Clinical Trial
Thoracic sympathetic ganglion block is a percutaneous procedure that paralyzes the action of sympathetic nerves transiently by injecting a local anesthetic around the ganglion. It is performed to diagnose and treat sympathetically maintained pain in phantom limb pain or complex reginal pain syndrome patient. The temperature of the affected arm is often lower than that of the opposite side. As a result of the procedure, the patient may experience sympathetic pain relief, such as coldness, stinging, numbness of the upper extremity. If the procedure does not last long, repetitive block or chemical neurolysis or radiofrequency thermocoagulation for the sympathetic ganglion is performed.
However, even though in rare cases, chemical neurolysis is known to cause permanent plexus injury radiofrequency thermocoagulation is known to be less successful than chemical neurolysis because it is difficult to identify and stimulate the exact location of the ganglion. Therefore, it is expected that there will be a benefit to the patients if there is a procedure with long-lasting and avoiding injury.
Recently, it has been reported that botulinum toxin (BTX) has been successfully used for the treatment of pain disorders. BTX plays a role with blocking the secretion of acetylcholine from the cholinergic nerve endings. Therefore, the use of BTX is expected to prolong the effect of neural blockade because pre-ganglia sympathetic nerves are cholinergic. It is also known that the action of BTX is not permanent and BTX does not exhibit cytotoxicity or neurotoxicity. Therefore, Botulinum toxin type A (BTA) is recommended for the treatment of migraine, myofascial pain syndrome, and neuropathic pain accompanied by allodynia. This study would like show whether thoracic sympathetic ganglion block using BTA has a longer duration than conventional local anesthesia by using prospective randomized, double-blind, parallel group, and comparative clinical trials.
- Conditions
- Complex Regional Pain Syndromes
- Being tested
- Botulinum toxin A
- 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.
Botulinum toxin ADrug
Patients were assigned 1:1 to a control group using only local anesthetics (Group A) and a BTX-A group (Group B). In Phase 1, the needle is inserted near the vertebrae T3 under fluoroscopic guidance. An 1 ml of non-ionized contrast medium is injected to evaluate the diffusion pattern, and 3ml of 0.75% ropivacaine is injected. After identifying a temperature increase in the ipsilateral palm within 20 min in the operating room with the prone position, 3 ml of 0.375% ropivacaine and botulinum toxin type A 75 IU mixed with 3 ml of non-preserved saline solution are injected in the patients in the control and botulinum toxin groups, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Local anesthetics | Active comparator | Total volume of 0.375% ropivacaine 3 mL will be injected in phase 2. Receives: Drug: Botulinum toxin A |
| Botulinum toxin A | Experimental | Total volume of BTX-A 75U in normal saline 3ml will be injected in phase 2. Receives: Drug: Botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in average pain intensity in 4weeks
Comparison between groups of the average change in 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable) over the past 24 hours
Measured: 4 weeks after procedure
Secondary outcomes (10)
The changes in average pain intensity in 12weeks
Comparison between groups of the average change in 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable) over the past 24 hours
Measured: 12 weeks after procedure
The changes in maximum pain intensity
Comparison between groups of the mamimum change in 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable) over the past 24 hours
Measured: 4 and 12 weeks after procedure
The changes in pain related to procedure
Inter- and intra-group comparison of the change in procedure-related 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable)
Measured: 30 minutes after the procedure
The change in the temperature difference
the change in the relative temperature difference on the blocked palm compared with the contralateral palm
Measured: 30 minutes, 4 and 12 weeks after the procedure
Blood flow velosity
Comparison between groups of blood flow velosity at brachial artery using ultrasound
Measured: 30 minutes, 4 and 12 weeks after the procedure
Korean CISS (Cold Intolerance Symptom Severity) Questionnaire
Inter- and intra-group comparison of the change in Korean CISS score from 4 to 100 (mild, 4-25; moderate, 26-50; severe, 51-75; and extremely severe, 76-100)
Measured: 4 and 12 weeks after the procedure
Paindetect questionare (PD-Q)
Inter- and intra-group comparison of the change in PD-Q score from 0 to 38 (total scores of less than 12 considered to represent nociceptive pain, 13-18 possible NeP, and >19 representing >90% likelihood of NeP)
Measured: 4 and 12 weeks after the procedure
Patient satisfaction
Patient satisfaction related to procedure using 5-pointed Likert scale (Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, and Very dissatisfied)
Measured: after procedure
Medication change (Opioids)
Comparison between groups of change with Morphine Equivalent Daily Dose (MEDD)
Measured: 4 and 12 weeks after the procedure
Additional intervention
Comparison between groups of total number of additional executed sympathetic blocks
Measured: 4 and 12 weeks 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 posted24 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion25 Apr 2026 (estimated)
- Study completion25 Apr 2027 (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 SyndromesStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470581
- Sponsor's protocol ID
- 2402-117-1516
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Thoracic Sympathetic Ganglion Block With Botulinum Toxin Type A in Patients With Upper Extremity Complex Regional Pain Syndrome: A Prospective Randomized, Double-blind, and Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT06470581
- Acronym / sponsor ID
- 2402-117-1516
- Conditions
- Complex Regional Pain Syndromes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 25 Apr 2027 (estimated)
- First posted
- 24 Jun 2024 (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.
Thoracic sympathetic ganglion block is a percutaneous procedure that paralyzes the action of sympathetic nerves transiently by injecting a local anesthetic around the ganglion. It is performed to diagnose and treat sympathetically maintained pain in phantom limb pain or complex reginal pain syndrome patient. The temperature of the affected arm is often lower than that of the opposite side. As a result of the procedure, the patient may experience sympathetic pain relief, such as coldness, stinging, numbness of the upper extremity. If the procedure does not last long, repetitive block or chemical neurolysis or radiofrequency thermocoagulation for the sympathetic ganglion is performed.
However, even though in rare cases, chemical neurolysis is known to cause permanent plexus injury radiofrequency thermocoagulation is known to be less successful than chemical neurolysis because it is difficult to identify and stimulate the exact location of the ganglion. Therefore, it is expected that there will be a benefit to the patients if there is a procedure with long-lasting and avoiding injury.
Recently, it has been reported that botulinum toxin (BTX) has been successfully used for the treatment of pain disorders. BTX plays a role with blocking the secretion of acetylcholine from the cholinergic nerve endings. Therefore, the use of BTX is expected to prolong the effect of neural blockade because pre-ganglia sympathetic nerves are cholinergic. It is also known that the action of BTX is not permanent and BTX does not exhibit cytotoxicity or neurotoxicity. Therefore, Botulinum toxin type A (BTA) is recommended for the treatment of migraine, myofascial pain syndrome, and neuropathic pain accompanied by allodynia. This study would like show whether thoracic sympathetic ganglion block using BTA has a longer duration than conventional local anesthesia by using prospective randomized, double-blind, parallel group, and comparative clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthetics | Active comparator | Drug: Botulinum toxin ATotal volume of 0.375% ropivacaine 3 mL will be injected in phase 2. |
| Botulinum toxin A | Experimental | Drug: Botulinum toxin ATotal volume of BTX-A 75U in normal saline 3ml will be injected in phase 2. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged 19-80 years
- Diagnosed with a complex regional pain syndrome (type 1 or 2) in unilateral upper extremity
- 11-point numerical-rating-scale (NRS) pain score of 4 or higher in upper extremity
- Temperature increase at diagnostic thoracic sympathetic ganglion block
- Patients taking medication stably (without change in dosage/recipe) for more than 4 weeks prior to administration
Key exclusion criteria (12 listed)
- Refusal of the patient
- Vascular disease at upper extremity
- previous thoracic sympathetic neurolysis (thermocoagulation, chemical neurolysis)
- coagulopathy
- systemic infection or local infection at thoracic puncture site
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 |
|---|---|---|
| Botulinum toxin APatients were assigned 1:1 to a control group using only local anesthetics (Group A) and a BTX-A group (Group B). In Phase 1, the needle is inserted near the vertebrae T3 under fluoroscopic guidance. An 1 ml of non-ionized contrast medium is injected to evaluate the diffusion pattern, and 3ml of 0.75% ropivacaine is injected. After identifying a temperature increase in the ipsilateral palm within 20 min in the operating room with the prone position, 3 ml of 0.375% ropivacaine and botulinum toxin type A 75 IU mixed with 3 ml of non-preserved saline solution are injected in the patients in the control and botulinum toxin groups, respectively. | Drug | Botulinum toxin A, Local anesthetics |
Primary outcome
The changes in average pain intensity in 4weeks
Time frame: 4 weeks after procedure
Comparison between groups of the average change in 11-point numerical rating scale pain score (0 = no pain, 10 = maximum pain imaginable) over the past 24 hours
10 secondary outcomes
The changes in average pain intensity in 12weeks
Time frame: 12 weeks after procedure
The changes in maximum pain intensity
Time frame: 4 and 12 weeks after procedure
The changes in pain related to procedure
Time frame: 30 minutes after the procedure
The change in the temperature difference
Time frame: 30 minutes, 4 and 12 weeks after the procedure
Blood flow velosity
Time frame: 30 minutes, 4 and 12 weeks after the procedure
Korean CISS (Cold Intolerance Symptom Severity) Questionnaire
Time frame: 4 and 12 weeks after the procedure
Paindetect questionare (PD-Q)
Time frame: 4 and 12 weeks after the procedure
Patient satisfaction
Time frame: after procedure
Medication change (Opioids)
Time frame: 4 and 12 weeks after the procedure
Additional intervention
Time frame: 4 and 12 weeks after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin A in people with Complex Regional Pain Syndromes, run by Seoul National University.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 changes in average pain intensity in 4weeks (time frame: 4 weeks after 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 26 Jun 2024.