PainNCT00637533
A Pilot Clinical Trial of Sympathetic Blockade With Botulinum Toxin Type A to Treat Complex Regional Pain Syndrome (CRPS): a Randomized, Double-Blind, Controlled, Crossover Trial.
A study testing Lumbar sympathetic block with Botulinum Toxin type A in people with Pain, run by Stanford University at 1 site in United States.
Trial summary
Lumbar sympathetic blocks are part of the standard of care for treating patients with sympathetically-maintained pain (e.g. in complex regional pain syndrome or reflex sympathetic dystrophy- RSD). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Lumbar sympathetic block with Botulinum Toxin type A
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to May 2007
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Severe pain in a lower extremity (greater than 6/10) of duration more than 6 months despite aggressive previous therapy including both previous lumbar sympathetic block, and previous trial of at least 4 different pain medications including at least 2 of the following: gabapentin, amitryptiline, desipramine, nortryptiline, imipramine, carbamazepine, valproic acid, mexiletine, oxcarbazepine, topiramate, lamotrigine, flecainide, zonisamide, venlafaxine and levetiracetam.
The severity of the pain must be such that the patient must perceive the function of the lower extremity to be compromised by the pain. Exclusion Criteria:Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy. Any ongoing legal action related to their pain. Any ongoing disability claim. A history of any severe psychiatric disorder. History of any adverse reaction to botulinum toxin. History of botulism. Untreated infection. Coagulopathy. Concurrent use of anticoagulant medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Lumbar sympathetic blocks are part of the standard of care for treating patients with sympathetically-maintained pain (e.g. in complex regional pain syndrome or reflex sympathetic dystrophy- RSD). In these patients lower extremity pain can be reduced or abolished temporarily by blocking sympathetic nerves by doing a lumbar sympathetic block. Patients who respond only transiently to sympathetic blocks often choose between potentially dangerous lumbar sympathetic block with neurolytic agents, surgical sympathectomy, continued severe refractory debilitating pain or other risky invasive surgical procedures such as spinal cord electrical stimulation.. It is hypothesized that Botulinum Toxin Type A (BTA) injected in a lumbar sympathetic block can provide extended sympathetic blockade and thus pain relief. This pilot study aims to see if BTA can be used safely in lower extremity sympathetic blocks, and might be useful in providing prolonged pain relief.
Read the detailed description
Lumbar sympathetic block will be performed twice on each patient: once as in the standard of practice with 10 cc 0.5% Bupivicaine and once with 75 units of Botox in 10cc of 0.5% Bupivicaine. These will be done in random order and the investigator and the patient will be blinded to which medicine they received. Two weeks after their pain has returned to 75% of their baseline they will receive the second of the blocks.
Lumbar sympathetic blockade in the standard fashion is accomplished by placing an IV in the patient. The patient is then placed face down on a fluoroscopy table. They are then prepped and draped in a sterile fashion. Conscious sedation is provided with versed and Fentanyl in the operating room with monitoring of blood pressure, pulse oximetry, and ekg. The skin is topicalized with one cc of 1% Lidocaine. The L2 lumbar vertebral body is identified and under fluoroscopic guidance a 22 gauge 6 inch spinal needle is placed at the anterolateral border of the L2 vertebral body. The retroperitoneal space is identified with a loss of resistance technique. Correct needle positioned is confirmed radiographically and appropriate spread of medications is verified by injecting 3 cc of radio opaque contrast material. The needle will be aspirated to verify that it is not intravascular. Ten cc of Bupivicaine 0.5% will then be injected in divided dose to ensure safety. Between injections the patient will be asked to report ringing in the ears or tingling in the mouth.
Subjects will be given a form asking them to rate their pain (from 0 to 10 where 0 is no pain and 10 is worst pain imaginable) at noon every day starting one week before the injection and continuing until they feel there pain has returned to baseline or two weeks whichever is longer. Days of analgesia will be the primary endpoint of the study.
- Conditions
- Pain
- Being tested
- Lumbar sympathetic block with Botulinum Toxin type A
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar sympathetic block with Botulinum Toxin type AProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline injection Receives: Procedure: Lumbar sympathetic block with Botulinum Toxin type A |
| Botulinum Toxin Type A | Experimental | Sympathetic Blockade containing Botulinum Toxin Type A Receives: Procedure: Lumbar sympathetic block with Botulinum Toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Analgesia
Measured: Duration of Trial
Secondary outcomes (1)
VAS Pain Score x Time
Measured: Duration of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startMay 2004
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Crossover
- Masking
- Double blind
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Investigators
- Ian R Carroll, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637533
- Sponsor's protocol ID
- SU-03102008-1034
- Status last verified
- Jan 2011
- First submitted
- 11 Mar 2008
- Last updated
- 19 Jan 2011
- Results posted
- No
Publications
Carroll I, Clark JD, Mackey S. Sympathetic block with botulinum toxin to treat complex regional pain syndrome. Ann Neurol. 2009 Mar;65(3):348-51. doi: 10.1002/ana.21601.
PubMed 19334078
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of Sympathetic Blockade With Botulinum Toxin Type A to Treat Complex Regional Pain Syndrome (CRPS): a Randomized, Double-Blind, Controlled, Crossover Trial.
- ClinicalTrials.gov ID
- NCT00637533
- Acronym / sponsor ID
- SU-03102008-1034
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 18 Mar 2008 (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 blocks are part of the standard of care for treating patients with sympathetically-maintained pain (e.g. in complex regional pain syndrome or reflex sympathetic dystrophy- RSD). In these patients lower extremity pain can be reduced or abolished temporarily by blocking sympathetic nerves by doing a lumbar sympathetic block. Patients who respond only transiently to sympathetic blocks often choose between potentially dangerous lumbar sympathetic block with neurolytic agents, surgical sympathectomy, continued severe refractory debilitating pain or other risky invasive surgical procedures such as spinal cord electrical stimulation.. It is hypothesized that Botulinum Toxin Type A (BTA) injected in a lumbar sympathetic block can provide extended sympathetic blockade and thus pain relief. This pilot study aims to see if BTA can be used safely in lower extremity sympathetic blocks, and might be useful in providing prolonged pain relief.
Detailed description
Lumbar sympathetic block will be performed twice on each patient: once as in the standard of practice with 10 cc 0.5% Bupivicaine and once with 75 units of Botox in 10cc of 0.5% Bupivicaine. These will be done in random order and the investigator and the patient will be blinded to which medicine they received. Two weeks after their pain has returned to 75% of their baseline they will receive the second of the blocks.
Lumbar sympathetic blockade in the standard fashion is accomplished by placing an IV in the patient. The patient is then placed face down on a fluoroscopy table. They are then prepped and draped in a sterile fashion. Conscious sedation is provided with versed and Fentanyl in the operating room with monitoring of blood pressure, pulse oximetry, and ekg. The skin is topicalized with one cc of 1% Lidocaine. The L2 lumbar vertebral body is identified and under fluoroscopic guidance a 22 gauge 6 inch spinal needle is placed at the anterolateral border of the L2 vertebral body. The retroperitoneal space is identified with a loss of resistance technique. Correct needle positioned is confirmed radiographically and appropriate spread of medications is verified by injecting 3 cc of radio opaque contrast material. The needle will be aspirated to verify that it is not intravascular. Ten cc of Bupivicaine 0.5% will then be injected in divided dose to ensure safety. Between injections the patient will be asked to report ringing in the ears or tingling in the mouth.
Subjects will be given a form asking them to rate their pain (from 0 to 10 where 0 is no pain and 10 is worst pain imaginable) at noon every day starting one week before the injection and continuing until they feel there pain has returned to baseline or two weeks whichever is longer. Days of analgesia will be the primary endpoint of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Procedure: Lumbar sympathetic block with Botulinum Toxin type ASaline injection |
| Botulinum Toxin Type A | Experimental | Procedure: Lumbar sympathetic block with Botulinum Toxin type ASympathetic Blockade containing Botulinum Toxin Type A |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 block with Botulinum Toxin type A | Procedure or surgery | Botulinum Toxin Type A, Placebo |
Primary outcome
Days of Analgesia
Time frame: Duration of Trial
1 secondary outcome
VAS Pain Score x Time
Time frame: Duration of trial
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 19 Jan 2011.
- Results publication: PubMed 19334078Carroll I, Clark JD, Mackey S. Sympathetic block with botulinum toxin to treat complex regional pain syndrome. Ann Neurol. 2009 Mar;65(3):348-51. doi: 10.1002/ana.21601.
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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.
Ian R Carroll principal investigator
Stanford 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 block with Botulinum Toxin type A in people with Pain, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Jan 2011. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Days of Analgesia (time frame: Duration of Trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00637533, which also lists 1 linked publication.
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 19 Jan 2011.