Complex Regional Pain Syndrome I of Upper LimbPhase 3NCT01612364
RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
A Phase 3 study testing thoracic sympathetic block in people with Complex Regional Pain Syndrome I of Upper Limb, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndrome I of Upper Limb
- What is being tested?
- thoracic sympathetic block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Nov 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complex regional pain syndrome (IASP, 1994) involving an upper limb;
- Pain scores in excess of five visual analog scale (VAS);
- Poor outcome to treatment (less than 50% reduction in VAS scores) -
Who cannot join
- History of severe brain injury, epilepsy and stroke
- Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique
- Severe systemic disease
- Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated
- Refusal to participate or not initial adherence to orientations
- Refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo
São Paulo, São Paulo, 05403000
Roberto O Rocha, MD, 5511 82668553, contato@drrobertorocha.com.br
Roberto O Rocha, MD
About this study
Official title: Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
This is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and WHOQOL-brief).
- Being tested
- thoracic sympathetic block
- Keywords
- CRPS I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic sympathetic blockProcedure or surgery
Also called T2-T3 thoracic sympathetic block, T3 sympathetic block, T2-T3 thoracic dorsal sympathetic block, thoracic sympathetic ganglion block
Thoracic sympathetic block is sympathetic block of upper limb described by Leriche e Fontaine em 1925. The block is performed under radioscopic view, positioning the needle lateral the body of thoracic vertebra T3, where infuse anesthetic solution. The theoretical advantage over the stellate ganglion is its greater specificity and efficiency. Solution block: 5ml ropivacaine 0,75% + 5ml de triamcinolone 2%
| Study group | Role | What they receive |
|---|---|---|
| thoracic sympathetic block | Experimental | Sympathetic block of upper limb via thoracic vertebra T3 Receives: Procedure: thoracic sympathetic block |
| control block | Active comparator | Same medication used in experimental group, but in dorsal subcutaneous Receives: Procedure: thoracic sympathetic block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesia after block
Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
Measured: 1 month
Secondary outcomes (1)
analgesia quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startJan 2010
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (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 Syndrome I of Upper LimbStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Responsible party
- Principal investigator, Roberto O Rocha, University of Sao Paulo
- Investigators
- Roberto O Rocha, MD, Principal investigator, Hospital das Clinicas Faculty of Medicine University Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612364
- Sponsor's protocol ID
- 5138 - 1805142/1
- Status last verified
- Jun 2012
- First submitted
- 30 May 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
- ClinicalTrials.gov ID
- NCT01612364
- Acronym / sponsor ID
- 5138 - 1805142/1
- Keywords
- CRPS I
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo General Hospital
- Study start
- Jan 2010
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 5 Jun 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.
This is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and WHOQOL-brief).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thoracic sympathetic block | Experimental | Procedure: thoracic sympathetic blockSympathetic block of upper limb via thoracic vertebra T3 |
| control block | Active comparator | Procedure: thoracic sympathetic blockSame medication used in experimental group, but in dorsal subcutaneous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Complex regional pain syndrome (IASP, 1994) involving an upper limb;
- Pain scores in excess of five visual analog scale (VAS);
- Poor outcome to treatment (less than 50% reduction in VAS scores) -
Key exclusion criteria (6 listed)
- History of severe brain injury, epilepsy and stroke
- Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique
- Severe systemic disease
- Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated
- Refusal to participate or not initial adherence to orientations
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 |
|---|---|---|
| thoracic sympathetic blockAlso: T2-T3 thoracic sympathetic block, T3 sympathetic block, T2-T3 thoracic dorsal sympathetic block, thoracic sympathetic ganglion blockThoracic sympathetic block is sympathetic block of upper limb described by Leriche e Fontaine em 1925. The block is performed under radioscopic view, positioning the needle lateral the body of thoracic vertebra T3, where infuse anesthetic solution. The theoretical advantage over the stellate ganglion is its greater specificity and efficiency. Solution block: 5ml ropivacaine 0,75% + 5ml de triamcinolone 2% | Procedure or surgery | control block, thoracic sympathetic block |
Primary outcome
Analgesia after block
Time frame: 1 month
Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
1 secondary outcome
analgesia quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
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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.
Roberto O Rocha, MD principal investigator
Hospital das Clinicas Faculty of Medicine University Sao Paulo
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 thoracic sympathetic block in people with Complex Regional Pain Syndrome I of Upper Limb, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 6 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 5 Jun 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 Brazil. 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?
Contact Roberto O Rocha, MD (551182668553, contato@drrobertorocha.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia after block (time frame: 1 month). 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 5 Jun 2012.