RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by University of Sao Paulo.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University of Sao Paulo
Collaborator:
University of Sao Paulo General Hospital
Information provided by (Responsible Party):
Roberto O Rocha, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01612364
First received: May 30, 2012
Last updated: June 1, 2012
Last verified: June 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Complex Regional Pain Syndrome I of Upper Limb |
Procedure: thoracic sympathetic block |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- Analgesia after block [ Time Frame: 1 month ]Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
Secondary Outcome Measures:
- analgesia quality of life [ Time Frame: 1 year ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: thoracic sympathetic block
Sympathetic block of upper limb via thoracic vertebra T3
|
Procedure: thoracic sympathetic 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%
Other Names:
|
|
Active Comparator: control block
Same medication used in experimental group, but in dorsal subcutaneous
|
Procedure: thoracic sympathetic 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%
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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) -
Exclusion Criteria:
- 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612364
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612364
Contacts
| Contact: Roberto O Rocha, MD | 551182668553 | contato@drrobertorocha.com.br |
Locations
| Brazil | |
| Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo | Recruiting |
| Sao Paulo, Brazil, 05403000 | |
| Contact: Roberto O Rocha, MD 5511 82668553 contato@drrobertorocha.com.br | |
| Principal Investigator: Roberto O Rocha, MD | |
Sponsors and Collaborators
University of Sao Paulo
University of Sao Paulo General Hospital
Investigators
| Principal Investigator: | Roberto O Rocha, MD | Hospital das Clinicas Faculty of Medicine University Sao Paulo |
More Information
| Responsible Party: | Roberto O Rocha, MD, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01612364 History of Changes |
| Other Study ID Numbers: |
5138 - 1805142/1 |
| Study First Received: | May 30, 2012 |
| Last Updated: | June 1, 2012 |
Keywords provided by University of Sao Paulo:
|
CRPS I |
Additional relevant MeSH terms:
|
Syndrome Somatoform Disorders Complex Regional Pain Syndromes Reflex Sympathetic Dystrophy Disease Pathologic Processes |
Mental Disorders Autonomic Nervous System Diseases Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases |
ClinicalTrials.gov processed this record on May 24, 2017