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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 because the information has not been verified recently.
Verified June 2012 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Analgesia after block [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.


Secondary Outcome Measures:
  • analgesia quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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:
  • T2-T3 thoracic sympathetic block
  • T3 sympathetic block
  • T2-T3 thoracic dorsal sympathetic block
  • thoracic sympathetic ganglion block
  • thoracic sympathetic block
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:
  • T2-T3 thoracic sympathetic block
  • T3 sympathetic block
  • T2-T3 thoracic dorsal sympathetic block
  • thoracic sympathetic ganglion block
  • thoracic sympathetic block

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

No publications provided

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
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
CRPS I

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Autonomic Nervous System Diseases
 Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on March 03, 2015