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RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb

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ClinicalTrials.gov Identifier: NCT01612364
Recruitment Status : Unknown
Verified June 2012 by Roberto O Rocha, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : June 5, 2012
Last Update Posted : June 5, 2012
Sponsor:
Collaborator:
University of Sao Paulo General Hospital
Information provided by (Responsible Party):
Roberto O Rocha, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE May 30, 2012
First Posted Date  ICMJE June 5, 2012
Last Update Posted Date June 5, 2012
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2012)
Analgesia after block [ Time Frame: 1 month ]
Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2012)
analgesia quality of life [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
Official Title  ICMJE Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
Brief 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 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Complex Regional Pain Syndrome I of Upper Limb
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: thoracic sympathetic block
    Sympathetic block of upper limb via thoracic vertebra T3
    Intervention: Procedure: thoracic sympathetic block
  • Active Comparator: control block
    Same medication used in experimental group, but in dorsal subcutaneous
    Intervention: Procedure: thoracic sympathetic block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 1, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2013
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01612364
Other Study ID Numbers  ICMJE 5138 - 1805142/1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roberto O Rocha, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE University of Sao Paulo General Hospital
Investigators  ICMJE
Principal Investigator: Roberto O Rocha, MD Hospital das Clinicas Faculty of Medicine University Sao Paulo
PRS Account University of Sao Paulo
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP