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

May 30, 2012
June 1, 2012
January 2010
November 2013   (final data collection date for primary outcome measure)
Analgesia after block [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
Same as current
Complete list of historical versions of study NCT01612364 on ClinicalTrials.gov Archive Site
analgesia quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Complex Regional Pain Syndrome I of Upper Limb
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Roberto O Rocha, MD 551182668553 contato@drrobertorocha.com.br
Brazil
 
NCT01612364
5138 - 1805142/1
Yes
Roberto O Rocha, University of Sao Paulo
University of Sao Paulo
University of Sao Paulo General Hospital
Principal Investigator: Roberto O Rocha, MD Hospital das Clinicas Faculty of Medicine University Sao Paulo
University of Sao Paulo
June 2012

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