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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Complex Regional Pain Syndrome I of Upper Limb	Procedure: thoracic sympathetic block	Phase 3

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (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
Study Start Date :	January 2010
Estimated Primary Completion Date :	November 2013
Estimated Study Completion Date :	November 2013

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Analgesia after block [ Time Frame: 1 month ]
   Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.

Secondary Outcome Measures :

1. analgesia quality of life [ Time Frame: 1 year ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	June 5, 2012
Last Update Posted:	June 5, 2012
Last Verified:	June 2012

Keywords provided by Roberto O Rocha, 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