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).

Study Overview

• Status: Unknown
• Conditions: Complex Regional Pain Syndrome I of Upper Limb
• Intervention / Treatment: Procedure: thoracic sympathetic block

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Roberto O Rocha, MD; Phone Number: 551182668553; Email: contato@drrobertorocha.com.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403000
    • Recruiting
    • Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo
    • Contact: Roberto O Rocha, MD; Phone Number: 5511 82668553; Email: contato@drrobertorocha.com.br
    • Principal Investigator: Roberto O Rocha, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia after block	Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
analgesia quality of life	1 year

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Roberto O Rocha, MD, Hospital das Clinicas Faculty of Medicine University Sao Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): November 1, 2013
• Study Completion (Anticipated): November 1, 2013

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Estimate): June 5, 2012
• Last Update Submitted That Met QC Criteria: June 1, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: CRPS I
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: 5138 - 1805142/1