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

Phase 3

• Conditions: Complex Regional Pain Syndrome I of Upper Limb
• Interventions: Procedure: thoracic sympathetic block

• Registration Number: NCT01612364
• Lead Sponsor: University of Sao Paulo

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-05-30
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-01
• Last Update Submitted: 2012-06-01
• Study First Posted: 2012-06-05
• Last Update Posted: 2012-06-05
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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) -

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thoracic sympathetic block	thoracic sympathetic block	Sympathetic block of upper limb via thoracic vertebra T3
control block	thoracic sympathetic block	Same medication used in experimental group, but in dorsal subcutaneous

Primary Outcome Measures

Name	Time	Method
Analgesia after block	1 month	Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.

Secondary Outcome Measures

Name	Time	Method
analgesia quality of life	1 year

Trial Locations

Locations (1)

Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil