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

Complex Regional Pain Syndrome I of Upper Limb Clinical Trial

Official title:

Double-Blind Randomized Controlled Trial: Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01612364
• Other study ID #: 5138 - 1805142/1
• Status: Recruiting
• Phase: Phase 3
• First received: May 30, 2012
• Last updated: June 1, 2012
• Start date: January 2010
• Est. completion date: November 2013

Study information

• Verified date: June 2012
• Source: University of Sao Paulo
• Contact: Roberto O Rocha, MD
• Phone: 551182668553
• Email: contato[@]drrobertorocha.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complex Regional Pain Syndrome I of Upper Limb
• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

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%

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia after block	Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.	1 month	No
Secondary	analgesia quality of life		1 year	No