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

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Complex Regional Pain Syndrome I of Upper Limb

Intervention: thoracic sympathetic block (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Sao Paulo

Official(s) and/or principal investigator(s):
Roberto O Rocha, MD, Principal Investigator, Affiliation: Hospital das Clinicas Faculty of Medicine University Sao Paulo

Overall contact:
Roberto O Rocha, MD, Phone: 551182668553, Email: contato@drrobertorocha.com.br

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).

Clinical Details

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

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

Primary outcome: Analgesia after block

Secondary outcome: analgesia quality of life

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Roberto O Rocha, MD, Phone: 551182668553, Email: contato@drrobertorocha.com.br

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

Starting date: January 2010
Last updated: June 1, 2012

Page last updated: August 23, 2015

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