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

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: November 2013

Interventions

  • 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%

Arms, Groups and Cohorts

  • Experimental: thoracic sympathetic block
    • Sympathetic block of upper limb via thoracic vertebra T3
  • Active Comparator: control block
    • Same medication used in experimental group, but in dorsal subcutaneous

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • analgesia quality of life
    • Time Frame: 1 year

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Collaborator
    • University of Sao Paulo General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Roberto O Rocha, MD – University of Sao Paulo
  • Overall Official(s)
    • Roberto O Rocha, MD, Principal Investigator, Hospital das Clinicas Faculty of Medicine University Sao Paulo
  • Overall Contact(s)
    • Roberto O Rocha, MD, 551182668553, contato@drrobertorocha.com.br

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