Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II)

CRPS Type II Clinical Trial

Official title: Surgical Treatment of Complex Regional Pain Syndrome Type II (CRPS II) by Regional Subcutaneous Venous Sympathectomy

Status Recruiting

Clinical Trial Summary

The purpose of this study is to investigated and evaluated the effectiveness of a new surgical technique for the treatment of severe chronic pain stages (Complex Regional Pain Syndrome Type II).

Clinical Trial Description

For 140 years the treatment of Complex Regional Pain Syndromes Type II (CRPS II) has been an unsolved problem. Recent findings in animal models assume that CRPS Type II is maintained by a coupling of newly sprouted sympathetic and sensible fibres. Therapeutic approaches have included conventional pain medication, physical therapy, sympathetic blocks, transcutaneous or spinal cord stimulation, injections or infusion therapies and sympathectomy. Alone or in combination these therapies often yielded unfavorable results. The majority of physicians dealing with CRPS patients are convinced that a surgical treatment of the affected extremity only exacerbates the symptoms, especially its hallmark excruciating pain.

Patients with a CRPS Type II at the upper or the lower limb will be included in the study after ineffective pain therapy for more than 6 months. The most proximal region of pain associated with CRPS can be localized and 2% Lidocain will be injected into that area. If the sympathetic, deep, burning pain can be blocked repeatedly with these injections, the subcutaneous veins in the previously determined area will be surgically removed. This operation should lead to the permanent resolution of symptoms.

A visual analogue scale (VAS), the Nottingham Health Profile (NHP), thermography and physical examinations will be used to evaluate the outcome of the operation. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Causalgia
• Complex Regional Pain Syndromes
• CRPS Type II
• Reflex Sympathetic Dystrophy

• NCT number: NCT01392599
• Study type: Interventional
• Source: Medical University of Vienna
• Contact: Wolfgang Happak, Prof., MD
• Phone: 00431404006980
• Email: lukikriechbaumer@hotmail.com
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2009
• Completion date: October 2013