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

Phase 3

• Conditions: CRPS Type II
• Interventions: Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)

• Registration Number: NCT01392599
• Lead Sponsor: Medical University of Vienna

Brief 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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-01
• Status Verified: 2011-06
• Study First Submitted: 2011-06-30
• Study First Submitted QC: 2011-07-11
• Last Update Submitted: 2011-07-11
• Study First Posted: 2011-07-12
• Last Update Posted: 2011-07-12
• Primary Completion: 2013-01
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients suffering from CRPS Type II after after ineffective pain therapy for more than 6 months.

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Exclusion Criteria

• Ineffective testinfiltration with an local anesthetic Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)	Patients with CRPS Type II

Primary Outcome Measures

Name	Time	Method
Enhancement in the quality of life (measured by the NHP) due to a permanent reduction of pain (measured by the NHP and a VAS) of patients suffering from CRPS Type II.	Outcome measures will be evaluated at baseline and 6 weeks after the operation	An appraisal of results will be made after the operation by using physical examionations and the standardized questionnaires (NHP,VAS). The health status and especially the pain level have to be constant for at least 3 month before being considered as an result.

Trial Locations

Locations (1)

Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna; 🇦🇹 Vienna, Austria