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

Medical University of Vienna

Status and phase: Unknown; Phase 3

Conditions: CRPS Type II

Treatments: Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01392599

026/2009

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Ineffective testinfiltration with an local anesthetic Pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Surgery

Experimental group

Description:

Patients with CRPS Type II

Treatment:

Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)