Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II)
Recruitment status was: Recruiting
|CRPS Type II||Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Surgical Treatment of Complex Regional Pain Syndrome Type II (CRPS II) by Regional Subcutaneous Venous Sympathectomy|
- 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. [ Time Frame: 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.
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Patients with CRPS Type II
Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)
After incision of the skin a subcutaneous area of approximately 16 cm² (2.5 square inches) will be en block removed between dermis and muscle fascia. All prior detected and marked veins in the operating field will be ligated or coagulated precisely.The tissue defect generated by this operation will be closed by a full thickness or a meshed skin graft which arises during the preparation.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392599
|Contact: Wolfgang Happak, Prof., MDfirstname.lastname@example.org|
|Contact: Lukas K Kriechbaumer, MDemail@example.com|
|Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Wolfgang Happak, Prof., MD 0043140400 ext 6980 firstname.lastname@example.org|
|Principal Investigator: Wolfgang Happak, Prof., MD|
|Principal Investigator:||Wolfgang Happak, Prof. MD||Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna, Austria|