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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01392599
First received: June 30, 2011
Last updated: July 11, 2011
Last verified: June 2011
  Purpose

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).


Condition Intervention Phase
CRPS Type II
Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
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)
Arms Assigned Interventions
Experimental: Surgery
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392599

Contacts
Contact: Wolfgang Happak, Prof., MD 00431404006980 lukikriechbaumer@hotmail.com
Contact: Lukas K Kriechbaumer, MD 00431404007177 lukas.kriechbaumer@meduniwien.ac.at

Locations
Austria
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    lukikriechbaumer@hotmail.com   
Principal Investigator: Wolfgang Happak, Prof., MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Wolfgang Happak, Prof. MD Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna, Austria
  More Information

Publications:
Responsible Party: Wolfgang Happak, Prof. MD, Division of Plastic and Reconstructive Surgery, Surgical Clinic, Medical University of Vienna, Austria
ClinicalTrials.gov Identifier: NCT01392599     History of Changes
Other Study ID Numbers: 026/2009
Study First Received: June 30, 2011
Last Updated: July 11, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
CRPS Type II
Pain
Surgery
Regional Subcutaneous Venous Sympathectomy(RSVS)
Sudeck
Reflex sympathetic dystrophy (RSD)
Causalgia
Algodystrophy

Additional relevant MeSH terms:
Causalgia
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuralgia

ClinicalTrials.gov processed this record on August 18, 2014