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

Primary Purpose

CRPS Type II

Status
Unknown status
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CRPS Type II focused on measuring CRPS Type II, Pain, Surgery, Regional Subcutaneous Venous Sympathectomy(RSVS), Sudeck, Reflex sympathetic dystrophy (RSD), Causalgia, Algodystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery

Arm Description

Patients with CRPS Type II

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2011
Last Updated
July 11, 2011
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01392599
Brief Title
Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II)
Official Title
Surgical Treatment of Complex Regional Pain Syndrome Type II (CRPS II) by Regional Subcutaneous Venous Sympathectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CRPS Type II
Keywords
CRPS Type II, Pain, Surgery, Regional Subcutaneous Venous Sympathectomy(RSVS), Sudeck, Reflex sympathetic dystrophy (RSD), Causalgia, Algodystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Experimental
Arm Description
Patients with CRPS Type II
Intervention Type
Procedure
Intervention Name(s)
SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Outcome measures will be evaluated at baseline and 6 weeks after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfgang Happak, Prof., MD
Phone
00431404006980
Email
lukikriechbaumer@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lukas K Kriechbaumer, MD
Phone
00431404007177
Email
lukas.kriechbaumer@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfgang Happak, Prof. MD
Organizational Affiliation
Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Happak, Prof., MD
Phone
0043140400
Ext
6980
Email
lukikriechbaumer@hotmail.com
First Name & Middle Initial & Last Name & Degree
Wolfgang Happak, Prof., MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
10353502
Citation
Bruehl S, Harden RN, Galer BS, Saltz S, Bertram M, Backonja M, Gayles R, Rudin N, Bhugra MK, Stanton-Hicks M. External validation of IASP diagnostic criteria for Complex Regional Pain Syndrome and proposed research diagnostic criteria. International Association for the Study of Pain. Pain. 1999 May;81(1-2):147-54. doi: 10.1016/s0304-3959(99)00011-1.
Results Reference
background
PubMed Identifier
16427199
Citation
Albrecht PJ, Hines S, Eisenberg E, Pud D, Finlay DR, Connolly KM, Pare M, Davar G, Rice FL. Pathologic alterations of cutaneous innervation and vasculature in affected limbs from patients with complex regional pain syndrome. Pain. 2006 Feb;120(3):244-266. doi: 10.1016/j.pain.2005.10.035. Epub 2006 Jan 19.
Results Reference
background
PubMed Identifier
16427737
Citation
Oaklander AL, Rissmiller JG, Gelman LB, Zheng L, Chang Y, Gott R. Evidence of focal small-fiber axonal degeneration in complex regional pain syndrome-I (reflex sympathetic dystrophy). Pain. 2006 Feb;120(3):235-243. doi: 10.1016/j.pain.2005.09.036. Epub 2006 Jan 19.
Results Reference
background
PubMed Identifier
8383935
Citation
Arnold JM, Teasell RW, MacLeod AP, Brown JE, Carruthers SG. Increased venous alpha-adrenoceptor responsiveness in patients with reflex sympathetic dystrophy. Ann Intern Med. 1993 Apr 15;118(8):619-21. doi: 10.7326/0003-4819-118-8-199304150-00008. No abstract available.
Results Reference
background
PubMed Identifier
12020526
Citation
Baron R, Schattschneider J, Binder A, Siebrecht D, Wasner G. Relation between sympathetic vasoconstrictor activity and pain and hyperalgesia in complex regional pain syndromes: a case-control study. Lancet. 2002 May 11;359(9318):1655-60. doi: 10.1016/S0140-6736(02)08589-6.
Results Reference
background
PubMed Identifier
1933231
Citation
Drummond PD, Finch PM, Smythe GA. Reflex sympathetic dystrophy: the significance of differing plasma catecholamine concentrations in affected and unaffected limbs. Brain. 1991 Oct;114 ( Pt 5):2025-36. doi: 10.1093/brain/114.5.2025.
Results Reference
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Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II)

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