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

CRPS Type II Clinical Trial

Official title:

Surgical Treatment of Complex Regional Pain Syndrome Type II (CRPS II) by Regional Subcutaneous Venous Sympathectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01392599
• Other study ID #: 026/2009
• Status: Recruiting
• Phase: Phase 3
• First received: June 30, 2011
• Last updated: July 11, 2011
• Start date: January 2009
• Est. completion date: October 2013

Study information

• Verified date: June 2011
• Source: Medical University of Vienna
• Contact: Wolfgang Happak, Prof., MD
• Phone: 00431404006980
• Email: lukikriechbaumer[@]hotmail.com
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Causalgia
• Complex Regional Pain Syndromes
• CRPS Type II
• Reflex Sympathetic Dystrophy

Intervention

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.

Locations

Country	Name	City	State
Austria	Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (6)

Albrecht PJ, Hines S, Eisenberg E, Pud D, Finlay DR, Connolly MK, Paré 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):244-66. Epub 2006 Jan 19. — View 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. — View 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. — View 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. — View 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. — View 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):235-43. Epub 2006 Jan 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Outcome measures will be evaluated at baseline and 6 weeks after the operation	Yes