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

NCT01392599 | Unknown Phase 3

• 1 other identifier: 026/2009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

CRPS Type II

Keywords

CRPS Type II; Pain; Surgery; Regional Subcutaneous Venous Sympathectomy(RSVS); Sudeck; Reflex sympathetic dystrophy (RSD); Causalgia; Algodystrophy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Surgery

EXPERIMENTAL

Patients with CRPS Type II

Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)

Interventions

SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS) PROCEDURE

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.

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Ineffective testinfiltration with an local anesthetic Pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Related Publications (6)

• 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.

  PMID: 10353502 BACKGROUND

• 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.

  PMID: 16427199 BACKGROUND

• 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.

  PMID: 16427737 BACKGROUND

• 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.

  PMID: 8383935 BACKGROUND

• 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.

  PMID: 12020526 BACKGROUND

• 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.

  PMID: 1933231 BACKGROUND

MeSH Terms

Conditions

Causalgia; Pain; Reflex Sympathetic Dystrophy

Condition Hierarchy (Ancestors)

Complex Regional Pain Syndromes; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neuralgia; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wolfgang Happak, Prof. MD

  Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna, Austria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Happak, Prof., MD

CONTACT

00431404006980; lukikriechbaumer@hotmail.com

Lukas K Kriechbaumer, MD

CONTACT

00431404007177; lukas.kriechbaumer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 12, 2011
• Study Start: January 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 12, 2011

Record last verified: 2011-06

Locations

AU (1)