CRPS Type IIPhase 3NCT01392599
Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II)
A Phase 3 study testing SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS) in people with CRPS Type II, run by Medical University of Vienna at 1 site in Austria.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRPS Type II
- What is being tested?
- SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2009to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from CRPS Type II after after ineffective pain therapy for more than 6 months.
Who cannot join
- Ineffective testinfiltration with an local anesthetic Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna
Vienna, State of Vienna, 1090
Wolfgang Happak, Prof., MD, 0043140400 ext. 6980, lukikriechbaumer@hotmail.com
Wolfgang Happak, Prof., MD
About this study
Official title: Surgical Treatment of Complex Regional Pain Syndrome Type II (CRPS II) by Regional Subcutaneous Venous Sympathectomy
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).
Read the 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.
- Conditions
- CRPS Type II
- Being tested
- SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)
- Keywords
- CRPS Type II, Pain, Surgery, Regional Subcutaneous Venous Sympathectomy(RSVS), Sudeck, Reflex sympathetic dystrophy (RSD), Causalgia, Algodystrophy
- Medical subject headings
- Causalgia, Pain, Reflex Sympathetic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Patients with CRPS Type II Receives: Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Outcome measures will be evaluated at baseline and 6 weeks after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJan 2009
- Primary completionJan 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CRPS Type IIStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Wolfgang Happak, Prof. MD, Principal investigator, Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392599
- Sponsor's protocol ID
- 026/2009
- Status last verified
- Jun 2011
- First submitted
- 30 Jun 2011
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10353502Albrecht 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.
PubMed 16427199Oaklander 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.
PubMed 16427737Arnold 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.
PubMed 8383935Baron 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.
PubMed 12020526Drummond 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.
PubMed 1933231
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Complex Regional Pain Syndrome Type II (CRPS II) by Regional Subcutaneous Venous Sympathectomy
- ClinicalTrials.gov ID
- NCT01392599
- Acronym / sponsor ID
- 026/2009
- Conditions
- CRPS Type II
- Keywords
- CRPS Type II, Pain, Surgery, Regional Subcutaneous Venous Sympathectomy(RSVS), Sudeck, Reflex sympathetic dystrophy (RSD), Causalgia, Algodystrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)Patients with CRPS Type II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients suffering from CRPS Type II after after ineffective pain therapy for more than 6 months.
Key exclusion criteria (1 listed)
- Ineffective testinfiltration with an local anesthetic Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Surgery |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
- Background: PubMed 10353502Bruehl 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.
- Background: PubMed 16427199Albrecht 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.
- Background: PubMed 16427737Oaklander 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.
- Background: PubMed 8383935Arnold 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.
- Background: PubMed 12020526Baron 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.
- Background: PubMed 1933231Drummond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Happak, Prof. MD principal investigator
Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS) in people with CRPS Type II, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Happak, Prof., MD (00431404006980, lukikriechbaumer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01392599, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.