Status:
WITHDRAWN
Single-port Thoracoscopic Sympathicotomy in Complex Regional Pain Syndrome Type I (CRPS)
Lead Sponsor:
University of Groningen
Conditions:
Complex Regional Pain Syndrome Type I of the Upper Limb
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Background of the study: CRPS type-1 is a pain syndrome that usually develops after an initiating noxious event (e.g. fracture) in an extremity. Although treatment options life dimethyl-sulphoxide (DM...
Eligibility Criteria
Inclusion
- Age 18 - 65 years.
- ASA 1 en 2.
- CRPS-1 defined according to IASP-Bruehl criteria at the wrist or lower arm level.
- Continuing pain which is disproportionate to any inciting event
- Must report at least one symptom in each of the four following categories
- Sensory: reports of hyperesthesia
- Vasomotor: reports of temperature asymmetry, skin color change or asymmetry.
- Sudomotor/edema: reports of edema, sweating changes, sweating asymmetry
- Motor/trophic: reports of decreased range of motion, motor dysfunction (weakness, tremor, dystonia), trophic changes (hair, nail, skin)
- Must display at least one sign in two or more of the following categories:
- Sensory: evidence of hyperalgesia (to pinprick) and/or allodynia (to light touch)
- Vasomotor: evidence of temperature asymmetry, color changes, asymmetry
- Sudomotor/edema: evidence of edema, sweating changes, sweating asymmetry
- Motor/trophic: evidence of decreased range of motion, motor dysfunction (weakness, tremor, dystonia), trophic changes (hair, nail, skin)
Exclusion
- Known COPD \> Gold class 1.
- History of smoking \> 20 pack years, due to higher risk of complications following unilateral lung- deflation and re-insufflation.
- Documented substance addiction.
- Previous intra-thoracic pleural drainage on affected side.
- Previous thoracic surgery on affected side (including sternotomy). - Gross pulmonary or pleural abnormalities on chest X-ray.
- Pregnancy, determined by preoperative pregnancy test.
- Unsuitable anatomy (e.g. due to severe physical malformations).
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01886625
Start Date
August 1 2015
End Date
February 1 2017
Last Update
February 9 2016
Active Locations (1)
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1
University Medical Centre Groningen
Groningen, Provincie Groningen, Netherlands, 9700