idocaine medicated plaster in patients with CRPS
- Conditions
- Complex Regional Pain Syndrome - CRPS lasting longer than 6 monthTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-002212-81-AT
- Lead Sponsor
- Klinik für Physikalische Medizin und Rehabilitation, Medizinische Universität Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
CRPS typ I of the upper limb, lasting longer than 6 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
thrombosis, inflammation, edema, severe dysfunction of the heart, liver and kidney, pregnancy, diabetic neuropathia, peripheral lesion of the nervous system, diseases of the central nervous system, diseases of the contralateral arm, contraindication to the physical therapy, allergy or hypersensitivity to the lidocaine-patch
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does a Lidocaine medicated plaster in combination with physical therapy increase the armfunction (Radboud skills questionnaire) and normalize armtemperature (infra-red thermography) in patients with CRPS. ;Secondary Objective: Pain, allodynia, sensory dysfunctions;Primary end point(s): Radboud skills questionnaire, infra-red thermography;Timepoint(s) of evaluation of this end point: week 0, week 5, week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): pain, allodynia, sensory disturbancies;Timepoint(s) of evaluation of this end point: week 0, week 5, week 12