None listed
Conditions
Interventions
Subjects are assigned to receive either intrathecal 60 mg methylprednisolone acetate or placebo.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Patients will be male or female, outpatients aged 18 - 75 year, with a clinical diagnosis of CRPS who are referred to the LUMC . 1. At onset patients must fulfill the criteria for CRPS I. These criteria include the combination of continuing pain, allodynia or hyperalgesia, rendering the pain disproportionate to any inciting event, evidence at some time of edema, changes in skin blood flow, or abnormal sudomotor activity in the region of the pain, absence of a condition which would otherwise account for the degree of pain and dysfunction; 2. When entering the study patients must suffer from symptoms and signs indicative of central sensitization (continuing pain, hyperalgesia and/or allodynia); 3. Patients must have symptoms for more than 6 months and shorter than 6 years; 4. Use of pain medication must have been stable in the previous four weeks; 5. Patients must be willing and able to give informed consent according to the national requirements. 6. Patients must report spontaneous pain of at least 5 cm on a visual-analogue scale (0 cm represents no pain, 10 cm represents the worst imaginable pain).
Exclusion criteria
Exclusion criteria: 1. Patients are excluded if they can obtain satisfactory relief of symptoms with conventional treatments such as NSAIDs or paracetamol; 2. Patients using oral anticoagulant medication or having an impaired blood coagulation for other reasons; 3. Patients suffering from diabetes mellitus; 4. Patients with an immunocompromised state; 5. Patients with an acute infection; 6. Patients with an intracranial space occupying lesion; 7. Patients with a thrombocytopenia of less than 50x109/L; 8. Patients with clinically significant psychiatric illness; 9. Patients who have a history of alcohol or drug abuse within the past year; 10. Patients with a known hypersensitivity to (methyl)prednisolone; 11. Patients who are unlikely to comply with study requirements or have a history of poor compliance to medical regimens or study requirements; 12. Patients who have received an experimental treatment within the last month; 13. Pregnant, nursing women and females of childbearing potential not using oral contraceptives or a medically recognised mechanical means of contraception; 14. Patients involved in legal proceedings (claiming compensation for the CRPS I).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The severity of spontaneous pain is evaluated through a 10 cm visual-analogue scale (0 cm represents no pain, 10 cm represents the worst imaginable pain). This will be filled in at home in a diary. Primary outcome is pain relief at 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.. Sensory assessments 1.1 The nature of the pain is assessed by means of the neuropathic pain scale developed by Galer which consists of several visual analogue scales for different kinds of pain. Also a Mc Gill Pain Questionnaire will be administered; 1.2 Hyper- and hypoesthesia and allodynia will be tested using Von Frey hairs; 1.3 Pain and temperature perception thresholds (Temperature Sensory Assessment using the Medoc TSA II Neurosensory Analyser). A thermode will be placed on the volar side of the wrist or dorsal side of the foot; 1.4 Somatosensory evoked potentials; 2. Autonomic assessments 2.1 Skin temperature of affected and contralateral extremity and midsternal; 2.2 The difference in volume between the affected and contralateral extremity is assessed by a volumeter as a measure for edema. This instrument measures the amount of water that is displaced by the immersed body part; 2.3 Pulse transit time (the time the pulse wave takes to travel from heart to finger) as a measure of peripheral vessel resistance; 3. Motor assessments 3.1 Patients will be evaluated for the presence and severity dystonia, myoclonus and tremor (none, intermittent, continuous); 3.2 Range of motion will be assessed using a universal goniometer; 3.3 In those patients in which this can be evaluated, movement velocity of repetitive fingertaps will be objectively quantified; 3.4 In those patients in which this can be evaluated, proprioceptive reflexes will be assessed using a wrist pertubator; 4. Disability 4.1 Patients will be asked to mark the change in function of the affected hand or foot on a scale from 1 to 7 (1=maximal worse, 4=no change, 7=maximal better); 4.2 Radboud skills questionnaire, walking stairs questionnaire and questionnaire rising and sitting down will be administered; 4.3 Participation and global health will be assessed using the short form (SF)-36; 4.4 questionnaire, EuroQol 5D, Inventarisatielijst Sociale Betrekkingen (ISB) and Impact o | — |
Contacts
Public ContactJ.J. Hilten, van
Leiden University Medical Center (LUMC), Department of Neurology, Postzone K-05Q, P.O. Box 9600
Outcome results
None listed