Complex Regional Pain Syndromes Clinical Trial
Official title:
Low Dose Administration of Delta9-Tetrahydrocannabinol for the Prevention of Hyperalgesia and Chronic Pain in Patients With Acute Complex Regional Pain Syndrome (CRPS) of the Upper Limb
The purpose of this study is to determine whether application of low dose Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with acute CRPS.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with clinical diagnosis of acute CRPS (time from inciting event less than 16 weeks) of the upper extremity - No risk of dependency in a psychological assessment Exclusion Criteria: - History of alcohol or drug abuse - Cardiac arrhythmias - Acute or chronic renal failure - ASA physical status classification III or higher - Psychiatric disorders - Pregnancy and breast feeding |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich | Munich |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich | German Federal Ministry of Education and Research, German Research Network on Neuropathic Pain |
Germany,
Azad SC, Eder M, Marsicano G, Lutz B, Zieglgänsberger W, Rammes G. Activation of the cannabinoid receptor type 1 decreases glutamatergic and GABAergic synaptic transmission in the lateral amygdala of the mouse. Learn Mem. 2003 Mar-Apr;10(2):116-28. — View Citation
Azad SC, Monory K, Marsicano G, Cravatt BF, Lutz B, Zieglgänsberger W, Rammes G. Circuitry for associative plasticity in the amygdala involves endocannabinoid signaling. J Neurosci. 2004 Nov 3;24(44):9953-61. — View Citation
Rolke R, Baron R, Maier C, Tölle TR, Treede RD, Beyer A, Binder A, Birbaumer N, Birklein F, Bötefür IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihöfner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-43. Epub 2006 May 11. Erratum in: Pain. 2006 Nov;125(1-2):197. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS) | |||
Secondary | Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST) | |||
Secondary | Motor function of the affected extremity at one year assessed with a biometric evaluation | |||
Secondary | Changes in Health Related Quality of Life at one year assessed with SF-36 | |||
Secondary | Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year |
Status | Clinical Trial | Phase | |
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