Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)
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|ClinicalTrials.gov Identifier: NCT00377468|
Recruitment Status : Unknown
Verified June 2008 by Ludwig-Maximilians - University of Munich.
Recruitment status was: Recruiting
First Posted : September 18, 2006
Last Update Posted : June 30, 2008
|Condition or disease||Intervention/treatment||Phase|
|Complex Regional Pain Syndromes CRPS||Drug: Delta9-Tetrahydrocannabinol||Phase 2|
Recent animal data suggest that the endocannabinoid system is a promising target in the prevention of chronic pain. It has been shown that the endocannabinoid system modifies excitatory and inhibitory currents in structures involved in the development of chronic pain such as the amygdala.
CRPS is a neuropathic pain condition, which is known to become chronic in a significant percentage. The study compares the effect of low dose Delta9-Tetrahydrocannabinol (90 days) and placebo in acute CRPS. All patients will receive a standard treatment consisting of drug therapy and physiotherapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Factorial Assignment|
|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|
|Study Start Date :||September 2006|
|Estimated Study Completion Date :||December 2008|
- Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)
- Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)
- Motor function of the affected extremity at one year assessed with a biometric evaluation
- Changes in Health Related Quality of Life at one year assessed with SF-36
- Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377468
|Contact: Meike Lauchart, MD||+49897095 ext 4464||Meike.Lauchart@med.uni-muenchen.de|
|Contact: Volker Huge, MD||+49897095 ext 4464||Volker.Huge@med.uni-muenchen.de|
|Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich||Recruiting|
|Munich, Germany, 81377|
|Principal Investigator:||Shahnaz C Azad, MD;PhD||Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich|