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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra-CT: 2006-000439-85 |
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| German Research Network on Neuropathic Pain | NETWORK |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delta9-Tetrahydrocannabinol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meike Lauchart, MD | Contact | +49897095 | 4464 | Meike.Lauchart@med.uni-muenchen.de |
| Volker Huge, MD | Contact | +49897095 | 4464 | Volker.Huge@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Shahnaz C Azad, MD;PhD | Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich | Recruiting | Munich | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16697110 | Background | Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner 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):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11. | |
| 15525780 |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D010146 | Pain |
| D009437 | Neuralgia |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| 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 |
| Background |
| Azad SC, Monory K, Marsicano G, Cravatt BF, Lutz B, Zieglgansberger W, Rammes G. Circuitry for associative plasticity in the amygdala involves endocannabinoid signaling. J Neurosci. 2004 Nov 3;24(44):9953-61. doi: 10.1523/JNEUROSCI.2134-04.2004. |
| 12663750 | Background | Azad SC, Eder M, Marsicano G, Lutz B, Zieglgansberger 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. doi: 10.1101/lm.53303. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |