Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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 Design
Outcome Measures
Primary Outcome Measures
- Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS) []
Secondary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
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:
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History of alcohol or drug abuse
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Cardiac arrhythmias
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Acute or chronic renal failure
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ASA physical status classification III or higher
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Psychiatric disorders
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Pregnancy and breast feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich | Munich | Germany | 81377 |
Sponsors and Collaborators
- Ludwig-Maximilians - University of Munich
- German Federal Ministry of Education and Research
- German Research Network on Neuropathic Pain
Investigators
- Principal Investigator: Shahnaz C Azad, MD;PhD, Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Rolke R, Baron R, Maier C, Tölle TR, Treede -DR, 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):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11. Erratum in: Pain. 2006 Nov;125(1-2):197.
- 2310106
- Eudra-CT: 2006-000439-85