Clinical trial NCT00377468: Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Complex Regional Pain Syndromes
CRPS
Keywords: THC
CRPS
Pain
Complex Regional Pain Syndrome
Neuropathic Pain
Chronic
Prevention
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: German Research Network on Neuropathic Pain
First posted: 2006-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)
Secondary outcomes:
measure: Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)
measure: Motor function of the affected extremity at one year assessed with a biometric evaluation
measure: Changes in Health Related Quality of Life at one year assessed with SF-36
measure: Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich
Study officials:
affiliation: Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich
name: Shahnaz C Azad, MD;PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.