Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)
Recruitment status was Recruiting
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.
Complex Regional Pain Syndromes
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Prevention
|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|
- 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
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||December 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|