Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Complex Regional Pain Syndromes, CRPS

Intervention / Treatment
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* Drug: Delta9-Tetrahydrocannabinol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Delta9-Tetrahydrocannabinol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THC, CRPS, Pain, Complex Regional Pain Syndrome, Neuropathic Pain, Chronic, Prevention