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

Primary Purpose

Complex Regional Pain Syndromes, CRPS

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Delta9-Tetrahydrocannabinol

About this trial

This is an interventional prevention trial for Complex Regional Pain Syndromes focused on measuring THC, CRPS, Pain, Complex Regional Pain Syndrome, Neuropathic Pain, Chronic, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of MunichRecruiting

Outcomes

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

Full Information

NCT ID

NCT00377468

First Posted

September 14, 2006

Last Updated

June 26, 2008

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

German Federal Ministry of Education and Research, German Research Network on Neuropathic Pain

1. Study Identification

Unique Protocol Identification Number

NCT00377468

Brief Title

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

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Unknown status

Study Start Date

September 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

German Federal Ministry of Education and Research, German Research Network on Neuropathic Pain

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complex Regional Pain Syndromes, CRPS

Keywords

THC, CRPS, Pain, Complex Regional Pain Syndrome, Neuropathic Pain, Chronic, Prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

Double

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Delta9-Tetrahydrocannabinol

Primary Outcome Measure Information:

Title

Incidence of chronic pain at one year assessed with Visual Analogue Scale (VAS)

Secondary Outcome Measure Information:

Title

Changes in somatosensory phenotype at one year assessed with Quantitative Sensory Testing (QST)

Title

Motor function of the affected extremity at one year assessed with a biometric evaluation

Title

Changes in Health Related Quality of Life at one year assessed with SF-36

Title

Changes in plasma endocannabinoid levels at 30, 60, 90 days and at one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meike Lauchart, MD

Phone

+49897095

Ext

4464

Meike.Lauchart@med.uni-muenchen.de

First Name & Middle Initial & Last Name or Official Title & Degree

Volker Huge, MD

Phone

+49897095

Ext

4464

Volker.Huge@med.uni-muenchen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shahnaz C Azad, MD;PhD

Organizational Affiliation

Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, University of Munich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anesthesiology, Interdisciplinary Pain Clinic Grosshadern, Universitiy of Munich

City

Munich

ZIP/Postal Code

81377

Country

Germany

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

16697110

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. Erratum In: Pain. 2006 Nov;125(1-2):197.

Results Reference

background

PubMed Identifier

15525780

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.

Results Reference

background

PubMed Identifier

12663750

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.

Results Reference

background

Learn more about this trial

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

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