Pregabalin Versus Placebo as an Add on for Complex Regional Pain Syndrome (CPRS) of the Upper Limb Managed by Stellate Ganglion Block (The PREGA Study)
The purpose of this study is to assess the efficacy of pregabalin in patients with complex regional pain syndrome Type I and to determine whether it provides clinically significant pain relief and whether it improves functioning of the upper limb.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pregabalin vs. Placebo as an Add on for Complex Regional Pain Syndrome of the Upper Limb Managed by Stellate Ganglion Block|
- Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly. [ Time Frame: Three months ] [ Designated as safety issue: No ]
- Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form. [ Time Frame: Three months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Study Completion Date:||October 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Pregabalin group is made up of 20 patients. Patients will receive 150mg/day in two divided does. The patients will be assessed weekly and the dose can be increased to 300mg/day, if the patient does not report any decrease in pain. The following week the dose may be increased to 600mg/day if once again the patient reports no decrease in pain. This is also the maximum permissible does that will be given to the patient. If patient reports any side effects then the dose can be decreased once. The time period of 2 to 5 weeks will be the dose adjustment period. After which the drug maintenance period extends from week 5 to 12. All doses will be given in two divided doses/day.
Dose of 150mg/day divided in two doses. Increased to 300mg/day then to 600mg/day, always divided in two doses for the day.
Other Name: Lyrica
Placebo Comparator: 2
Ten patients will be be in the placebo group.
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Norman Buckley, MD||Hamilton Health Sciences Corporation|