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Terminated
NCT00891397
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)
Conditions: Complex Regional Pain Syndromes
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 14
Sponsor: McMaster University
Location: Hamilton General Hospital Hamilton Ontario
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Patients diagnosed with CRPS Type I as per the IASP (International Association for the Study of Pain) criteria which states presence of an initiating noxious event, or cause for immobilization
* Evidence at some point of swelling, color change, hot/cold/sweaty sensation and no other condition which can account for the pain and dysfunction of the upper limb
* Men or women between ages 18-65 year old
* Women should not be pregnant or breast feeding
* No change in treatment for 4 weeks prior to recruitment
* Pain scores of 4/10 on a verbal analogue scale
Exclusion Criteria:
* Patients with a neurologic disorder unrelated to CRPS
* Patients who are already on pregabalin
* Patients with renal impairment whose creatinine clearance is less than 60 ml/min
* Patients with congestive heart failure who are also diabetic and taking thiazolidinedione medication like rivoglitazone
* Unstable psychiatric history
* Patients with another problem with equal or worse pain
* Unstable medical condition
Source: ClinicalTrials.gov (NCT00891397). StuddyBuddy aggregates publicly available trial information.