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)

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborators: Hamilton Health Sciences Corporation; Pfizer
• Treatments: Pregabalin

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