Overview

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