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)
Information source: McMaster University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complex Regional Pain Syndromes
Intervention: Pregabalin (Drug); Placebo (Other)
Phase: N/A
Status: Terminated
Sponsored by: McMaster University Official(s) and/or principal investigator(s): Norman Buckley, MD, Principal Investigator, Affiliation: Hamilton Health Sciences Corporation
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.
Clinical Details
Official title: Pregabalin vs. Placebo as an Add on for Complex Regional Pain Syndrome of the Upper Limb Managed by Stellate Ganglion Block
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly.
Secondary outcome: Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Hamilton General Hospital, Hamilton, Ontario L8L 2X2, Canada
Additional Information
Related publications: Freynhagen R, Strojek K, Griesing T, Whalen E, Balkenohl M. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain. 2005 Jun;115(3):254-63. Epub 2005 Apr 18.
Starting date: November 2007
Last updated: April 7, 2015
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