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)

Not Applicable

Terminated

• Conditions: Complex Regional Pain Syndromes
• Interventions: Other: Placebo; Drug: Pregabalin

• Registration Number: NCT00891397
• Lead Sponsor: McMaster University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2010-01
• Study Completion: 2010-10
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Ten patients will be be in the placebo group.
1	Pregabalin	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.

Primary Outcome Measures

Name	Time	Method
Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly.	Three months

Secondary Outcome Measures

Name	Time	Method
Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form.	Three months

Trial Locations

Locations (1)

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada