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)

Complex Regional Pain Syndromes Clinical Trial

— PREGA  

Official title:

Pregabalin vs. Placebo as an Add on for Complex Regional Pain Syndrome of the Upper Limb Managed by Stellate Ganglion Block

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00891397
• Other study ID #: 07-181
• Status: Terminated
• Phase: N/A
• First received: April 28, 2009
• Last updated: April 7, 2015
• Start date: November 2007
• Est. completion date: October 2010

Study information

• Verified date: April 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: October 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• Pregabalin
Dose of 150mg/day divided in two doses. Increased to 300mg/day then to 600mg/day, always divided in two doses for the day.

Other:
• Placebo
Sugar pill

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation, Pfizer

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly.		Three months	No
Secondary	Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form.		Three months	No