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)

NCT00891397

Last updated date
Study Location
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Complex Regional Pain Syndromes
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE Pregabalin vs. Placebo as an Add on for Complex Regional Pain Syndrome of the Upper Limb Managed by Stellate Ganglion Block
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Complex Regional Pain Syndromes
Intervention  ICMJE
  • 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 Name: Lyrica
  • Other: Placebo
    Sugar pill
Study Arms  ICMJE
  • Experimental: 1
    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.
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 2
    Ten patients will be be in the placebo group.
    Intervention: Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 4, 2011)
14
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2009)
30
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00891397
Other Study ID Numbers  ICMJE 07-181
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE
  • Pfizer
  • Hamilton Health Sciences Corporation
Investigators  ICMJE
Principal Investigator:Norman Buckley, MDHamilton Health Sciences Corporation
PRS Account McMaster University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP