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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) (PREGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00891397
Recruitment Status : Terminated (Unable to recruit patients)
First Posted : May 1, 2009
Last Update Posted : April 8, 2015
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndromes Drug: Pregabalin Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pregabalin vs. Placebo as an Add on for Complex Regional Pain Syndrome of the Upper Limb Managed by Stellate Ganglion Block
Study Start Date : November 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
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.
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

Placebo Comparator: 2
Ten patients will be be in the placebo group.
Other: Placebo
Sugar pill

Primary Outcome Measures :
  1. Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly. [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form. [ Time Frame: Three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00891397

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Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
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Principal Investigator: Norman Buckley, MD Hamilton Health Sciences Corporation
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Responsible Party: McMaster University Identifier: NCT00891397    
Other Study ID Numbers: 07-181
First Posted: May 1, 2009    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Keywords provided by McMaster University:
stellate ganglion block
Type I
Additional relevant MeSH terms:
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Ganglion Cysts
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Somatoform Disorders
Pathologic Processes
Mental Disorders
Connective Tissue Diseases
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs