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 | Terminated

• 1 other identifier: 07-181
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndromes

Keywords

CPRS; stellate ganglion block; pregabalin; pain; Type I

Outcome Measures

Primary Outcomes (1)

• Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly.

  Three months

Secondary Outcomes (1)

• Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form.

  Three months

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

Ten patients will be be in the placebo group.

Other: Placebo

Interventions

Pregabalin DRUG

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

Also known as: Lyrica

1

Placebo OTHER

Sugar pill

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Pfizer: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related 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):254-263. doi: 10.1016/j.pain.2005.02.032. Epub 2005 Apr 18.

  PMID: 15911152 BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Norman Buckley, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: May 1, 2009
• Study Start: November 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

CA (1)