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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)

Primary Purpose

Complex Regional Pain Syndromes

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Pregabalin

Placebo

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes focused on measuring CPRS, stellate ganglion block, pregabalin, pain, Type I

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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.

Ten patients will be be in the placebo group.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00891397

First Posted

April 28, 2009

Last Updated

April 7, 2015

Sponsor

McMaster University

Collaborators

Pfizer, Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00891397

Brief Title

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)

Acronym

PREGA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

Unable to recruit patients

Study Start Date

November 2007 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

Pfizer, Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complex Regional Pain Syndromes

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Placebo Comparator

Arm Description

Ten patients will be be in the placebo group.

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Other Intervention Name(s)

Lyrica

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Sugar pill

Primary Outcome Measure Information:

Title

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

Time Frame

Three months

Secondary Outcome Measure Information:

Title

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

Time Frame

Three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Norman Buckley, MD

Organizational Affiliation

Hamilton Health Sciences Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

15911152

Citation

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.

Results Reference

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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)

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