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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Complex Regional Pain Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Pregabalin

Intervention Type 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.

2

Ten patients will be be in the placebo group.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Sugar pill

Interventions

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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.

Intervention Type DRUG

Placebo

Sugar pill

Intervention Type OTHER

Other Intervention Names

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Lyrica

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No