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)

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

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00891397

Acronym

PREGA

Enrollment

Registered

2009-05-01

Start date

2007-11-01

Completion date

2010-10-01

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndromes

Keywords

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

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.

Interventions

DRUGPregabalin

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

OTHERPlacebo

Sugar pill

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Pain relief assessed by an observer blinded to group allocation with daily pain scores and assessed weekly.	Three months

Secondary

Measure	Time frame
Functional disability assessed by an observer blinded to group allocation. Patient rated wrist and hand evaluation form.	Three months

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORNorman Buckley, MD

Hamilton Health Sciences Corporation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026