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


N/A
18 Years
65 Years
Not Enrolling
Both
Complex Regional Pain Syndromes

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Three months

Safety Issue:

No

Principal Investigator

Norman Buckley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hamilton Health Sciences Corporation

Authority:

Canada: Ethics Review Committee

Study ID:

07-181

NCT ID:

NCT00891397

Start Date:

November 2007

Completion Date:

October 2010

Related Keywords:

  • Complex Regional Pain Syndromes
  • CPRS
  • stellate ganglion block
  • pregabalin
  • pain
  • Type I
  • Synovial Cyst
  • Ganglion Cysts
  • Somatoform Disorders
  • Complex Regional Pain Syndromes

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