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)

McMaster University

Status: Terminated

Conditions: Complex Regional Pain Syndromes

Treatments: Drug: Pregabalin; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00891397

07-181

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups, including a placebo group

1

Experimental group

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.

Treatment:

Drug: Pregabalin

2

Placebo Comparator group

Description:

Ten patients will be be in the placebo group.

Treatment:

Other: Placebo