Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
53
14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®).
14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo).
University of Rochester
Rochester, New York, United States
Mean Change in Numeric Rating Scale (NRS)
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable).
Time frame: baseline to 6 weeks
Mean Change in Visual Analog Scale (VAS)
The VAS asks subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.
Time frame: baseline to 6 weeks
Mean Change in Patient Global Assessment (PGA)
Subjects will be asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA is measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.
Time frame: baseline to 6 weeks
Mean McGill Pain Questionnaire-2 (MPQ-2)
The McGill Pain questionnaire is 22 questions where patient rate their pain symptoms with each question scaled 0-10 for a total 220 points where a higher score indicates worse outcome.
Time frame: 6 weeks
Mean Change in Modified Brief Pain Inventory- Short Form (mBPI-sf)
The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). The scale ranges from 0 to 70. Higher scores indicate worse outcome.
Time frame: baseline to 6 weeks
Insomnia Severity Index (ISI)
The ISI has 7 questions with each question ranging from 0-4 for a total of 28 points with higher scores indicating more severe insomnia.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 weeks