GRASSP: Gralise® for Spine Surgery Pain

Phase 4

Completed

• Conditions: Post-laminectomy Pain Syndrome
• Interventions: Drug: Gralise®; Drug: Placebo

• Registration Number: NCT01764464
• Lead Sponsor: University of Rochester

Brief Summary

Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2016-03
• Study Completion: 2016-04
• Results First Submitted: 2018-10-12
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-09
• Last Update Submitted: 2019-07-09
• Results First Posted: 2019-07-30
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Gralise®	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®). 10 day washout (no intervention). 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).
Group B	Placebo	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). 10 day washout (no intervention). 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®).
Group B	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). 10 day washout (no intervention). 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®).
Group A	Placebo	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®). 10 day washout (no intervention). 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).

Primary Outcome Measures

Name	Time	Method
Mean Change in Numeric Rating Scale (NRS)	baseline to 6 weeks	Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable).

Secondary Outcome Measures

Name	Time	Method
Mean Change in Visual Analog Scale (VAS)	baseline to 6 weeks	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.
Mean Change in Modified Brief Pain Inventory- Short Form (mBPI-sf)	baseline to 6 weeks	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.
Insomnia Severity Index (ISI)	6 weeks	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.
Mean Change in Patient Global Assessment (PGA)	baseline to 6 weeks	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.
Mean McGill Pain Questionnaire-2 (MPQ-2)	6 weeks	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.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States