Trial Outcomes & Findings for Flurbiprofen Tape for Treatment of Chronic Low Back Pain (NCT NCT00759330)

The study was conducted at 10 clinical sites in the US from September 2007 to July 2008. Patients with chronic LBP below the 12th thoracic vertebra of greater than 3 months duration and with an average daily pain score of 4 or greater on an 11-point categorical pain scale for the last 3 days of the baseline phase were eligible to participate.

Prior to randomization into the Tape Treatment Phase, participants began a 14-day washout period of previously used pain medications. Participants were then randomized to 1 of 4 treatments. After 7 days of treatment, patients returned to the clinic for a study exit visit. Participants were provided with rescue medication throughout the study.

Flurbiprofen Tape for Treatment of Chronic Low Back Pain

The primary efficacy endpoint was the cumulative summed pain intensity difference (SPID+) at Days 4 and 7 of the tape treatment phase as computed from the daily categorical pain scale score reported on the patient's daily diary during the tape treatment phase; pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable. Summed pain intensity difference is the sum of the pain intensity differences (PID). PID at each post-baseline evaluation was computed as the average baseline categorical pain scale score minus the post-baseline categorical pain scale score from the daily dairy. For patients with multiple pain scores reported on a given post-baseline study day, the PID scores were averaged to compute one daily PID score for each patient.

+PID = pre-treatment value at baseline - post-treatment value at day of evaluation, where: pre-treatment value at baseline = average daily pain over the last 3 days of the baseline phase (ie, average of daily averages of the categorical pain scale scores for the last 3 days of the baseline phase). Pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable. A positive PID indicates a reduction in pain.

Patients rated their lower back pain, caused by normal activity and movement, on an 11-point categorical pain scale, where: 0 = no pain, and 10 = worst pain imaginable. Patients rated their lower back pain every 12 hours, at any time they took medication including rescue medication for any type of pain, and if they applied or removed their treatment tapes at a time other than the scheduled time. Data are reported as the daily average categorical pain scale score by treatment group.

Patients completed the FRI, a 10-item back pain-specific measure of function questionnaire describing the condition at the time the questionnaire was completed; each item (pain intensity, sleeping, personal care, travel, etc.) was rated on a 5-point scale, where 0 = best outcome, 4 = worst outcome. FRI was reported as the percent change from baseline at Day 7 of the tape treatment phase, where: Total FRI score = sum of the 10 questions. The total FRI score ranged from 0 (best outcome) to 40 (worst outcome). Percent change = (\[baseline - Day 7\]/baseline)\*100. A positive percent change indicates a favorable treatment effect.

At baseline and Day 7 of the tape treatment phase, patients had an assessment of tenderness bilaterally at the sacroiliac joint, greater trochanter of the hip, gluteus medius and minimus, and paraspinal muscles at L3-L4, L4-L5, and L5-S1. The investigator or research nurse pressed 12 specific areas of the body (6 locations, left and right sides), and patients were asked to rate the intensity of their pain at those 12 areas using an 11-point scale, where: 0 = no pain, 10 = the worst pain the patient has ever experienced. The total tender point examination score ranged from 0 (best outcome) to 120 (worst outcome). Change from baseline = baseline - Day 7. A positive change indicates a favorable treatment effect.

At Day 7, patients provided their PGIC with regard to lower back pain response to treatment, using a 7-point scale, where: 1 = very much improved, 7 = very much worse.

The percentage of patients who used rescue medication during the tape treatment phase.

The total amount (mg) of rescue medication used during the tape treatment phase.

The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy.

At Day 7, patients assessed the wearability of their treatment tape (ease of application, stays in place, comfortable to wear) using a 4-point scale, where: 1 = Excellent, 4 = Poor.