Conditions: Chronic Low Back Pain
Keywords: Flurbiprofen, low back pain, chronic low back pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 127
Healthy volunteers: no

Brief summary:
The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen tape for chronic low back pain (lasting greater than 3 months).

Detailed description:
This study is a multi-center, randomized, double-blind, placebo-controlled study in patients with daily low back pain below the 12th thoracic vertebra of greater than 3 months duration. Patients also had 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. The study began with a 14-day washout period of previously used pain medications. At the end of the 14-day baseline phase, patients were randomized to 1 of 4 treatments: Flurbiprofen tape applied once daily for 12 hours, Flurbiprofen tape applied once daily for 24 hours, placebo tape applied once daily for 12 hours, or placebo tape applied once daily for 24 hours. During the 7-day treatment phase, patients applied 2 treatment tapes once daily for 7 days. The tapes remained on for 12 or 24 hours of continuous treatment, depending on the treatment to which they were randomized. Patients were provided with rescue medication. After 7 days of tape treatment, patients returned to the clinic for a study exit visit.

Arms:
arm 1: Placebo tape remained on for 12 hours of continuous treatment per day. arm 2: Flurbiprofen tape remained on for 12 hours of continuous treatment per day. arm 3: Placebo tape remained on for 24 hours of continuous treatment per day. arm 4: Flurbiprofen tape remained on for 24 hours of continuous treatment per day.

Interventions: intervention 1: Placebo Tape (Arm 1) intervention 2: Flurbiprofen Tape (Arm 2) intervention 3: Placebo Tape (Arm 3) intervention 4: Flurbiprofen Tape (Arm 4)
Intervention descriptions: intervention 1: Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. intervention 2: Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. intervention 3: Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. intervention 4: Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.

Protocol document: