Chronic Low Back Pain
Conditions
Keywords
Flurbiprofen, low back pain, chronic low back pain
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.
Interventions
Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.
DRUGFlurbiprofen Tape (Arm 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.
DRUGPlacebo Tape (Arm 3)
Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.
DRUGFlurbiprofen Tape (Arm 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.
Sponsors
Teikoku Pharma USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* male or female 18 to 80 years; * signed an informed consent; * daily LBP below the 12th thoracic vertebra of greater than 3 months' duration; * able to ambulate at least 100 meters; * in stable general health with laboratory values within normal limits * no evidence of drug abuse or residual opiates; determined by urine drug screening; * diagnosis of chronic LBP verified by medical records; * female patients must be postmenopausal (defined as 1 year without menses), physically incapable of becoming pregnant, or using an acceptable birth control method. Non-postmenopausal patients must have confirmation of a negative urine pregnancy test; * must read and speak English; * must be reliable and mentally competent to complete study measurements; * must be available for the study visits and telephone checks from study entry to study completion. * male patients must use an acceptable method of birth control with their female partners; * rates their pain at 3 or higher on an 11-point Categorical Pain Scale for LBP over the prior week (7 days) of Visit 1. * over the last 3 days of the Baseline Phase, had a computed average pain score of 4 or greater on an 11-point Categorical Pain Scale * discontinued the use of any topical pain medications, salves, anticonvulsants, oral NSAIDs, muscle relaxants, opioids, or anti-inflammatory steroids during the Baseline Phase. Acetaminophen, at a dose of ≤ 1000 mg per day is acceptable; * able to discontinue the use of therapy defined as ice, heat, chiropractic care, physical therapy, acupuncture and acupressure on their lower back area during the Baseline Phase.
Exclusion criteria
* open skin lesion within the painful area; * experiencing LBP for less than 3 months; * undergone back surgery within the past 3 months or has plans for back surgery within 30 days post-study; * participated in clinical treatment studies within 30 days of study entry; * chronic back pain which is due to fibromyalgia or connective tissue disorder (lupus, rheumatoid arthritis, ankylosing spondylitis, Reiter's syndrome, etc.); * LBP due to malignancy, vertebral fracture, or infection; * used opioids (including low potency/low dose opioid combinations and tramadol) more than 2 times per week within 30 days of study entry. Opioids and tramadol must not have been taken at least 4 days prior to study entry; * had injection therapy within 30 days of study entry, including corticosteroids; * a clinically significant psychiatric disorder (severe depression, other Axis I or Axis II disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV); * taking lithium, furosemide, and/or thiazides; * considered unreliable as to medication compliance (if any medication other than 1000 mg or less of acetaminophen a day was taken for any type of pain, the patient was discontinued) or adherence to scheduled appointments as determined by the investigators; * a prior history of GI bleeds/ulcers or clinically significant liver/kidney disease; * known hypersensitivity to flurbiprofen or other NSAIDs; * has a coagulation disorder or is taking warfarin or other anticoagulants (aspirin at a dose of \[≤ 81 mg\] is acceptable); * clinically significant fluid retention, cardiovascular disease (CVD), hypertension, or heart failure; * had coronary artery bypass graft surgery (CABG), cardiovascular thrombotic event, myocardial infarction (MI) and/or stroke within 1 year of Visit 1; * had unresolved litigation related to back injury or other pain complaints; settled disability claims/payments (Worker's Compensation, state/federal/private disability plans) were allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Summed Pain Intensity Difference (SPID+) | Days 4 and 7 of tape treatment phase | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acetaminophen Used During the Tape Treatment Phase | Day 1 through Day 7 of the tape treatment phase | The percentage of patients who used rescue medication during the tape treatment phase. |
| Pain Intensity Difference (PID+) | Days 1 through 7 of tape treatment phase | +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. |
| Average Daily Categorical Pain Scale Scores | Days 1 through 7 of tape treatment phase | 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. |
| Patient Global Impression of Change (PGIC) | Day 7 | 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. |
| Change From Baseline in Total Tender Point Examination Score | Baseline to Day 7 of tape treatment phase | 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. |
| Percentage of Patients Who Discontinued | Days 1 through Day 7 of tape treatment phase | The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy. |
| Patient Assessment of Wearability of Therapy | Day 7 | 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. |
| Percent Change From Baseline in Total Functional Rating Index (FRI) | baseline to Day 7 of tape treatment phase | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Tape, Daily for 12 Hours Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. | 20 |
| Flurbiprofen Tape, Daily for 12 Hours Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 12 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. | 42 |
| Placebo Tape, Daily for 24 Hours Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. | 22 |
| Flurbiprofen Tape, Daily for 24 Hours Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. The tapes remained on for 24 hours of continuous treatment per day. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. | 43 |
| Total | 127 |
Baseline characteristics
| Characteristic | Placebo Tape, Daily for 12 Hours | Flurbiprofen Tape, Daily for 12 Hours | Placebo Tape, Daily for 24 Hours | Flurbiprofen Tape, Daily for 24 Hours | Total |
|---|---|---|---|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 14.47 | 50.1 years STANDARD_DEVIATION 13.02 | 53.6 years STANDARD_DEVIATION 13.46 | 53.0 years STANDARD_DEVIATION 11.98 | 52.1 years STANDARD_DEVIATION 13.2 |
| Sex: Female, Male Female | 9 Participants | 23 Participants | 9 Participants | 28 Participants | 69 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 13 Participants | 15 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 20 | 11 / 42 | 12 / 22 | 11 / 43 |
| serious Total, serious adverse events | 0 / 20 | 0 / 42 | 0 / 22 | 0 / 43 |
Outcome results
Primary
Cumulative Summed Pain Intensity Difference (SPID+)
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.
Time frame: Days 4 and 7 of tape treatment phase
Population: Reported data are based on Intent-to-Treat patient population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Tape, Daily for 12 Hours | Cumulative Summed Pain Intensity Difference (SPID+) | SPID for Day 4 | 4.6 units on a scale | Standard Error 1.62 |
| Placebo Tape, Daily for 12 Hours | Cumulative Summed Pain Intensity Difference (SPID+) | SPID for Day 7 | 8.4 units on a scale | Standard Error 2.95 |
| Flurbiprofen Tape, Daily for 12 Hours | Cumulative Summed Pain Intensity Difference (SPID+) | SPID for Day 7 | 12.1 units on a scale | Standard Error 2.06 |
| Flurbiprofen Tape, Daily for 12 Hours | Cumulative Summed Pain Intensity Difference (SPID+) | SPID for Day 4 | 6.3 units on a scale | Standard Error 1.14 |
| Placebo Tape, Daily for 24 Hours | Cumulative Summed Pain Intensity Difference (SPID+) | SPID for Day 4 | 6.7 units on a scale | Standard Error 1.56 |
| Placebo Tape, Daily for 24 Hours | Cumulative Summed Pain Intensity Difference (SPID+) | SPID for Day 7 | 13.0 units on a scale | Standard Error 2.82 |
| Flurbiprofen Tape, Daily for 24 Hours | Cumulative Summed Pain Intensity Difference (SPID+) | SPID for Day 4 | 5.2 units on a scale | Standard Error 1.13 |
| Flurbiprofen Tape, Daily for 24 Hours | Cumulative Summed Pain Intensity Difference (SPID+) | SPID for Day 7 | 10.2 units on a scale | Standard Error 2.05 |
Secondary
Acetaminophen Used During the Tape Treatment Phase
The percentage of patients who used rescue medication during the tape treatment phase.
Time frame: Day 1 through Day 7 of the tape treatment phase
Population: Reported data are based on Intent-to-Treat patient population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Tape, Daily for 12 Hours | Acetaminophen Used During the Tape Treatment Phase | 50 percentage of patients |
| Flurbiprofen Tape, Daily for 12 Hours | Acetaminophen Used During the Tape Treatment Phase | 54.8 percentage of patients |
| Placebo Tape, Daily for 24 Hours | Acetaminophen Used During the Tape Treatment Phase | 36.4 percentage of patients |
| Flurbiprofen Tape, Daily for 24 Hours | Acetaminophen Used During the Tape Treatment Phase | 62.8 percentage of patients |
Secondary
Acetaminophen Used During the Tape Treatment Phase
The total amount (mg) of rescue medication used during the tape treatment phase.
Time frame: Day 1 through Day 7 of the tape treatment phase
Population: Reported data are based on Intent-to-Treat patient population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Tape, Daily for 12 Hours | Acetaminophen Used During the Tape Treatment Phase | 2226.9 mg | Standard Error 537.6 |
| Flurbiprofen Tape, Daily for 12 Hours | Acetaminophen Used During the Tape Treatment Phase | 1617.5 mg | Standard Error 376 |
| Placebo Tape, Daily for 24 Hours | Acetaminophen Used During the Tape Treatment Phase | 1585.4 mg | Standard Error 515.2 |
| Flurbiprofen Tape, Daily for 24 Hours | Acetaminophen Used During the Tape Treatment Phase | 2141.3 mg | Standard Error 373.5 |
Secondary
Average Daily Categorical Pain Scale Scores
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.
Time frame: Days 1 through 7 of tape treatment phase
Population: Reported data are based on Intent-to-Treat patient population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 1 | 5.3 units on a scale | Standard Deviation 2.1 |
| Placebo Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 4 | 5.0 units on a scale | Standard Deviation 2.57 |
| Placebo Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 3 | 5.0 units on a scale | Standard Deviation 2.65 |
| Placebo Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 7 | 4.6 units on a scale | Standard Deviation 2.55 |
| Placebo Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 6 | 4.9 units on a scale | Standard Deviation 2.78 |
| Placebo Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 5 | 5.1 units on a scale | Standard Deviation 2.74 |
| Placebo Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 2 | 4.7 units on a scale | Standard Deviation 2.37 |
| Flurbiprofen Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 7 | 3.8 units on a scale | Standard Deviation 2.33 |
| Flurbiprofen Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 1 | 4.8 units on a scale | Standard Deviation 1.92 |
| Flurbiprofen Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 2 | 4.7 units on a scale | Standard Deviation 1.96 |
| Flurbiprofen Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 3 | 4.5 units on a scale | Standard Deviation 2.04 |
| Flurbiprofen Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 4 | 4.0 units on a scale | Standard Deviation 2.2 |
| Flurbiprofen Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 5 | 4.4 units on a scale | Standard Deviation 2.56 |
| Flurbiprofen Tape, Daily for 12 Hours | Average Daily Categorical Pain Scale Scores | Day 6 | 4.2 units on a scale | Standard Deviation 2.46 |
| Placebo Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 4 | 4.5 units on a scale | Standard Deviation 2.59 |
| Placebo Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 1 | 5.3 units on a scale | Standard Deviation 2.18 |
| Placebo Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 7 | 4.1 units on a scale | Standard Deviation 2.5 |
| Placebo Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 5 | 4.2 units on a scale | Standard Deviation 2.38 |
| Placebo Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 6 | 4.2 units on a scale | Standard Deviation 2.43 |
| Placebo Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 3 | 4.3 units on a scale | Standard Deviation 2.36 |
| Placebo Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 2 | 4.5 units on a scale | Standard Deviation 2.26 |
| Flurbiprofen Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 3 | 4.8 units on a scale | Standard Deviation 2.39 |
| Flurbiprofen Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 6 | 4.8 units on a scale | Standard Deviation 2.6 |
| Flurbiprofen Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 4 | 5.0 units on a scale | Standard Deviation 2.54 |
| Flurbiprofen Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 1 | 5.7 units on a scale | Standard Deviation 1.85 |
| Flurbiprofen Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 5 | 4.8 units on a scale | Standard Deviation 2.44 |
| Flurbiprofen Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 7 | 4.4 units on a scale | Standard Deviation 2.59 |
| Flurbiprofen Tape, Daily for 24 Hours | Average Daily Categorical Pain Scale Scores | Day 2 | 4.9 units on a scale | Standard Deviation 2.51 |
Secondary
Change From Baseline in Total Tender Point Examination Score
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.
Time frame: Baseline to Day 7 of tape treatment phase
Population: Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Tape, Daily for 12 Hours | Change From Baseline in Total Tender Point Examination Score | 13.9 units on a scale | Standard Error 4.4 |
| Flurbiprofen Tape, Daily for 12 Hours | Change From Baseline in Total Tender Point Examination Score | 11.7 units on a scale | Standard Error 3.03 |
| Placebo Tape, Daily for 24 Hours | Change From Baseline in Total Tender Point Examination Score | 19.2 units on a scale | Standard Error 4.12 |
| Flurbiprofen Tape, Daily for 24 Hours | Change From Baseline in Total Tender Point Examination Score | 9.2 units on a scale | Standard Error 3.03 |
Secondary
Pain Intensity Difference (PID+)
+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.
Time frame: Days 1 through 7 of tape treatment phase
Population: Reported data are based on Intent-to-Treat patient population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 1 | 0.9 units on a scale | Standard Error 0.38 |
| Placebo Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 6 | 1.2 units on a scale | Standard Error 0.5 |
| Placebo Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 5 | 1.1 units on a scale | Standard Error 0.49 |
| Placebo Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 2 | 1.4 units on a scale | Standard Error 0.46 |
| Placebo Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 7 | 1.6 units on a scale | Standard Error 0.52 |
| Placebo Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 3 | 1.2 units on a scale | Standard Error 0.48 |
| Placebo Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 4 | 1.1 units on a scale | Standard Error 0.49 |
| Flurbiprofen Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 6 | 1.9 units on a scale | Standard Error 0.35 |
| Flurbiprofen Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 4 | 2.1 units on a scale | Standard Error 0.34 |
| Flurbiprofen Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 3 | 1.6 units on a scale | Standard Error 0.34 |
| Flurbiprofen Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 5 | 1.7 units on a scale | Standard Error 0.34 |
| Flurbiprofen Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 7 | 2.2 units on a scale | Standard Error 0.36 |
| Flurbiprofen Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 2 | 1.3 units on a scale | Standard Error 0.32 |
| Flurbiprofen Tape, Daily for 12 Hours | Pain Intensity Difference (PID+) | Day 1 | 1.3 units on a scale | Standard Error 0.26 |
| Placebo Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 4 | 1.8 units on a scale | Standard Error 0.47 |
| Placebo Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 1 | 1.1 units on a scale | Standard Error 0.36 |
| Placebo Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 2 | 1.8 units on a scale | Standard Error 0.44 |
| Placebo Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 3 | 2.0 units on a scale | Standard Error 0.46 |
| Placebo Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 5 | 2.1 units on a scale | Standard Error 0.47 |
| Placebo Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 6 | 2.0 units on a scale | Standard Error 0.48 |
| Placebo Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 7 | 2.2 units on a scale | Standard Error 0.49 |
| Flurbiprofen Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 3 | 1.6 units on a scale | Standard Error 0.33 |
| Flurbiprofen Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 7 | 1.9 units on a scale | Standard Error 0.36 |
| Flurbiprofen Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 6 | 1.5 units on a scale | Standard Error 0.35 |
| Flurbiprofen Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 2 | 1.4 units on a scale | Standard Error 0.32 |
| Flurbiprofen Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 1 | 0.8 units on a scale | Standard Error 0.26 |
| Flurbiprofen Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 5 | 1.5 units on a scale | Standard Error 0.34 |
| Flurbiprofen Tape, Daily for 24 Hours | Pain Intensity Difference (PID+) | Day 4 | 1.4 units on a scale | Standard Error 0.34 |
Secondary
Patient Assessment of Wearability of Therapy
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.
Time frame: Day 7
Population: Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 3: Fair | 5 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 4: Poor | 8 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 3: Fair | 0 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 2: Good | 3 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 1: Excellent | 8 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 2: Good | 5 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 1: Excellent | 1 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 2: Good | 8 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 1: Excellent | 8 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 3: Fair | 5 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 4: Poor | 3 participants |
| Placebo Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 4: Poor | 3 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 1: Excellent | 18 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 1: Excellent | 1 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 2: Good | 9 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 3: Fair | 11 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 4: Poor | 20 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 1: Excellent | 16 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 2: Good | 11 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 3: Fair | 11 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 4: Poor | 3 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 2: Good | 14 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 3: Fair | 9 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 4: Poor | 0 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 2: Good | 5 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 3: Fair | 7 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 3: Fair | 9 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 1: Excellent | 0 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 4: Poor | 4 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 1: Excellent | 9 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 2: Good | 3 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 2: Good | 8 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 4: Poor | 3 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 1: Excellent | 6 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 4: Poor | 10 participants |
| Placebo Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 3: Fair | 2 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 1: Excellent | 10 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 3: Fair | 12 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 3: Fair | 2 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 4: Poor | 4 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 3: Fair | 2 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 2: Good | 20 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 2: Good | 14 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 1: Excellent | 3 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Stays in place, 4: Poor | 10 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 2: Good | 9 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Ease of application, 4: Poor | 18 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Assessment of Wearability of Therapy | Comfortable to wear, 1: Excellent | 22 participants |
Secondary
Patient Global Impression of Change (PGIC)
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.
Time frame: Day 7
Population: Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 1: Very much improved | 3 participants |
| Placebo Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 6: Much worse | 0 participants |
| Placebo Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 5: Worse | 1 participants |
| Placebo Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 2: Much improved | 1 participants |
| Placebo Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 7: Very much worse | 0 participants |
| Placebo Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 3: Improved | 4 participants |
| Placebo Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 4: No change | 10 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 6: Much worse | 0 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 4: No change | 10 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 3: Improved | 12 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 5: Worse | 2 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 7: Very much worse | 0 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 2: Much improved | 10 participants |
| Flurbiprofen Tape, Daily for 12 Hours | Patient Global Impression of Change (PGIC) | 1: Very much improved | 7 participants |
| Placebo Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 4: No change | 8 participants |
| Placebo Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 1: Very much improved | 3 participants |
| Placebo Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 2: Much improved | 3 participants |
| Placebo Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 3: Improved | 8 participants |
| Placebo Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 5: Worse | 0 participants |
| Placebo Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 6: Much worse | 0 participants |
| Placebo Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 7: Very much worse | 0 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 3: Improved | 11 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 7: Very much worse | 0 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 6: Much worse | 0 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 2: Much improved | 4 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 1: Very much improved | 9 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 5: Worse | 0 participants |
| Flurbiprofen Tape, Daily for 24 Hours | Patient Global Impression of Change (PGIC) | 4: No change | 18 participants |
Secondary
Percentage of Patients Who Discontinued
The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy.
Time frame: Days 1 through Day 7 of tape treatment phase
Population: Reported data are based on Intent-to-Treat patient population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Tape, Daily for 12 Hours | Percentage of Patients Who Discontinued | 0 percentage of patients who discontinued |
| Flurbiprofen Tape, Daily for 12 Hours | Percentage of Patients Who Discontinued | 2.4 percentage of patients who discontinued |
| Placebo Tape, Daily for 24 Hours | Percentage of Patients Who Discontinued | 0 percentage of patients who discontinued |
| Flurbiprofen Tape, Daily for 24 Hours | Percentage of Patients Who Discontinued | 2.3 percentage of patients who discontinued |
Secondary
Percent Change From Baseline in Total Functional Rating Index (FRI)
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.
Time frame: baseline to Day 7 of tape treatment phase
Population: Reported data are based on Intent-to-Treat patient population. Discrepancy in the number of participants analyzed for this outcome measure is due to discontinuations: 1 participant in the placebo tape12 hour group and 2 participants in the flurbiprofen tape groups (1 in the 12 hour group and 1 in the 24 hour group).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Tape, Daily for 12 Hours | Percent Change From Baseline in Total Functional Rating Index (FRI) | 20.6 percent change from baseline | Standard Error 7.4 |
| Flurbiprofen Tape, Daily for 12 Hours | Percent Change From Baseline in Total Functional Rating Index (FRI) | 29.0 percent change from baseline | Standard Error 5.1 |
| Placebo Tape, Daily for 24 Hours | Percent Change From Baseline in Total Functional Rating Index (FRI) | 28.2 percent change from baseline | Standard Error 6.93 |
| Flurbiprofen Tape, Daily for 24 Hours | Percent Change From Baseline in Total Functional Rating Index (FRI) | 25.4 percent change from baseline | Standard Error 5.1 |