Flurbiprofen Tape for Treatment of Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Placebo Tape (Arm 1); Flurbiprofen Tape (Arm 2); Placebo Tape (Arm 3); Flurbiprofen Tape (Arm 4)
Intervention description: Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.; 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.; Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.; 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 MeSH terms: Flurbiprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Flurbiprofen, low back pain, chronic low back pain

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).
    

Eligibility criteria:

        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.