Migraine Clinical Trial
Official title:
Prospective Analgesic Compound Efficacy (PACE) Study
A 24-week observational prospective study on the efficacy of topical non-steroidal anti-inflammatory drugs for the relief of pain.
Objectives
The primary objective is the change in pain levels as measured by a 10-point visual analog
scale (VAS). Secondary objectives are changes in concomitant pain medication use, quality of
life, and patient satisfaction with pain management.
Design and Outcomes
The study will be conducted at 1 family practice medical clinic in Houston, TX. Patients will
be prescribed a pain cream compound based on their symptoms and medical history. Periodic
surveys will be administered and concomitant medications recorded to ascertain current pain
levels, quality of life, and satisfaction with current pain levels. Blood tests will be
performed to monitor liver and kidney function.
Interventions and Duration
Non-steroidal anti-inflammatory steroid (NSAID) topical cream will be prescribed to patients
presenting with pain. For patients with localized pain, they will also be prescribed a
transdermal analgesic patch to wear at the site of pain. Subjects will be followed for
24-weeks with surveys administered at baseline, and 1, 2, 4, 8, 12, 16, 20, and 24-weeks
after baseline with blood tests performed at 12 and 24-weeks. If patients do not find
satisfactory pain relief or experience undesirable side effects from the cream they will be
given a prescription for an oral NSAID at anytime during the 24-week observation.
Sample Size and Population
500 patients will be enrolled in the study between March 1, 2015 and March 1, 2017. Subjects
will be screened from the patient population at 1960 Family Practice, 837 Cupress Creek
Parkway, Suite 105, Houston Texas. Subjects will have presented with a primary complaint of
pain. Subjects will be stratified by the following medical indications; Arthritis Muscle
Spasms Tendonitis Idiopathic Gout Synovitis Radiculopathy Migraine
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