Prospective Analgesic Compound Efficacy (PACE) Study
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
Inclusion Criteria:

 -  4.1.1 Primary complaint or clinical findings of arthritis, tendonitis, gout,
 synovitis, radiculopathy, muscle spasms, migraines, and/or idiopathic pain.

 4.1.2 No new pain medications of any kind in the last 4 weeks. 4.1.3 Between the ages of
 18-85yrs.

 Exclusion Criteria:

 -  4.2.1 Current or history of disease or disorders of the liver, kidneys,
 gastrointestinal system, or cardiovascular system.

 4.2.2 Blood test indicating kidney, liver, or cardiovascular function outside of normal
 clinically accepted ranges. Blood test must be performed in the last 7 days.

 4.2.3 Broken or inflamed skin, burns, open wounds, atopic dermatitis or eczema in the area
 of pain where the compound cream and transdermal patch would be applied.

 4.2.4 Women who are pregnant, nursing, or planning to become pregnant in the next 52-weeks.

 4.2.5 Allergy/sensitivity to study drugs or their formulations. 4.2.6 Active drug or
 alcohol use or dependence that, in the opinion of the site investigator, would interfere
 with adherence to study requirements.

 4.2.7 Serious illness (requiring systemic treatment and/or hospitalization) until subject
 either completes therapy or is clinically stable on therapy, in the opinion of the site
 investigator, for at least 14 days prior to study entry.

 4.2.8 Inability or unwillingness of subject to give written informed consent.