Prospective Analgesic Compound Efficacy (PACE) Study
Condition: Arthritis; Tendonitis; Gout; Radiculopathy; Muscle Spasms; Synovitis; Migraine; Headache
MeSH terms: Tendinopathy; Synovitis; Radiculopathy; Spasm; Headache
Study type: Observational [Patient Registry]

Summary: 
      A 24-week observational prospective study on the efficacy of topical non-steroidal
      anti-inflammatory drugs for the relief of pain.
    

Detailed description: 
      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
    

Intervention name(s): baclofen 2%; Bupivacaine hydrochloride 1%; Cyclobenzaprine hydrochloride 2%; Diclofenac Sodium 3%; Flurbiprofen 10%; Gabapentin 6%; Ketamine 10%; Lidocaine 2%; Prilocaine 2.5%; Meloxicam 0.09%; Sumatriptan 5%; Tizanidine 0.1%; Topiramate 2.5%; Capsaicin, USP 0.0375%; Menthol, NF 5.00 %
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream; compound topical cream
Other intervention name(s): baclofen; Bupivacaine hydrochloride; Cyclobenzaprine hydrochloride; Diclofenac Sodium; Flurbiprofen; Gabapentin; Ketamine; Lidocaine; Prilocaine; Meloxicam; Sumatriptan; Tizanidine; Topiramate; Capsaicin; Menthol
Intervention MeSH terms: Topiramate; Diclofenac; Meloxicam; Flurbiprofen; Lidocaine; Clonidine; Sumatriptan; Ketamine; Gabapentin; Amitriptyline; Tizanidine; Bupivacaine; Prilocaine; Cyclobenzaprine; Baclofen; Capsaicin; Menthol
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patient population will be taken from the patients normally treated at 1960 Family
        Practice. Patients not approached for the study will have known medical issues consistent
        with the exclusion criteria. Patients who can meet the medical requirements of the
        inclusion criteria for the study will be asked to participate. Patients who do not meet the
        inclusion criteria, meet any of the exclusion criteria, or decline to be involved in the
        study will be treated with traditional standard medical practices, and their standard of
        care will not change in any way.