Milnacipran for Chronic Pain in Knee Osteoarthritis
Condition: Knee Osteoarthritis; Degenerative Joint Disease; Chronic Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases; Chronic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The patients are asked to take part in this study because you have chronic pain as a result
      of knee osteoarthritis. This study is done to investigate the pain relieving effects of the
      study drug Savella (milnacipran HCl) for people who experience chronic osteoarthritis pain.
      The purpose of this research is to look at how the study drug can be used to benefit people
      who experience osteoarthritis knee pain. This is a phase IV study done to study the safety
      and effectiveness of the drug. At this point the drug is already approved by the Food and
      Drug Administration for people with fibromyalgia but it has not yet been approved for people
      with knee osteoarthritis.
    

Detailed description: 
      If you are in this study, you will be placed in one of two study groups: one group will
      receive the study drug and one will receive a placebo. You will be assigned a study group by
      chance using a process similar to the flip of a coin.

      At the first visit (week one) we will review and sign the informed consent, obtain your
      medical health history, and conduct a brief physical exam. You will also complete several
      questionnaires about your pain. You will be assessed for your eligibility to participate in
      this study. If you are eligible, we will conduct some physical and sensory tests and collect
      a blood sample. The physical tests include a stair climb, 6-minute treadmill test and a
      1-minute sit to stand test. The sensory tests allow us to understand your perception of
      various stimuli such as vibration, light touch, pinprick, heat, cold, hot pain, and cold
      pain. At the end of the first visit you will be given an electronic diary to record your pain
      throughout the study. We will also ask you to wear a device in a T-shirt, similar to an
      accelerometer, that will be used to record your sleep quality and physical activity for 2
      days.

      At the second (week two) and third visits (week nine) you will be asked to complete the same
      questionnaires, physical and sensory tests as during the first visit. You will also have to
      wear the t-shirt with the device for 2 days after each visit.
    

Intervention name(s): Milnacipran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.; Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
Other intervention name(s): Savella (milnacipran HCL) Tablets; "Sugar Pill"
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis; Degenerative Joint Disease; Chronic Pain; Knee Pain