Milnacipran for Chronic Pain in Knee Osteoarthritis (KOA)
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.
Degenerative Joint Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Milnacipran for the Pain, Sensory Sensitization and Mood Changes in Knee Osteoarthritis|
- McGill Pain Questionnaire - Short Form [ Time Frame: Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. ] [ Designated as safety issue: No ]The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).
- PamSys Actigraph Data [ Time Frame: 48 hours after visit 3 ] [ Designated as safety issue: No ]We used a body worn sensor (PAMSys™, Biosensics, LLC, MA)(25-27) embedded in a comfortable t-shirt at the sternal level. Participants wore the PAMSys after the visit for 48 hours. The device provides values related to subjects spontaneous physical activity including percentage of time standing and walking. These variables provide different indexes of participants' level of activity and activity organization, and were reported by subjects with KOA pain as relevant.
- Pain Anxiety Symptoms Scale (PASS) [ Time Frame: Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. ] [ Designated as safety issue: No ]Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.
- Pain Disability Index (PDI) [ Time Frame: Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. ] [ Designated as safety issue: No ]The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.
- Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10) [ Time Frame: Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. ] [ Designated as safety issue: No ]The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.
- Pain Visual Analogue Scale [ Time Frame: Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. ] [ Designated as safety issue: No ]Pain Visual Analogue Scale from 0-100 (0= no pain, and 100= most pain).
- Daily Diary Entries With Pain, Fatigue and Functioning Scores Three Times a Day [ Time Frame: electronic diary entries with pain, fatigue and functioning scores were completed three times a day during week 1 and week 11 ] [ Designated as safety issue: No ]Averages of daily diary outcomes were taken over the first and last week of the trial (week 1 and week 11) to compare pre and post treatment. diary was filled out 3 times a day and asked subjects to rate pain at rest, pain when walking, and fatigue on a scale 0-10 (0=none, and 10=the worst)
|Study Start Date:||November 2010|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Sugar Pill
Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
Other Name: "Sugar Pill"
Uptitration from 10mg to 50mg BID Milnacipran
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.
Other Name: Savella (milnacipran HCL) Tablets
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510457
|Principal Investigator:||Norman Harden, MD||Center for Pain Studies, Rehabilitation Institute of Chicago|