Chronic Pain Clinical Trial
— KOAOfficial title:
Milnacipran for the Pain, Sensory Sensitization and Mood Changes in Knee Osteoarthritis
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Knee pain and osteophytes on radiographs OR - Knee pain plus patient age of 40 years or older, morning stiffness lasting 30 minutes or less, and crepitus (cracking sound) during motion - Experiences chronic pain for 6 months or longer - Average pain rating of worse knee is equal to 4 or greater on a 0-10 scale - If female, is not pregnant or breast feeding, and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl) - Able to walk at least ½ a city block a day, and agrees to try and slowly increase that over the course of study - Able to read and speak English and provide informed consent - Able to understand and comply with all data collection methodology including electronic diary - Subject agrees to 1) continue their stable drug regimen with no changes during the course of study, 2) only use Tylenol 325 mg of tablets (a maximum of 8 tablets a day) for breakthrough pain, and 3) not use Tylenol or any other pain medicines 12 hours before testing. Exclusion Criteria: - Subject takes SNRIs (Savella, Cymbalta, Venlafaxine) or other neuroamine re-uptake blockers for mood disorders - Subject is allergic to SSRIs, SNRIs, or milnacipran - Subject has severe or untreated psychiatric disturbance (e.g. mania, depression, anxiety, substance dependence) - Subject is medicated with 'triptans, MAOIs, SSRIs, other SNRIs, tricyclic or heterocyclic antidepressants, lithium, epinephrine, norepinephrine, clonidine or digoxin during the trial - Subject has a clinical diagnosis of fibromyalgia - Subject has severe ongoing or unaddressed medical conditions (e.g. Renal or Hepatic disease [creatinine>1.5 ml/dl; AST or ALT> 3x normal limit], uncontrolled hypertension, severe cardiac rate or rhythm disorders, rheumatologic disease (e.g. polymyalgia rheumatica), narrow angle glaucoma, hyponatremia, clotting disorders, uncontrolled seizure disorder or urinary retention) - Subject has cardiac implants - Subject has a knee replacement - Subject plans to start new pain treatments or therapies during the study (e.g. new pain medication, injections, PT, surgery) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr. Norman Harden | Forest Laboratories |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | McGill Pain Questionnaire - Short Form | 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). | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. | No |
Primary | PamSys Actigraph Data | 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. | 48 hours after visit 3 | No |
Primary | Pain Anxiety Symptoms Scale (PASS) | 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. | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. | No |
Primary | Pain Disability Index (PDI) | 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. | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. | No |
Primary | Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10) | 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. | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. | No |
Primary | Pain Visual Analogue Scale | Pain Visual Analogue Scale from 0-100 (0= no pain, and 100= most pain). | Collected at 2 visits over 11 weeks: Visit 1 and Visit 3. | No |
Secondary | Daily Diary Entries With Pain, Fatigue and Functioning Scores Three Times a Day | 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) | electronic diary entries with pain, fatigue and functioning scores were completed three times a day during week 1 and week 11 | No |
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