Open-label Milnacipran for Persistent Knee Pain One Year After Total Knee Arthroplasty (TKA)
|Knee Pain After Total Knee Arthroplasty Osteoarthritis Pain||Drug: Open-label flexibly dosed milnacipran||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-label Milnacipran for Persistent Knee Pain One Year After Total Knee Arthroplasty (TKA)|
- Change in Pain Visual Analogue Scale(VAS). [ Time Frame: baseline and endpoint 12 weeks ]
The primary outcome is change in pain VAS from baseline to 12 weeks (baseline score minus 12 week or endpoint score; positive number reflects reduction in pain score). The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm:
0= absence of pain or no pain noted 100 = worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity.
- Change in Knee Society Score (KSS). [ Time Frame: between baseline and endpoint (12 weeks or early termination) ]
KSS measures subjective pain and objective function by joint physical exam. This secondary outcome was the change in Knee Society Score(KSS)from baseline through 12 weeks.
KSS scores measured on a scale of 0 to 100 mm:
0 = absence of pain or no pain noted 100= worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity.
- Global Rating of Change [ Time Frame: Endpoint (12 weeks or early termination) ]
- Change in Total Score of Multidimensional Fatigue Inventory (MFI-20) [ Time Frame: Baseline to endpoint (12 weeks or early termination) ]
Measures subjective fatigue.20-item self-report instrument consisting of five scales: General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, and Mental Fatigue.
Each scale contains four items rated on a scale of one to 5 with the scale score of one having the anchor of entirely true and the scale score of 5 having the anchor of no, not true. The five scales were identified through factor analysis and are assumed to measure different aspects of fatigue. Lowest possible total score = 20 (absent fatigue) Highest possible total score = 100 (maximum fatigue) Total mean cumulative scores were reported
- Change in the Beck Depression Inventory (BDI-II) [ Time Frame: Baseline to endpoint (12 weeks or early termination) ]
The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The higher the score the degree of depression.
- Change in the Montgomery Asberg Depression Rating Scale [ Time Frame: Between baseline and endpoint (12 weeks or early termination) ]
Staff-rated assessment of depressive symptoms. Scale is as follows:
0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression
- Change in Total Score of State Trait Anxiety Inventory (STAI) [ Time Frame: baseline and endpoint (12 weeks or early termination) ]
Assessment of subjective symptoms of current anxiety and chronic anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Lowest total score is 40 (absent anxiety) Highest total score is 160 (maximum anxiety) Total mean cumulative scores were reported.
- Change in Total Score of Short Form-36 (SF-36), Measuring Perceived Quality of Life [ Time Frame: baseline and endpoint (12 weeks or early termination) ]
Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The eight sections are:
- physical functioning,
- bodily pain,
- general health perceptions,
- physical role functioning,
- emotional role functioning,
- social role functioning,
- mental health
0= lowest quality of life 100= high quality of life Higher scores reflect higher quality of life. Total mean cumulative scores were reported.
|Study Start Date:||October 2010|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Open-label flexibly dosed milnacipran
Drug: Open-label flexibly dosed milnacipran
Other Name: Savella
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780389
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Davi M Marks, MD||Duke University|