Milnacipran for Lumbosacral Radicular Pain
Radicular Pain Related to Lumbosacral Disc Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Ten-Week, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of Milnacipran for Radicular Pain Associated With Lumbosacral Disk Disease|
- Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad) [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]The primary outcome is change in pain VAS from baseline through 10 weeks. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative total scores were reported.
- VAS Related to Nociceptive Pain Component (VAS-Noc) [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]The secondary outcome is change in pain VAS from baseline through 1o weeks as related to nociceptive pain component. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative scores were reported
- SF-36 (Short Form) [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
Self-report of quality of life. 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.
Scoring: Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores reflect higher quality of life with 100 high life quality. Total mean cumulative scores were reported
The eight sections are:
vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health
- Oswestry Low Back Pain Disability Questionnaire [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
Self report evaluation of various back pain symptoms. For each of 10 sections participants rate pain on a scale of 0-5 in these categories:
- Section 1 - Pain intensity
- Section 2 - Personal care
- Section 3 - Lifting
- Section 4 - Walking
- Section 5 - Sitting
- Section 6 - Standing
- Section 7 - Sleeping
- Section 8 - Sex life (if applicable)
- Section 9 - Social life
- Section 10 - Travelling
The scores are combined form each category into overall score. Scores are converted to percentages as follows:
0% to 20%: minimal disability: The patient can cope with most living activities.
21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing.
41%-60%: severe disability: Pain remains the main problem-activities of daily living are affected.
61%-80%: crippled: Back pain impinges on all aspects of life.
81%-100%: Patients are either bed-bound or exaggerating their symptoms
- Neuropathic Pain Questionnaire [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
Self-report evaluation of nerve pain symptoms. A low total cumulative score means less pain and higher cumulative score is greater pain.
Total cumulative scores range form 0 to 1000 where in 0 is absence of pain and 1000 highest pain.
- Beck Depression Inventory (BDI-II) [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
Self-report evaluation of depressive symptoms.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.
- State-trait Anxiety Inventory (STAI) [ Time Frame: baseline and 10 weeks ] [ Designated as safety issue: No ]
Self-report evaluation of anxiety symptoms.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
1= almost never 4= almost always
Higher scores indicate greater anxiety. Mean cumulative scores were reported
|Study Start Date:||March 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Milnacipran, flexibly dosed
Other Name: Savella
Placebo Comparator: Sugar pill (placebo)
The current study evaluates the potential efficacy of milnacipran in reducing lower extremity radicular pain associated with lumbar disk disease. Milnacipran will be titrated based on efficacy and tolerability aimed at the higher end of the therapeutic range; a recent study of a serotonin norepinephrine reuptake inhibitor in patients with osteoarthritis pain suggests efficacy may be dose related. Patients are likely to have concomitant nociceptive lower back pain, and cotreatment with opioids, muscle relaxants, benzodiazepines, or nonsteroidal anti-inflammatory drugs at stable doses will be permitted. Patients participating in stable regimen of physical therapy or biofeedback will be eligible. Procedural interventions (e.g. epidural steroid injection, nerve block, facet radioablation, acupuncture) during the study and 3 months prior will be exclusionary. Anticonvulsants, tramadol, and other antidepressant drugs will be excluded.
The study is a ten-week randomized, double-blind, placebo-controlled trial (RCT) of milnacipran (100-200 mg/day dosed twice a day) for radicular pain associated with lumbosacral disk disease.
Outcome measures and safety assessments will be obtained at weeks 1, 2, 4, 6, 8, and 10 according to the protocol schedule of assessments.
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