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| ID | Type | Description | Link |
|---|---|---|---|
| SAV-MD-12 |
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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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This study investigates whether milnacipran reduces radicular pain ("sciatica") in patients with lumbosacral disc disease.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| milnacipran | Experimental | Milnacipran, flexibly dosed |
|
| Sugar pill (placebo) | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milnacipran | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad) | 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. | baseline and 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| VAS Related to Nociceptive Pain Component (VAS-Noc) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25664215 | Derived | Marks DM, Pae CU, Patkar AA. A double-blind, placebo-controlled, parallel-group pilot study of milnacipran for chronic radicular pain (sciatica) associated with lumbosacral disc disease. Prim Care Companion CNS Disord. 2014 Aug 14;16(4):10.4088/PCC.14m01658. doi: 10.4088/PCC.14m01658. eCollection 2014. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Milnacipran | Milnacipran, flexibly dosed |
| FG001 | Sugar Pill (Placebo) | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two subjects were screened/consented but not assigned to either arm patient. These two patients are reflected as one that would have been assigned to each arm. These subjects were did not receive inerventons
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| ID | Title | Description |
|---|---|---|
| BG000 | Milnacipran | Milnacipran, flexibly dosed 100-200 mg/day dosed twice a day |
| BG001 | Sugar Pill (Placebo) | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 10 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Milnacipran | Milnacipran, flexibly dosed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Marks, MD | Duke University Medical Center | 919 668-2859 | d.marks@duke.edu |
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| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| ID | Term |
|---|---|
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
|
| baseline and 10 weeks |
| SF-36 (Short Form) | 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 | baseline and 10 weeks |
| Oswestry Low Back Pain Disability Questionnaire | 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:
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 | baseline and 10 weeks |
| Neuropathic Pain Questionnaire | 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. | baseline and 10 weeks |
| Beck Depression Inventory (BDI-II) | 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. | baseline and 10 weeks |
| State-trait Anxiety Inventory (STAI) | 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 Scale 1= almost never 4= almost always Higher scores indicate greater anxiety. Mean cumulative scores were reported | baseline and 10 weeks |
| Lack of Efficacy |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | VAS Related to Nociceptive Pain Component (VAS-Noc) | 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 | Posted | Mean | Standard Deviation | units on a scale | baseline and 10 weeks |
|
|
|
| Secondary | SF-36 (Short Form) | 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 | Posted | Mean | Standard Deviation | units on a scale | baseline and 10 weeks |
|
|
|
| Secondary | Oswestry Low Back Pain Disability Questionnaire | 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:
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 | Posted | Mean | Standard Deviation | percent score | baseline and 10 weeks |
|
|
|
| Secondary | Neuropathic Pain Questionnaire | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 10 weeks |
|
|
|
| Secondary | Beck Depression Inventory (BDI-II) | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline and 10 weeks |
|
|
|
| Secondary | State-trait Anxiety Inventory (STAI) | 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 Scale 1= almost never 4= almost always Higher scores indicate greater anxiety. Mean cumulative scores were reported | Posted | Mean | Standard Deviation | units on a scale | baseline and 10 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Sugar Pill (Placebo) | Placebo | 0 | 4 | 0 | 4 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |