Duloxetine Versus Placebo in Chronic Low Back Pain

Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint

A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

Time frame: Week 13

Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score

Roland-Morris questionnaire was completed by the patient and measured the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient was instructed to put a mark next to each appropriate statement. The number of statements marked was added up by the clinician and a total score was given. The total score ranges from 0 (no disability) to 24 (severe disability).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score

The 11-point Likert scale was used for assessment of 24-hour night pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score

The 11-point Likert scale was used for assessment of 24-hour worst pain and evaluated as weekly means. Scores range from from 0 (no pain) to 10 (worst possible pain).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score

A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score

A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score

A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity

A self-reported scale that measures the interference of pain in the past 24 hours on general acitivity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood

A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability

A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work

A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People

A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep

A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life

A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference

A self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The average Interference scores range from 0 (does not interfere) to 10 (completely interferes).

Time frame: Baseline, Week 13

Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward

Time frame: Baseline to Week 13

Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward

Time frame: Baseline to Week 13

Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale

Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Bodily pain scores range from 2-11 (higher scores indicate better health status).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). General health scores range from 5-25(higher scores indicate better health status).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Mental health scores range from 5-30 (higher scores indicate better health status).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Physical functioning scores range from 10-30 (higher scores indicate better health status).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Role-emotional scores range from 3-6 (higher scores indicate better health status).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Role-physical scores range from 4-8 (higher scores indicate better health status).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Social functioning scores range from 2-10 (higher scores indicate better health status).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality

The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). Vitality scores range from 4-24 (higher scores indicate better health status).

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score

The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient.

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score

A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale

A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'

Time frame: Baseline, Week 13

Adverse Events Reported as Reason for Discontinuation

Time frame: Baseline to Week 13

Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase

Time frame: Baseline, Week 13

Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure

Time frame: Baseline, Week 13

Change From Baseline to Week 13 Endpoint in Vital Signs - Weight

Time frame: Baseline, Week 13