A Study for Patient With Chronic Low Back Pain

• Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
• Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients completed the electronic diary at bedtime. The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means. Least Squares Mean values were controlled for investigator and baseline severity.
• Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.
• Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score. BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Response was assessed at endpoint.
• Number of Sustained Responders at 12 Week Endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit. BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of sustained responders was assessed at endpoint.
• Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction. The thresholds are given as percent reductions in BPI average pain score from the baseline score. BPI: a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Number of participants under each threshold was assessed at endpoint.
• Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  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). Least Squares Mean values were controlled for investigator and baseline severity.
• Patient's Global Impression of Improvement (PGI-I) at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  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). Least Squares Mean values were controlled for investigator and baseline severity.
• Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Least Squares Mean values were controlled for investigator and baseline severity.
• Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig). Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).
• Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  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]). The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).
• Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  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 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient. Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.
• Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI) [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]

  WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

  1. Absenteeism
  2. Presenteeism
  3. Work productivity loss
  4. Activity Impairment Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment.
• Participants Who Discontinued From Baseline to 12 Weeks [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Reasons for discontinuation are listed in the participant flow.
• Change From Baseline to 12 Weeks in Uric Acid [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Least Squares Mean values were controlled for investigator.
• Change From Baseline to 12 Week Endpoint in Albumin [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Least Squares Mean values were controlled for investigator.
• Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Least Squares Mean values were controlled for investigator.
• Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Least Squares Mean values were controlled for investigator.
• Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Least Squares Mean values were controlled for investigator.
• Change From Baseline to 12 Week Endpoint in Creatinine [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Least Squares Mean values were controlled for investigator.
• Change From Baseline to 12 Week Endpoint in Total Protein [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Least Squares Mean values were controlled for investigator.
• Change From Baseline to 12 Weeks in Blood Pressure [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Least Squares Mean values were controlled for investigator.
• Change From Baseline to 12 Week Endpoint in Weight [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Least Squares Mean values were controlled for investigator.
• Change From Baseline to 12 Week Endpoint in Pulse Rate [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  Least Squares Mean values were controlled for investigator.
• Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale [ Time Frame: baseline through 12 weeks ] [ Designated as safety issue: Yes ]
  The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.

• Brief Pain Inventory - Severity and Interference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Weekly mean of 24-hour average pain rating using an 11-point numerical scale patient diary [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Response to treatment - ≥ 30% reduction of the BPI average pain severity rating [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Response to treatment - ≥ 50% reduction of the BPI average pain severity rating [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Sustained response to treatment - ≥ 30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and maintains a ≥ 20% reduction of BPI average pain rating from baseline at every visit [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Cumulative distribution of BPI average pain score reduction, as measured by the percentage of patients who have reached each threshold of BPI average pain reduction from baseline to baseline-carried-forward endpoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Clinical Global Impressions of Severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Patient's Global Impression of Improvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Roland Morris Disability Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Profile of Mood States - Brief Form [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• 36-item Short-Form Health Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• European Quality of Life Questionnaire - 5 Dimension [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Work Productivity and Activity Impairment Instrument [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Discontinuation rates [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Treatment-emergent adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Laboratory assessments [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Vital signs and weight [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
• Columbia Suicide Severity Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.

• Drug: Duloxetine
  60 mg orally once daily for 12 weeks
  Other Names:

  • Cymbalta
  • LY248686
• Drug: Placebo
  Placebo once daily orally for 12 weeks

• Experimental: Duloxetine
  Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
  Intervention: Drug: Duloxetine
• Placebo Comparator: Placebo
  Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
  Intervention: Drug: Placebo

Inclusion Criteria:

• Male or female outpatients with chronic low back pain

Exclusion Criteria:

• Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
• Acute liver injury (such as hepatitis) or severe cirrhosis.
• Previous exposure to duloxetine.
• Body Mass Index (BMI) over 40.
• Major depressive disorder.
• Daily use of narcotics.