Low-Back Pain
Conditions
Keywords
Low-Back Pain, Neuropathic Pain, Pregabalin
Brief summary
The purpose of this study is to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.
Detailed description
Rational and background : The care for low back pain associated with neuropathic pain is a problem often encountered in daily outpatient. And the care effectiveness has been frequently evaluated by the patients directly, because the pain would be felt by patients themselves. On the view of those, we decided to investigate the clinical treatment outcome of pregabalin or other analgesics medication for relief of pain and improvement of sleep interference and QOLs by Patient-reported outcomes. Research question and objectives : To evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice. Study design: This is an 8-week, multicenter prospective observational study. Subjects who have chronic low back pain patients with accompanying lower limb pain (with a neuropathic component) and meet all other entry criteria are enrolled at baseline in the duration of study. The analgesic treatment is determined by the clinical judgment of the physician in charge of patient management. This therapeutic choice is not related to the decision to take part in the study. All enrolled subjects will be received with analgesic treatment. The study requires 3 visits at least, baseline/enrollment visit, Week 4 visit and Week 8 visit (or discontinuation).
Interventions
OTHERNo intervention
The study is observational
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject who received the enough study information and signed informed consent form. 2. Subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle. 3. Subject is male or female patient ≥18 years old. 4. Subject who has complained low back pain for 3 months or more before Visit 1. 5. Subject who is refractory to prior analgesics for 3 months and more. 6. Subject who is able and willing to complete all study related assessment and comply with the study schedule and clinical procedures at clinic. 7. Subject whose pain Numeric Rating Scale(NRS) ≥ 5 at baseline (based on recall over the past week)
Exclusion criteria
1. Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason. 2. Subject who has been already treated by pregabalin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) | Baseline, Final Visit (Week 8) | The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. Subjects are to describe how their pain has interfered with their sleep during the past week by choosing the appropriate number between 0 and 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score- | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) | The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function. |
| Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall) | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) | The Pain NRS (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects are asked to describe their average pain during the past week by choosing the appropriate number between 0 and 10. |
| Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score- | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) | The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. The Health State Profile is designed to record the subject's level of current health for five domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses from the five domains are used to calculate a single utility index value.; 1 indicates better health state (no problems); 5 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile; from 11111 to 55555. Score is transformed and results in a total score range -0.025 to 1.000; higher score indicates a better health state. |
| Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale - | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) | The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. There are two components to the EQ-5D-5L: A Health State Profile and a Visual Analogue Scale (VAS). Recent guidance suggests that the Health State Profile and VAS should be administered together. The Visual Analogue Scale (VAS) is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. |
| Clinical Global Impression of Change (CGIC) | Final Visit (Week8 or discontinuation) | The CGIC assessment includes one question (1-7 scale) inquiring about the subject's improvement considering their current disease state.; range from 1 (very much improved) to 7 (very much worse). |
| Patient Global Improvement of Change (PGIC) | Final Visit (Week8 or discontinuation) | The PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). |
| Work Productivity and Activity Impairment Scale (WPAI:LBP) | Final Visit (Week8 or discontinuation) | The WPAI: LBP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline. In this study, the WPAI: LBP will measure the effect of the patient's Chronic Low Back Pain (CLBP) with accompanying lower limb pain (neuropathic component) on work productivity and regular activities. |
| Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score- | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) | The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function. |
Other
| Measure | Time frame |
|---|---|
| Number of Patients With Adverse Events | Visit2(week4),Final Visit(Week8 or discontinuation) |
Countries
Japan
Participant flow
Recruitment details
The recruitment was conducted from Jun. 2014 to Dec. 2014 at 33 study sites.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Patients will be treated for 8 weeks with pregabalin in primary care :no intervention | 157 |
| Other Analgesics Patients will be treated for 8 weeks with other analgesics in usual care :no intervention | 174 |
| Total | 331 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 16 | 0 |
| Overall Study | Did not meet entrance criteria | 3 | 2 |
| Overall Study | Lost to Follow-up | 10 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Other Analgesics | Pregabalin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 130 Participants | 114 Participants | 244 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 43 Participants | 87 Participants |
| Age, Continuous | 70.7 years STANDARD_DEVIATION 12.17 | 69.1 years STANDARD_DEVIATION 14.12 | 70.0 years STANDARD_DEVIATION 13.13 |
| Region of Enrollment Japan | 174 participants | 157 participants | 331 participants |
| Sex: Female, Male Female | 106 Participants | 92 Participants | 198 Participants |
| Sex: Female, Male Male | 68 Participants | 65 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 157 |
| serious Total, serious adverse events | 0 / 157 |
Outcome results
Primary
Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. Subjects are to describe how their pain has interfered with their sleep during the past week by choosing the appropriate number between 0 and 10.
Time frame: Baseline, Final Visit (Week 8)
Population: Full Analysis Set; consisted of subjects who had at least one evaluable observation from any of the patient-reported outcomes, and only evaluable subjects who contributed to the particular outcome were evaluated in each analysis. 'n' signifies number of participants who were evaluable for specified categories at different time points
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) | Baseline (n=137,172) | 3.1 scores on a scale | Standard Error 2.63 |
| Pregabalin | Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) | Change from baseline at Week 8 (n=115,160) | -1.306 scores on a scale | Standard Error 0.197 |
| Other Analgesics | Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) | Baseline (n=137,172) | 2.9 scores on a scale | Standard Error 2.4 |
| Other Analgesics | Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) | Change from baseline at Week 8 (n=115,160) | -0.357 scores on a scale | Standard Error 0.168 |
p-value: <0.00195% CI: [-1.459, -0.439]Mixed Models Analysis
Secondary
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-
The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. The Health State Profile is designed to record the subject's level of current health for five domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses from the five domains are used to calculate a single utility index value.; 1 indicates better health state (no problems); 5 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile; from 11111 to 55555. Score is transformed and results in a total score range -0.025 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score- | Baseline (n=137,171) | 0.6647 units on a scale | Standard Error 0.1736 |
| Pregabalin | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score- | Change from baseline at Week 4 (n=118,158) | 0.0756 units on a scale | Standard Error 0.0103 |
| Pregabalin | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score- | Change from baseline at Week 8 (n=114,159) | 0.0804 units on a scale | Standard Error 0.0113 |
| Other Analgesics | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score- | Baseline (n=137,171) | 0.7233 units on a scale | Standard Error 0.1521 |
| Other Analgesics | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score- | Change from baseline at Week 4 (n=118,158) | 0.0427 units on a scale | Standard Error 0.0089 |
| Other Analgesics | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score- | Change from baseline at Week 8 (n=114,159) | 0.0600 units on a scale | Standard Error 0.0097 |
Comparison: Analysis on the mean difference between two groups with the change from baseline at Week 8.p-value: 0.17595% CI: [-0.0091, 0.0499]Mixed Models Analysis
Comparison: Analysis on the mean difference between two groups with the change from baseline at Week 4.p-value: 0.01795% CI: [0.0058, 0.06]Mixed Models Analysis
Secondary
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -
The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. There are two components to the EQ-5D-5L: A Health State Profile and a Visual Analogue Scale (VAS). Recent guidance suggests that the Health State Profile and VAS should be administered together. The Visual Analogue Scale (VAS) is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Time frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale - | Baseline (n=137,172) | 60.9 units on a scale | Standard Error 17.63 |
| Pregabalin | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale - | Change from baseline at Week 4 (n=118,159) | 2.633 units on a scale | Standard Error 1.373 |
| Pregabalin | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale - | Change from baseline at Week 8 (n=115,160) | 6.970 units on a scale | Standard Error 1.602 |
| Other Analgesics | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale - | Baseline (n=137,172) | 63.0 units on a scale | Standard Error 16.34 |
| Other Analgesics | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale - | Change from baseline at Week 4 (n=118,159) | 1.341 units on a scale | Standard Error 1.185 |
| Other Analgesics | Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale - | Change from baseline at Week 8 (n=115,160) | 2.272 units on a scale | Standard Error 1.364 |
Comparison: Analysis on the mean difference between two groups with the change from baseline at Week 8.p-value: 0.02695% CI: [0.552, 8.842]Mixed Models Analysis
Comparison: Analysis on the mean difference between two groups with the change from baseline at Week 4.p-value: 0.47795% CI: [-2.282, 4.866]Mixed Models Analysis
Secondary
Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)
The Pain NRS (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects are asked to describe their average pain during the past week by choosing the appropriate number between 0 and 10.
Time frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall) | Baseline (n=137,172) | 6.2 scores on a scale | Standard Error 1.17 |
| Pregabalin | Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall) | Change from baseline at Week 4 (n=118,160) | 1.763 scores on a scale | Standard Error 0.172 |
| Pregabalin | Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall) | Change from baseline at Week 8 (n=115,160) | -2.166 scores on a scale | Standard Error 0.181 |
| Other Analgesics | Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall) | Baseline (n=137,172) | 5.8 scores on a scale | Standard Error 1.14 |
| Other Analgesics | Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall) | Change from baseline at Week 4 (n=118,160) | -1.089 scores on a scale | Standard Error 0.149 |
| Other Analgesics | Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall) | Change from baseline at Week 8 (n=115,160) | -1.336 scores on a scale | Standard Error 0.155 |
Comparison: Analysis on the mean difference between two groups with the change from baseline at Week 8.p-value: <0.00195% CI: [-1.301, -0.359]Mixed Models Analysis
Comparison: Analysis on the mean difference between two groups with the change from baseline at Week 4.p-value: 0.00495% CI: [-1.125, -0.223]Mixed Models Analysis
Secondary
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-
The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.
Time frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score- | Baseline (n=113,138) | 39.77 scores on a scale | Standard Error 12.453 |
| Pregabalin | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score- | Change from baseline at Week 4 (n=97,128) | 5.1062 scores on a scale | Standard Error 0.6905 |
| Pregabalin | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score- | Change from baseline at Week 8 (n=99,127) | 6.8377 scores on a scale | Standard Error 0.6833 |
| Other Analgesics | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score- | Baseline (n=113,138) | 44.92 scores on a scale | Standard Error 9.845 |
| Other Analgesics | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score- | Change from baseline at Week 4 (n=97,128) | 2.3772 scores on a scale | Standard Error 0.6039 |
| Other Analgesics | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score- | Change from baseline at Week 8 (n=99,127) | 3.5359 scores on a scale | Standard Error 0.604 |
Comparison: Analysis on the mean difference between two groups with the change from baseline at Week 8.p-value: <0.00195% CI: [1.4903, 5.1133]Mixed Models Analysis
Comparison: Analysis on the mean difference between two groups with the change from baseline at Week 4.p-value: 0.00495% CI: [0.9047, 4.5533]Mixed Models Analysis
Secondary
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-
The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.
Time frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score- | Baseline (n=137,172) | 10.8 scores on a scale | Standard Error 5.2 |
| Pregabalin | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score- | Change from baseline at Week 4(n=118,160) | -2.893 scores on a scale | Standard Error 0.312 |
| Pregabalin | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score- | Change from baseline at Week 8 (n=115,160) | -3.670 scores on a scale | Standard Error 0.335 |
| Other Analgesics | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score- | Baseline (n=137,172) | 9.1 scores on a scale | Standard Error 4.9 |
| Other Analgesics | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score- | Change from baseline at Week 4(n=118,160) | -1.006 scores on a scale | Standard Error 0.27 |
| Other Analgesics | Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score- | Change from baseline at Week 8 (n=115,160) | -1.411 scores on a scale | Standard Error 0.287 |
Comparison: Analysis on the mean difference between two groups with the change from baseline at Week 8.p-value: <0.00195% CI: [-3.131, -1.387]Mixed Models Analysis
Comparison: Analysis on the mean difference between two groups with the change from baseline at Week 4.p-value: <0.00195% CI: [-2.704, -1.071]Mixed Models Analysis
Secondary
Clinical Global Impression of Change (CGIC)
The CGIC assessment includes one question (1-7 scale) inquiring about the subject's improvement considering their current disease state.; range from 1 (very much improved) to 7 (very much worse).
Time frame: Final Visit (Week8 or discontinuation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Clinical Global Impression of Change (CGIC) | 3.Minimally improved | 37 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | 5.Minimally worse | 0 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | 2.Much improved | 47 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | 6.Much worse | 0 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | 4.No change | 24 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | 7.Very much worse | 0 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | 1.Very much improved | 17 participants |
| Other Analgesics | Clinical Global Impression of Change (CGIC) | 7.Very much worse | 0 participants |
| Other Analgesics | Clinical Global Impression of Change (CGIC) | 1.Very much improved | 3 participants |
| Other Analgesics | Clinical Global Impression of Change (CGIC) | 2.Much improved | 24 participants |
| Other Analgesics | Clinical Global Impression of Change (CGIC) | 3.Minimally improved | 47 participants |
| Other Analgesics | Clinical Global Impression of Change (CGIC) | 4.No change | 79 participants |
| Other Analgesics | Clinical Global Impression of Change (CGIC) | 5.Minimally worse | 9 participants |
| Other Analgesics | Clinical Global Impression of Change (CGIC) | 6.Much worse | 1 participants |
p-value: <0.001Modified Chi-squared
Secondary
Patient Global Improvement of Change (PGIC)
The PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).
Time frame: Final Visit (Week8 or discontinuation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Patient Global Improvement of Change (PGIC) | 3.Minimally improved | 45 participants |
| Pregabalin | Patient Global Improvement of Change (PGIC) | 4.No change | 27 participants |
| Pregabalin | Patient Global Improvement of Change (PGIC) | 5.Minimally worse | 3 participants |
| Pregabalin | Patient Global Improvement of Change (PGIC) | 6.Much worse | 0 participants |
| Pregabalin | Patient Global Improvement of Change (PGIC) | 7.Very much worse | 0 participants |
| Pregabalin | Patient Global Improvement of Change (PGIC) | 1.Very much improved | 8 participants |
| Pregabalin | Patient Global Improvement of Change (PGIC) | 2.Much improved | 34 participants |
| Other Analgesics | Patient Global Improvement of Change (PGIC) | 3.Minimally improved | 44 participants |
| Other Analgesics | Patient Global Improvement of Change (PGIC) | 7.Very much worse | 1 participants |
| Other Analgesics | Patient Global Improvement of Change (PGIC) | 4.No change | 71 participants |
| Other Analgesics | Patient Global Improvement of Change (PGIC) | 2.Much improved | 22 participants |
| Other Analgesics | Patient Global Improvement of Change (PGIC) | 5.Minimally worse | 17 participants |
| Other Analgesics | Patient Global Improvement of Change (PGIC) | 1.Very much improved | 5 participants |
| Other Analgesics | Patient Global Improvement of Change (PGIC) | 6.Much worse | 1 participants |
p-value: <0.001Modified Chi-squared
Secondary
Work Productivity and Activity Impairment Scale (WPAI:LBP)
The WPAI: LBP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline. In this study, the WPAI: LBP will measure the effect of the patient's Chronic Low Back Pain (CLBP) with accompanying lower limb pain (neuropathic component) on work productivity and regular activities.
Time frame: Final Visit (Week8 or discontinuation)
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Work Productivity and Activity Impairment Scale (WPAI:LBP) | 1.PWP (n=43, 56) | 0.13 percentage of time missed | Standard Deviation 0.863 |
| Pregabalin | Work Productivity and Activity Impairment Scale (WPAI:LBP) | 2.PWI (n=43, 55) | 28.84 percentage of time missed | Standard Deviation 23.726 |
| Pregabalin | Work Productivity and Activity Impairment Scale (WPAI:LBP) | 3.PWPI (n=43, 55) | 28.88 percentage of time missed | Standard Deviation 23.797 |
| Pregabalin | Work Productivity and Activity Impairment Scale (WPAI:LBP) | 4.PAI (n=42, 56) | 31.19 percentage of time missed | Standard Deviation 26.152 |
| Other Analgesics | Work Productivity and Activity Impairment Scale (WPAI:LBP) | 4.PAI (n=42, 56) | 29.64 percentage of time missed | Standard Deviation 23.039 |
| Other Analgesics | Work Productivity and Activity Impairment Scale (WPAI:LBP) | 1.PWP (n=43, 56) | 1.61 percentage of time missed | Standard Deviation 7.574 |
| Other Analgesics | Work Productivity and Activity Impairment Scale (WPAI:LBP) | 3.PWPI (n=43, 55) | 27.84 percentage of time missed | Standard Deviation 25.814 |
| Other Analgesics | Work Productivity and Activity Impairment Scale (WPAI:LBP) | 2.PWI (n=43, 55) | 27.09 percentage of time missed | Standard Deviation 24.771 |
Other Pre-specified
Number of Patients With Adverse Events
Time frame: Visit2(week4),Final Visit(Week8 or discontinuation)
Population: Safety Analysis Set; All subjects who received at least one dose of pregabalin. The primary objectives of this study did not include comparison of safety with usual care, consistent with the non-interventional nature of the study. Therefore, adverse events were not collected from the participants in usual care.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin | Number of Patients With Adverse Events | 56 participants of related AEs |