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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Patients will be treated for 8 weeks with pregabalin in primary care: no intervention |
| |
| Usual care | Patients will be treated for 8 weeks with other analgesics in usual care: no intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | The study is observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Final Visit (Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adverse Events | Visit2(week4),Final Visit(Week8 or discontinuation) |
Inclusion Criteria:
Exclusion Criteria:
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Chronic low-back pain patients with neuropathic component will be treated with pregabalin or other analgesics
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| Name | Affiliation | Role |
|---|---|---|
| Koichi Fujii, MD | Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kimura Clinic | Nagoya | Aichi-ken | Japan | |||
| Jin Orthopaedic Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26346468 | Result | Taguchi T, Igarashi A, Watt S, Parsons B, Sadosky A, Nozawa K, Hayakawa K, Yoshiyama T, Ebata N, Fujii K. Effectiveness of pregabalin for the treatment of chronic low back pain with accompanying lower limb pain (neuropathic component): a non-interventional study in Japan. J Pain Res. 2015 Aug 5;8:487-97. doi: 10.2147/JPR.S88642. eCollection 2015. |
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The recruitment was conducted from Jun. 2014 to Dec. 2014 at 33 study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Patients will be treated for 8 weeks with pregabalin in primary care:no intervention |
| FG001 | Other Analgesics | Patients will be treated for 8 weeks with other analgesics in usual care:no intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) |
| 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. | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) |
| 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. | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) |
| 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. | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) |
| 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). | Final Visit (Week8 or discontinuation) |
| 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). | Final Visit (Week8 or discontinuation) |
| 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. | Final Visit (Week8 or discontinuation) |
| Ichikawa |
| Chiba |
| 272-0133 |
| Japan |
| Satoh Orthopaedic Clinic | Ichikawa | Chiba | Japan |
| Shiraishi Orthopaedic Clinic | Ichikawa | Chiba | Japan |
| Ota General Hospital | Kawasaki | Kanagawa | Japan |
| Aoki Orthpaedic Clinic | Sagamihara | Kanagawa | Japan |
| Hiyoshi Hocho Clinic | Yokohama | Kanagawa | Japan |
| Yamamoto Memorial Hospital | Yokohama | Kanagawa | Japan |
| Ageo Medical Clinic | Ageo | Saitama | Japan |
| Arai Orthopaedic Clinic | Fujimino | Saitama | Japan |
| Nakaicho Clinic | Adachi City | Tokyo | Japan |
| Mitsuda Orthopaedic Clinic | Chiyoda City | Tokyo | Japan |
| Kyobashi Orthopaedic Clinic | Chūō | Tokyo | Japan |
| Morishima Clinic | Edogawa City | Tokyo | Japan |
| Kita Akabane Orthopaedic Clinic | Kita-ku | Tokyo | Japan |
| Takeuchi Orthopaedic Clinic | Kita-ku | Tokyo | Japan |
| Tanaka Orthopaedic Clinic | Koganei | Tokyo | Japan |
| Araki Clinic | Koto | Tokyo | Japan |
| Kohsei Chuo General Hospital | Meguro City | Tokyo | Japan |
| Meguro Seikeigeka Naika | Meguro City | Tokyo | Japan |
| Meguro Yuai Clinic | Meguro City | Tokyo | Japan |
| Takemoto Orthopaedic Clinic | Ohta | Tokyo | Japan |
| Shiotani Pain Clinic | Shinagawa | Tokyo | Japan |
| Daido Hospital | Toshima City | Tokyo | Japan |
| Senkawa Shinoda Orthopaedic Clinic | Toshima City | Tokyo | Japan |
| Takahashi Orthopaedic Clinic | Toshima City | Tokyo | Japan |
| Kanazawa Hospital | Kanazawa | Yokohama | Japan |
| Katayama Orthopaedic Memorial Hospital | Tsurumi | Yokohama | Japan |
| Nakamura Orthopaedic Clinic | Kagoshima | Japan |
| Showa-kai Clinic | Kagoshima | Japan |
| Clinic Ushitani | Miyazaki | Japan |
| Kohnan Matsumoto Orthopaedic Clinic | Miyazaki | Japan |
| Iwasaki Orthopaedic Clinic | Saitama | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Patients will be treated for 8 weeks with pregabalin in primary care :no intervention |
| BG001 | Other Analgesics | Patients will be treated for 8 weeks with other analgesics in usual care :no intervention |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | 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. | 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 | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Final Visit (Week 8) |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) |
|
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| 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. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) |
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| 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. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) |
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| 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. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation) |
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| 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). | Full Analysis Set | Posted | Number | participants | Final Visit (Week8 or discontinuation) |
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| 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). | Full Analysis Set | Posted | Number | participants | Final Visit (Week8 or discontinuation) |
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| 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. | Full Analysis Set | Posted | Mean | Standard Deviation | percentage of time missed | Final Visit (Week8 or discontinuation) |
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| Other Pre-specified | Number of Patients With Adverse Events | 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. | Posted | Number | participants of related AEs | Visit2(week4),Final Visit(Week8 or discontinuation) |
|
|
Baseline to Week 4, Week 8
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.
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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 | Pregabalin | Patients will be treated for 8 weeks with pregabalin in primary care No intervention: The study is observational | 0 | 157 | 40 | 157 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director : Koichi Fujii, MD | Medical Affairs, Pfizer Japan Inc. | 81-3-5309-9370 | koichi.fujii@pfizer.com |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| >=65 years |
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| Male |
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