Low-Back PainPRONCT02273908
PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin
An observational study of Low-Back Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low-Back Pain
- How many people
- 331 participants
- Where
- 33 sitesJapan
- Study dates
- Jul 2014to Mar 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic low-back pain patients with neuropathic component will be treated with pregabalin or other analgesics
Who may be able to join
- Subject who received the enough study information and signed informed consent form.
- Subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle.
- Subject is male or female patient ≥18 years old.
- Subject who has complained low back pain for 3 months or more before Visit 1.
- Subject who is refractory to prior analgesics for 3 months and more.
- Subject who is able and willing to complete all study related assessment and comply with the study schedule and clinical procedures at clinic.
- Subject whose pain Numeric Rating Scale(NRS) ≥ 5 at baseline (based on recall over the past week)
Who cannot join
- Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.
- Subject who has been already treated by pregabalin
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Japan33 sites
Nakaicho Clinic
Adachi City, Tokyo
Ageo Medical Clinic
Ageo, Saitama
Mitsuda Orthopaedic Clinic
Chiyoda City, Tokyo
Kyobashi Orthopaedic Clinic
Chūō, Tokyo
Morishima Clinic
Edogawa City, Tokyo
Arai Orthopaedic Clinic
Fujimino, Saitama
Jin Orthopaedic Clinic
Ichikawa, Chiba, 272-0133
Satoh Orthopaedic Clinic
Ichikawa, Chiba
Shiraishi Orthopaedic Clinic
Ichikawa, Chiba
Nakamura Orthopaedic Clinic
Kagoshima
Showa-kai Clinic
Kagoshima
Kanazawa Hospital
Kanazawa, Yokohama
Ota General Hospital
Kawasaki, Kanagawa
Kita Akabane Orthopaedic Clinic
Kita-ku, Tokyo
Takeuchi Orthopaedic Clinic
Kita-ku, Tokyo
Tanaka Orthopaedic Clinic
Koganei, Tokyo
Araki Clinic
Koto, Tokyo
Kohsei Chuo General Hospital
Meguro City, Tokyo
Meguro Seikeigeka Naika
Meguro City, Tokyo
Meguro Yuai Clinic
Meguro City, Tokyo
Clinic Ushitani
Miyazaki
Kohnan Matsumoto Orthopaedic Clinic
Miyazaki
Kimura Clinic
Nagoya, Aichi-ken
Takemoto Orthopaedic Clinic
Ohta, Tokyo
Aoki Orthpaedic Clinic
Sagamihara, Kanagawa
Iwasaki Orthopaedic Clinic
Saitama
Shiotani Pain Clinic
Shinagawa, Tokyo
Daido Hospital
Toshima City, Tokyo
Senkawa Shinoda Orthopaedic Clinic
Toshima City, Tokyo
Takahashi Orthopaedic Clinic
Toshima City, Tokyo
Katayama Orthopaedic Memorial Hospital
Tsurumi, Yokohama
Hiyoshi Hocho Clinic
Yokohama, Kanagawa
Yamamoto Memorial Hospital
Yokohama, Kanagawa
About this study
Official title: Patient-reported-outcomes(PROs) in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin in Primary Care Settings
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.
Read the 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).
- Conditions
- Low-Back Pain
- Being tested
- No intervention
- Keywords
- Low-Back Pain, Neuropathic Pain, Pregabalin
- Medical subject headings
- Low Back Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
The study is observational
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Patients will be treated for 8 weeks with pregabalin in primary care: no intervention Receives: Other: No intervention | |
| Usual care | Patients will be treated for 8 weeks with other analgesics in usual care: no intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Final Visit (Week 8)
Secondary outcomes (8)
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.
Measured: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Final Visit (Week8 or discontinuation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low-Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Koichi Fujii, MD, Study director, Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273908
- Sponsor's protocol ID
- A0081333
- Acronym
- PRO
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2014
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26346468
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported-outcomes(PROs) in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin in Primary Care Settings
- ClinicalTrials.gov ID
- NCT02273908
- Acronym / sponsor ID
- PRO / A0081333
- Conditions
- Low-Back Pain
- Keywords
- Low-Back Pain, Neuropathic Pain, Pregabalin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Posted 6 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | – | Other: No interventionPatients will be treated for 8 weeks with pregabalin in primary care: no intervention |
| Usual care | – | Other: No interventionPatients will be treated for 8 weeks with other analgesics in usual care: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic low-back pain patients with neuropathic component will be treated with pregabalin or other analgesics
Key inclusion criteria (7 listed)
- Subject who received the enough study information and signed informed consent form.
- Subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle.
- Subject is male or female patient ≥18 years old.
- Subject who has complained low back pain for 3 months or more before Visit 1.
- Subject who is refractory to prior analgesics for 3 months and more.
Key exclusion criteria (2 listed)
- Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.
- Subject who has been already treated by pregabalin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThe study is observational | Other | Pregabalin, Usual care |
Primary outcome
Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
Time frame: 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.
8 secondary outcomes
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-
Time frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-
Time frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)
Time frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-
Time frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -
Time frame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Clinical Global Impression of Change (CGIC)
Time frame: Final Visit (Week8 or discontinuation)
Patient Global Improvement of Change (PGIC)
Time frame: Final Visit (Week8 or discontinuation)
Work Productivity and Activity Impairment Scale (WPAI:LBP)
Time frame: Final Visit (Week8 or discontinuation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26346468Taguchi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koichi Fujii, MD study director
Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low-Back Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) (time frame: Baseline, Final Visit (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02273908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.