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PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin (PRO)

15. januar 2021 opdateret af: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

331

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Kagoshima, Japan
        • Nakamura Orthopaedic Clinic
      • Kagoshima, Japan
        • Showa-kai Clinic
      • Miyazaki, Japan
        • Clinic Ushitani
      • Miyazaki, Japan
        • Kohnan Matsumoto Orthopaedic Clinic
      • Saitama, Japan
        • Iwasaki Orthopaedic Clinic
    • Aichi
      • Nagoya, Aichi, Japan
        • Kimura Clinic
    • Chiba
      • Ichikawa, Chiba, Japan, 272-0133
        • Jin Orthopaedic Clinic
      • Ichikawa, Chiba, Japan
        • Satoh Orthopaedic Clinic
      • Ichikawa, Chiba, Japan
        • Shiraishi Orthopaedic Clinic
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
        • Ota General Hospital
      • Sagamihara, Kanagawa, Japan
        • Aoki Orthpaedic Clinic
      • Yokohama, Kanagawa, Japan
        • Hiyoshi Hocho Clinic
      • Yokohama, Kanagawa, Japan
        • Yamamoto Memorial Hospital
    • Saitama
      • Ageo, Saitama, Japan
        • Ageo Medical Clinic
      • Fujimino, Saitama, Japan
        • Arai Orthopaedic Clinic
    • Tokyo
      • Adachi, Tokyo, Japan
        • Nakaicho Clinic
      • Chiyoda, Tokyo, Japan
        • Mitsuda Orthopaedic Clinic
      • Chuo, Tokyo, Japan
        • Kyobashi Orthopaedic Clinic
      • Edogawa, Tokyo, Japan
        • Morishima Clinic
      • Kita, Tokyo, Japan
        • Kita Akabane Orthopaedic Clinic
      • Kita, Tokyo, Japan
        • Takeuchi Orthopaedic Clinic
      • Koganei, Tokyo, Japan
        • Tanaka Orthopaedic Clinic
      • Koto, Tokyo, Japan
        • Araki Clinic
      • Meguro, Tokyo, Japan
        • Kohsei Chuo General Hospital
      • Meguro, Tokyo, Japan
        • Meguro Seikeigeka Naika
      • Meguro, Tokyo, Japan
        • Meguro Yuai Clinic
      • Ohta, Tokyo, Japan
        • Takemoto Orthopaedic Clinic
      • Shinagawa, Tokyo, Japan
        • Shiotani Pain Clinic
      • Toshima, Tokyo, Japan
        • Daido Hospital
      • Toshima, Tokyo, Japan
        • Senkawa Shinoda Orthopaedic Clinic
      • Toshima, Tokyo, Japan
        • Takahashi Orthopaedic Clinic
    • Yokohama
      • Kanazawa, Yokohama, Japan
        • Kanazawa Hospital
      • Tsurumi, Yokohama, Japan
        • Katayama Orthopaedic Memorial Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Chronic low-back pain patients with neuropathic component will be treated with pregabalin or other analgesics

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Andet
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Pregabalin
Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
Andet: No intervention
The study is observational
Usual care
Patients will be treated for 8 weeks with other analgesics in usual care: no intervention
Andet: No intervention
The study is observational

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
Tidsramme: 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.
Baseline, Final Visit (Week 8)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-
Tidsramme: 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.
Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-
Tidsramme: 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.
Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)
Tidsramme: 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.
Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-
Tidsramme: 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.
Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -
Tidsramme: 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.
Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Clinical Global Impression of Change (CGIC)
Tidsramme: 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).
Final Visit (Week8 or discontinuation)
Patient Global Improvement of Change (PGIC)
Tidsramme: 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).
Final Visit (Week8 or discontinuation)
Work Productivity and Activity Impairment Scale (WPAI:LBP)
Tidsramme: 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.
Final Visit (Week8 or discontinuation)

Andre resultatmål

Resultatmål
Tidsramme
Number of Patients With Adverse Events
Tidsramme: Visit2(week4),Final Visit(Week8 or discontinuation)
Visit2(week4),Final Visit(Week8 or discontinuation)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Efterforskere

  • Studieleder: Koichi Fujii, MD, Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2014

Primær færdiggørelse (Faktiske)

1. februar 2015

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

17. oktober 2014

Først indsendt, der opfyldte QC-kriterier

21. oktober 2014

Først opslået (Skøn)

24. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. januar 2021

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A0081333

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Low-Back Pain

Kliniske forsøg med No intervention

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