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PROs in Chronic Cervical Pain Patients With Accompanying Upper Limb Radiating Pain Treated With Pregabalin

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

PATIENT-REPORTED-OUTCOMES IN CHRONIC CERVICAL PAIN PATIENTS WITH ACCOMPANYING UPPER LIMB RADIATING PAIN (NEUROPATHIC COMPONENT) TREATED WITH PREGABALIN IN PRIMARY CARE SETTINGS

The purpose of this study is to evaluate the effect of pregabalin on patient reported outcomes compared with conventional analgesic care in chronic cervical pain patients with accompanying upper limb radiating pain (neuropathic component) treated in primary care settings under routine clinical practice.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Rational and background:

Cervical pain with upper limb radiating pain(neuropathic component), such as cervical spondylosis radiculopathy or cervical spondylotic myelopathy, is one of the typical and common neuropathic pain. However, in Japan, large number of those patients are treated with NSAIDs without adequately assessing the cause of pain, despite that α2δ ligand, SNRI (Serotonin and Norepinephrine Reuptake Inhibitors ), and TCA (Tricyclic Antidepressants) are recommended in the clinical guidelines for neuropathic pain. Therefore, treatment satisfaction of these patients is low. This is currently a major issue in treatment for cervical pain with neuropathic component in Japan. In fact, our previous study which assessed the effect of pregabalin in low back pain patients with radiculopathy suggested that the selection of appropriate analgesics according to the cause of pain improved pain related sleep interference, pain and function. However, there are a few reports with regard to effect of pregabalin in cervical pain patients with neuropathic component. Therefore, we propose to conduct an observational study in order to assess the effects of pregabalin in cervical radiculopathy, when added to routine clinical care. The present study can encourage an understanding of the necessary of assessing cause of the pain, and treating with appropriate analgesics.

Research objectives :

To evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic cervical pain patients with accompanying upper limb radiating pain(neuropathic component) treated in primary care settings under routine clinical practice.

Study design:

This is an 8-week, multicenter prospective non-interventional observational study. Subjects who have chronic cervical radiating pain patients with accompanying upper limb radiating pain (with a neuropathic component) and meet all other entry criteria are enrolled at baseline in the duration of study. Study arms are pregabalin with or without usual care vs. usual care (mono/combo therapy). The usual care are assumed NSAIDs, Antidepressants, weak opioids, acetaminophen etc.

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).

Studietype

Observasjonsmessig

Registrering (Faktiske)

369

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Japan
      • Fukusima, Japan, 960-8251
        • Fukushima Daiichi Hospital
      • Saga, Japan, 840-8571
        • Saga-Ken Medical Center Koseikan
      • Tokyo, Japan, 104-0031
        • Tokyo Rheumatism Pain Clinic
    • Chiba
      • Ichikawa, Chiba, Japan, 272-0021
        • Satoh Orthopaedic Clinic
      • Ichikawa, Chiba, Japan, 272-0138
        • Shiraishi Orthopaedic Clinic
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 813-8501
        • Chihaya Hospital
      • Fukuokashi, Fukuoka, Japan, 810-0022
        • Clinic for Sports Medicine and Nutrition
      • Fukuokashi, Fukuoka, Japan, 812-0041
        • Seiwa Orthopedics Surgery Internal Medicine
      • Fukuokashi, Fukuoka, Japan, 812-0046
        • Kiheikai Yoh Orthopedic Clinic
      • Higashi-ku,Fukuoka, Fukuoka, Japan, 813-0017
        • Fukuoka Mirai Hospital
      • Kitakyusyu-shi, Fukuoka, Japan, 800-0057
        • Shin Komonji Hospital
    • Gunma
      • Takasaki-shi, Gunma, Japan, 370-0035
        • Takasaki Pain Clinic
    • Hokkaido
      • Sapporoshi, Hokkaido, Japan, 064-8570
        • Miyanomori Memorial Hospital
    • Hyogo
      • Himeji-shi, Hyogo, Japan, 670-0976
        • Oomuro Orthopedic Clinic
      • Kako-gun, Hyogo, Japan, 675-1115
        • Oonishi Medical Clinic
      • Kobe, Hyogo, Japan, 657-0824
        • Watanabe Orthopaedic Clinic
    • Kanagawa
      • Fujisawa-shi, Kanagawa, Japan, 252-0802
        • Fujisawa Shonandai Hospital
      • Kawasakishi, Kanagawa, Japan, 213-0001
        • Ando Orthopaedics Hospital
      • Sagamiharashi, Kanagawa, Japan, 252-5225
        • General Sagami Kosei Hospital
      • Saitama, Kanagawa, Japan, 356-0004
        • Arai Orthopaedic Clinic
      • Yamato-shi, Kanagawa, Japan, 242-0024
        • Saitoh Orthopedic Sports Clinic
    • Saitama
      • Ageo, Saitama, Japan, 362-0021
        • Ageo Medical Clinic
    • Tokyo
      • Adachi, Tokyo, Japan, 120-0033
        • Nakaicho Clinic
      • Chuo, Tokyo, Japan, 104-0031
        • Kyobashi Orthopaedic Clinic
      • Edogawa, Tokyo, Japan, 133-0057
        • Morishima Clinic
      • Katsushika, Tokyo, Japan, 124-0024
        • Shinkoiwa Ekimae Sogo Clinic
      • Meguro, Tokyo, Japan, 152-0002
        • Meguro Seikeigeka Naika
      • Meguro, Tokyo, Japan, 153-0065
        • Meguro Yuai Clinic
      • Ohta, Tokyo, Japan, 145-0066
        • Takemoto Orthopaedic Clinic
      • Shinagawa, Tokyo, Japan, 140-0014
        • Ohimachi Orthopaedic Clinic
      • Shinnzyuku, Tokyo, Japan, 169-0073
        • Shinjuku Research Park Clinic
      • Suginami, Tokyo, Japan, 166-0003
        • Kouenji Orthopedic Clinic
      • Toshima, Tokyo, Japan, 171-0033
        • Daido Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Chronic cervical pain patients with accompanying upper limb radiating pain (neuropathic component) treated with pregabalin or other analgesics

Beskrivelse

Inclusion Criteria:

Subject who received the enough study information and signed informed consent form.

Subject who had chronic pain with accompanying radiating pain to the superior limb beyond the elbow.

Subject is male or female patient ≧20 years old. Subject who reported neck pain with accompanying radiating pain to superior limb (12 weeks or greater in duration at Visit 0).

Subject who is refractory to previous analgesics for 12 weeks and more. Subject who is able and willing to complete all study related assessment tools and complied with scheduled clinic visits and clinical study procedures.

Subject whose pain NRS ≧5 and PRSIS ≧1 at baseline (based on recall over the past week).

Exclusion Criteria:

Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.

Subject who was treated with Pregabalin within the past 12 weeks (on baseline). Subject who has been regularly treated cervical pain with nerve blocks (such as stellate ganglion block, epidural block, radicular block and trigger point injection etc.).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Pregabalin / Other analgesics
Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
Annen: No Intervention
The study is observational.
Other analgesics
Patients will be treated for 8 weeks with other analgesics in usual care: no intervention
Annen: No Intervention
The study is observational.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline at 8 weeks in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
Tidsramme: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). 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, Visit 2 (week 4), Final visit (week 8 or discontinuation)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline in Neck Disability Index (NDI)
Tidsramme: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
The Neck Disability Index (NDI) is an index of how well patients with cervical pain are able to function with regard to daily activities. The score for the index ranges from 0 to 50 with a lower score indicating better function. In the event that a patient has used rescue medication within 12 hours of the clinic visit, the patient should respond to the questions based on their functional ability in the 24 hour period just preceding the use of rescue medication.
Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
Change From Baseline in Pain Numeric Rating Scale (Pain NRS - past week recall)
Tidsramme: Baseline, Visit 2 (week 4), Final visit (week 8 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, Visit 2 (week 4), Final visit (week 8 or discontinuation)
Change From Baseline in Euro Qol- 5 Dimensions -5 Level (EQ-5D-5L)-QOL-Score-
Tidsramme: Baseline, Visit 2 (week 4), Final visit (week 8 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 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.
Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
Change From Baseline in Euro Qol- 5 Dimensions -5 Level (EQ-5D-5L)-Visual Analogue Scale -
Tidsramme: Baseline, Visit 2 (week 4), Final visit (week 8 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, Visit 2 (week 4), Final visit (week 8 or discontinuation)
Clinical Global Impression of Change (CGIC)
Tidsramme: Final visit (week 8 or discontinuation)
The CGIC assessment includes one question (1-7 scale) inquiring about the subject's improvement considering their current disease state.
Final visit (week 8 or discontinuation)
Patient Global Impression of Change (PGIC)
Tidsramme: Final visit (week 8 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 (week 8 or discontinuation)
Work Productivity and Activity Impairment Questionnaire: (WPAI: GH)
Tidsramme: Final visit (week 8 or discontinuation)
The WPAI: GH is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Unlike general health or disease-specific measures, the WPAI:GH assesses function-related endpoints to allow a measure of the economic impact of relative differences in either the safety or efficacy of therapeutic endpoints. In this study, the WPAI: GH will measure the effect of the patient's chronic cervical pain with accompanying upper limb pain (neuropathic component) on work productivity and regular activities.
Final visit (week 8 or discontinuation)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2016

Primær fullføring (Faktiske)

24. oktober 2017

Studiet fullført (Faktiske)

24. oktober 2017

Datoer for studieregistrering

Først innsendt

9. august 2016

Først innsendt som oppfylte QC-kriteriene

11. august 2016

Først lagt ut (Anslag)

16. august 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. januar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. januar 2021

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A0081354

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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