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

2021年1月15日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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).

研究の種類

観察的

入学 (実際)

369

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Pregabalin / Other analgesics
Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
他の：No Intervention
The study is observational.
Other analgesics
Patients will be treated for 8 weeks with other analgesics in usual care: no intervention
他の：No Intervention
The study is observational.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline at 8 weeks in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Neck Disability Index (NDI)
時間枠：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)
時間枠：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-
時間枠：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 -
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

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

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2016年10月1日

一次修了 (実際)

2017年10月24日

研究の完了 (実際)

2017年10月24日

試験登録日

最初に提出

2016年8月9日

QC基準を満たした最初の提出物

2016年8月11日

最初の投稿 (見積もり)

2016年8月16日

学習記録の更新

投稿された最後の更新 (実際)

2021年1月20日

QC基準を満たした最後の更新が送信されました

2021年1月15日

最終確認日

2019年1月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • A0081354

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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