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

2021년 1월 15일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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).

연구 유형

관찰

등록 (실제)

369

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Pregabalin / Other analgesics
Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
다른: No Intervention
The study is observational.
Other analgesics
Patients will be treated for 8 weeks with other analgesics in usual care: no intervention
다른: No Intervention
The study is observational.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline at 8 weeks in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Neck Disability Index (NDI)
기간: 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)
기간: 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-
기간: 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 -
기간: 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)
기간: 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)
기간: 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)
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 10월 1일

기본 완료 (실제)

2017년 10월 24일

연구 완료 (실제)

2017년 10월 24일

연구 등록 날짜

최초 제출

2016년 8월 9일

QC 기준을 충족하는 최초 제출

2016년 8월 11일

처음 게시됨 (추정)

2016년 8월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 1월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 1월 15일

마지막으로 확인됨

2019년 1월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A0081354

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

경추 통증에 대한 임상 시험

No Intervention에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Mongolia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다