PROs in Chronic Cervical Pain Patients With Accompanying Upper Limb Radiating Pain Treated With Pregabalin
PATIENT-REPORTED-OUTCOMES IN CHRONIC CERVICAL PAIN PATIENTS WITH ACCOMPANYING UPPER LIMB RADIATING PAIN (NEUROPATHIC COMPONENT) TREATED WITH PREGABALIN IN PRIMARY CARE SETTINGS
1 other identifier
observational
369
1 country
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2016
CompletedFirst Posted
Study publicly available on registry
August 16, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 24, 2017
CompletedJanuary 20, 2021
January 1, 2019
1.1 years
August 9, 2016
January 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline at 8 weeks in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
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)
Secondary Outcomes (7)
Change From Baseline in Neck Disability Index (NDI)
Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
Change From Baseline in Pain Numeric Rating Scale (Pain NRS - past week recall)
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-
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 -
Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
Clinical Global Impression of Change (CGIC)
Final visit (week 8 or discontinuation)
- +2 more secondary outcomes
Study Arms (2)
Pregabalin / Other analgesics
Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
Other analgesics
Patients will be treated for 8 weeks with other analgesics in usual care: no intervention
Interventions
Eligibility Criteria
Chronic cervical pain patients with accompanying upper limb radiating pain (neuropathic component) treated with pregabalin or other analgesics
You may qualify if:
- 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).
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Satoh Orthopaedic Clinic
Ichikawa, Chiba, 272-0021, Japan
Shiraishi Orthopaedic Clinic
Ichikawa, Chiba, 272-0138, Japan
Clinic for Sports Medicine and Nutrition
Fukuoka, Fukuoka, 810-0022, Japan
Seiwa Orthopedics Surgery Internal Medicine
Fukuoka, Fukuoka, 812-0041, Japan
Kiheikai Yoh Orthopedic Clinic
Fukuoka, Fukuoka, 812-0046, Japan
Chihaya Hospital
Fukuoka, Fukuoka, 813-8501, Japan
Fukuoka Mirai Hospital
Higashi-ku,Fukuoka, Fukuoka, 813-0017, Japan
Shin Komonji Hospital
Kitakyusyu-shi, Fukuoka, 800-0057, Japan
Fukushima Daiichi Hospital
Fukushima, Fukushima, 960-8251, Japan
Takasaki Pain Clinic
Takasaki-shi, Gunma, 370-0035, Japan
Miyanomori Memorial Hospital
Sapporo, Hokkaido, 064-8570, Japan
Oomuro Orthopedic Clinic
Himeji-shi, Hyōgo, 670-0976, Japan
Oonishi Medical Clinic
Kako-gun, Hyōgo, 675-1115, Japan
Watanabe Orthopaedic Clinic
Kobe, Hyōgo, 657-0824, Japan
Fujisawa Shonandai Hospital
Fujisawa-shi, Kanagawa, 252-0802, Japan
Ando Orthopaedics Hospital
Kawasakishi, Kanagawa, 213-0001, Japan
General Sagami Kosei Hospital
Sagamiharashi, Kanagawa, 252-5225, Japan
Arai Orthopaedic Clinic
Saitama, Kanagawa, 356-0004, Japan
Saitoh Orthopedic Sports Clinic
Yamato-shi, Kanagawa, 242-0024, Japan
Ageo Medical Clinic
Ageo, Saitama, 362-0021, Japan
Nakaicho Clinic
Adachi City, Tokyo, 120-0033, Japan
Kyobashi Orthopaedic Clinic
Chūō, Tokyo, 104-0031, Japan
Morishima Clinic
Edogawa City, Tokyo, 133-0057, Japan
Shinkoiwa Ekimae Sogo Clinic
Katsushika-ku, Tokyo, 124-0024, Japan
Meguro Seikeigeka Naika
Meguro City, Tokyo, 152-0002, Japan
Meguro Yuai Clinic
Meguro City, Tokyo, 153-0065, Japan
Takemoto Orthopaedic Clinic
Ohta, Tokyo, 145-0066, Japan
Ohimachi Orthopaedic Clinic
Shinagawa, Tokyo, 140-0014, Japan
Shinjuku Research Park Clinic
Shinnzyuku, Tokyo, 169-0073, Japan
Kouenji Orthopedic Clinic
Suginami, Tokyo, 166-0003, Japan
Daido Hospital
Toshima City, Tokyo, 171-0033, Japan
Saga-ken Medical Center Koseikan
Saga, 840-8571, Japan
Tokyo Rheumatism Pain Clinic
Tokyo, 104-0031, Japan
Related Publications (1)
Taguchi T, Nozawa K, Parsons B, Yoshiyama T, Ebata N, Igarashi A, Fujii K. Effectiveness of pregabalin for treatment of chronic cervical radiculopathy with upper limb radiating pain: an 8-week, multicenter prospective observational study in Japanese primary care settings. J Pain Res. 2019 May 3;12:1411-1424. doi: 10.2147/JPR.S191906. eCollection 2019.
PMID: 31118759DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2016
First Posted
August 16, 2016
Study Start
October 1, 2016
Primary Completion
October 24, 2017
Study Completion
October 24, 2017
Last Updated
January 20, 2021
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share
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.