PROs in Chronic Cervical Pain Patients With Accompanying Upper Limb Radiating Pain Treated With Pregabalin
NCT ID: NCT02868359
Last Updated: 2021-01-20
Study Results
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Basic Information
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COMPLETED
369 participants
OBSERVATIONAL
2016-10-31
2017-10-24
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pregabalin / Other analgesics
Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
No Intervention
The study is observational.
Other analgesics
Patients will be treated for 8 weeks with other analgesics in usual care: no intervention
No Intervention
The study is observational.
Interventions
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No Intervention
The study is observational.
Eligibility Criteria
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Inclusion Criteria
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 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.).
20 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Satoh Orthopaedic Clinic
Ichikawa, Chiba, Japan
Shiraishi Orthopaedic Clinic
Ichikawa, Chiba, Japan
Clinic for Sports Medicine and Nutrition
Fukuoka, Fukuoka, Japan
Seiwa Orthopedics Surgery Internal Medicine
Fukuoka, Fukuoka, Japan
Kiheikai Yoh Orthopedic Clinic
Fukuoka, Fukuoka, Japan
Chihaya Hospital
Fukuoka, Fukuoka, Japan
Fukuoka Mirai Hospital
Higashi-ku,Fukuoka, Fukuoka, Japan
Shin Komonji Hospital
Kitakyusyu-shi, Fukuoka, Japan
Fukushima Daiichi Hospital
Fukushima, Fukushima, Japan
Takasaki Pain Clinic
Takasaki-shi, Gunma, Japan
Miyanomori Memorial Hospital
Sapporo, Hokkaido, Japan
Oomuro Orthopedic Clinic
Himeji-shi, Hyōgo, Japan
Oonishi Medical Clinic
Kako-gun, Hyōgo, Japan
Watanabe Orthopaedic Clinic
Kobe, Hyōgo, Japan
Fujisawa Shonandai Hospital
Fujisawa-shi, Kanagawa, Japan
Ando Orthopaedics Hospital
Kawasakishi, Kanagawa, Japan
General Sagami Kosei Hospital
Sagamiharashi, Kanagawa, Japan
Arai Orthopaedic Clinic
Saitama, Kanagawa, Japan
Saitoh Orthopedic Sports Clinic
Yamato-shi, Kanagawa, Japan
Ageo Medical Clinic
Ageo, Saitama, Japan
Nakaicho Clinic
Adachi City, Tokyo, Japan
Kyobashi Orthopaedic Clinic
Chūō, Tokyo, Japan
Morishima Clinic
Edogawa City, Tokyo, Japan
Shinkoiwa Ekimae Sogo Clinic
Katsushika-ku, Tokyo, Japan
Meguro Seikeigeka Naika
Meguro City, Tokyo, Japan
Meguro Yuai Clinic
Meguro City, Tokyo, Japan
Takemoto Orthopaedic Clinic
Ohta, Tokyo, Japan
Ohimachi Orthopaedic Clinic
Shinagawa, Tokyo, Japan
Shinjuku Research Park Clinic
Shinnzyuku, Tokyo, Japan
Kouenji Orthopedic Clinic
Suginami, Tokyo, Japan
Daido Hospital
Toshima City, Tokyo, Japan
Saga-ken Medical Center Koseikan
Saga, , Japan
Tokyo Rheumatism Pain Clinic
Tokyo, , Japan
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081354
Identifier Type: -
Identifier Source: org_study_id
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