Clinical trial NCT02868359: PROs in Chronic Cervical Pain Patients With Accompanying Upper Limb Radiating Pain Treated With Pregabalin
Official title: PATIENT-REPORTED-OUTCOMES IN CHRONIC CERVICAL PAIN PATIENTS WITH ACCOMPANYING UPPER LIMB RADIATING PAIN (NEUROPATHIC COMPONENT) TREATED WITH PREGABALIN IN PRIMARY CARE SETTINGS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Pain
Neuropathic Pain
Radiating Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 369
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic cervical pain patients with accompanying upper limb radiating pain (neuropathic component) treated with pregabalin or other analgesics

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.

Detailed description: 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).

Eligibility criteria: 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.).

Primary outcomes:
measure: Change From Baseline at 8 weeks in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
timeFrame: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
Secondary outcomes:
measure: Change From Baseline in Neck Disability Index (NDI)
timeFrame: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
measure: Change From Baseline in Pain Numeric Rating Scale (Pain NRS - past week recall)
timeFrame: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
measure: Change From Baseline in Euro Qol- 5 Dimensions -5 Level (EQ-5D-5L)-QOL-Score-
timeFrame: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
measure: Change From Baseline in Euro Qol- 5 Dimensions -5 Level (EQ-5D-5L)-Visual Analogue Scale -
timeFrame: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
measure: Clinical Global Impression of Change (CGIC)
timeFrame: Final visit (week 8 or discontinuation)
measure: Patient Global Impression of Change (PGIC)
timeFrame: Final visit (week 8 or discontinuation)
measure: Work Productivity and Activity Impairment Questionnaire: (WPAI: GH)
timeFrame: Final visit (week 8 or discontinuation)
Other outcomes:
Locations:
city: Ichikawa
country: Japan
facility: Satoh Orthopaedic Clinic
state: Chiba
city: Ichikawa
country: Japan
facility: Shiraishi Orthopaedic Clinic
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Chihaya Hospital
state: Fukuoka
city: Fukuokashi
country: Japan
facility: Clinic for Sports Medicine and Nutrition
state: Fukuoka
city: Fukuokashi
country: Japan
facility: Seiwa Orthopedics Surgery Internal Medicine
state: Fukuoka
city: Fukuokashi
country: Japan
facility: Kiheikai Yoh Orthopedic Clinic
state: Fukuoka
city: Higashi-ku,Fukuoka
country: Japan
facility: Fukuoka Mirai Hospital
state: Fukuoka
city: Kitakyusyu-shi
country: Japan
facility: Shin Komonji Hospital
state: Fukuoka
city: Takasaki-shi
country: Japan
facility: Takasaki Pain Clinic
state: Gunma
city: Sapporoshi
country: Japan
facility: Miyanomori Memorial Hospital
state: Hokkaido
city: Himeji-shi
country: Japan
facility: Oomuro Orthopedic Clinic
state: Hyogo
city: Kako-gun
country: Japan
facility: Oonishi Medical Clinic
state: Hyogo
city: Kobe
country: Japan
facility: Watanabe Orthopaedic Clinic
state: Hyogo
city: Fujisawa-shi
country: Japan
facility: Fujisawa Shonandai Hospital
state: Kanagawa
city: Kawasakishi
country: Japan
facility: Ando Orthopaedics Hospital
state: Kanagawa
city: Sagamiharashi
country: Japan
facility: General Sagami Kosei Hospital
state: Kanagawa
city: Saitama
country: Japan
facility: Arai Orthopaedic Clinic
state: Kanagawa
city: Yamato-shi
country: Japan
facility: Saitoh Orthopedic Sports Clinic
state: Kanagawa
city: Ageo
country: Japan
facility: Ageo Medical Clinic
state: Saitama
city: Adachi
country: Japan
facility: Nakaicho Clinic
state: Tokyo
city: Chuo
country: Japan
facility: Kyobashi Orthopaedic Clinic
state: Tokyo
city: Edogawa
country: Japan
facility: Morishima Clinic
state: Tokyo
city: Katsushika
country: Japan
facility: Shinkoiwa Ekimae Sogo Clinic
state: Tokyo
city: Meguro
country: Japan
facility: Meguro Seikeigeka Naika
state: Tokyo
city: Meguro
country: Japan
facility: Meguro Yuai Clinic
state: Tokyo
city: Ohta
country: Japan
facility: Takemoto Orthopaedic Clinic
state: Tokyo
city: Shinagawa
country: Japan
facility: Ohimachi Orthopaedic Clinic
state: Tokyo
city: Shinnzyuku
country: Japan
facility: Shinjuku Research Park Clinic
state: Tokyo
city: Suginami
country: Japan
facility: Kouenji Orthopedic Clinic
state: Tokyo
city: Toshima
country: Japan
facility: Daido Hospital
state: Tokyo
city: Fukusima
country: Japan
facility: Fukushima Daiichi Hospital
city: Saga
country: Japan
facility: Saga-ken Medical Center Koseikan
city: Tokyo
country: Japan
facility: Tokyo Rheumatism Pain Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.