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

Study Overview
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Brief Summary
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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
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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).

Official Title
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PATIENT-REPORTED-OUTCOMES IN CHRONIC CERVICAL PAIN PATIENTS WITH ACCOMPANYING UPPER LIMB RADIATING PAIN (NEUROPATHIC COMPONENT) TREATED WITH PREGABALIN IN PRIMARY CARE SETTINGS

Conditions
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Cervical Pain, Neuropathic Pain, Radiating Pain

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregabalin / Other analgesics<br>Patients will be treated for 8 weeks with pregabalin in primary care: no intervention | Other: No Intervention<br>* The study is observational.<br>|
| Other analgesics<br>Patients will be treated for 8 weeks with other analgesics in usual care: no intervention | Other: No Intervention<br>* The study is observational.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Neck Disability Index (NDI) | 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) | 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- | 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 - | 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) | 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) | 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) | 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) |