Cervical PainNCT02868359
PROs in Chronic Cervical Pain Patients With Accompanying Upper Limb Radiating Pain Treated With Pregabalin
An observational study of Cervical Pain and Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cervical Pain, Neuropathic Pain, Radiating Pain
- How many people
- 369 participants
- Where
- 33 sitesJapan
- Study dates
- Oct 2016to 24 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic cervical pain patients with accompanying upper limb radiating pain (neuropathic component) treated with pregabalin or other analgesics
Who may be able to join
- 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).
Who cannot join
- 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.).
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
Japan33 sites
Nakaicho Clinic
Adachi City, Tokyo, 120-0033
Ageo Medical Clinic
Ageo, Saitama, 362-0021
Kyobashi Orthopaedic Clinic
Chūō, Tokyo, 104-0031
Morishima Clinic
Edogawa City, Tokyo, 133-0057
Fujisawa Shonandai Hospital
Fujisawa-shi, Kanagawa, 252-0802
Clinic for Sports Medicine and Nutrition
Fukuoka, Fukuoka, 810-0022
Seiwa Orthopedics Surgery Internal Medicine
Fukuoka, Fukuoka, 812-0041
Kiheikai Yoh Orthopedic Clinic
Fukuoka, Fukuoka, 812-0046
Chihaya Hospital
Fukuoka, Fukuoka, 813-8501
Fukushima Daiichi Hospital
Fukushima, Fukushima, 960-8251
Fukuoka Mirai Hospital
Higashi-ku,Fukuoka, Fukuoka, 813-0017
Oomuro Orthopedic Clinic
Himeji-shi, Hyōgo, 670-0976
Satoh Orthopaedic Clinic
Ichikawa, Chiba, 272-0021
Shiraishi Orthopaedic Clinic
Ichikawa, Chiba, 272-0138
Oonishi Medical Clinic
Kako-gun, Hyōgo, 675-1115
Shinkoiwa Ekimae Sogo Clinic
Katsushika-ku, Tokyo, 124-0024
Ando Orthopaedics Hospital
Kawasakishi, Kanagawa, 213-0001
Shin Komonji Hospital
Kitakyusyu-shi, Fukuoka, 800-0057
Watanabe Orthopaedic Clinic
Kobe, Hyōgo, 657-0824
Meguro Seikeigeka Naika
Meguro City, Tokyo, 152-0002
Meguro Yuai Clinic
Meguro City, Tokyo, 153-0065
Takemoto Orthopaedic Clinic
Ohta, Tokyo, 145-0066
Saga-ken Medical Center Koseikan
Saga, 840-8571
General Sagami Kosei Hospital
Sagamiharashi, Kanagawa, 252-5225
Arai Orthopaedic Clinic
Saitama, Kanagawa, 356-0004
Miyanomori Memorial Hospital
Sapporo, Hokkaido, 064-8570
Ohimachi Orthopaedic Clinic
Shinagawa, Tokyo, 140-0014
Shinjuku Research Park Clinic
Shinnzyuku, Tokyo, 169-0073
Kouenji Orthopedic Clinic
Suginami, Tokyo, 166-0003
Takasaki Pain Clinic
Takasaki-shi, Gunma, 370-0035
Tokyo Rheumatism Pain Clinic
Tokyo, 104-0031
Daido Hospital
Toshima City, Tokyo, 171-0033
Saitoh Orthopedic Sports Clinic
Yamato-shi, Kanagawa, 242-0024
About this study
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
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.
Read the 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).
- Conditions
- Cervical Pain, Neuropathic Pain, Radiating Pain
- Being tested
- No Intervention
- Medical subject headings
- Neck Pain, Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
The study is observational.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin / Other analgesics | Patients will be treated for 8 weeks with pregabalin in primary care: no intervention Receives: Other: No Intervention | |
| Other analgesics | Patients will be treated for 8 weeks with other analgesics in usual care: no intervention Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Final visit (week 8 or discontinuation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startOct 2016
- Primary completion24 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868359
- Sponsor's protocol ID
- A0081354
- Status last verified
- Jan 2019
- First submitted
- 9 Aug 2016
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31118759
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02868359
- Acronym / sponsor ID
- A0081354
- Conditions
- Cervical Pain, Neuropathic Pain, Radiating Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 16 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin / Other analgesics | – | Other: No InterventionPatients will be treated for 8 weeks with pregabalin in primary care: no intervention |
| Other analgesics | – | Other: No InterventionPatients will be treated for 8 weeks with other analgesics in usual care: no intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic cervical pain patients with accompanying upper limb radiating pain (neuropathic component) treated with pregabalin or other analgesics
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThe study is observational. | Other | Other analgesics, Pregabalin / Other analgesics |
Primary outcome
Change From Baseline at 8 weeks in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
Time frame: 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.
7 secondary outcomes
Change From Baseline in Neck Disability Index (NDI)
Time frame: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
Change From Baseline in Pain Numeric Rating Scale (Pain NRS - past week recall)
Time frame: 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-
Time frame: 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 -
Time frame: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)
Clinical Global Impression of Change (CGIC)
Time frame: Final visit (week 8 or discontinuation)
Patient Global Impression of Change (PGIC)
Time frame: Final visit (week 8 or discontinuation)
Work Productivity and Activity Impairment Questionnaire: (WPAI: GH)
Time frame: Final visit (week 8 or discontinuation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 31118759Taguchi 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Pain and Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 33 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at 8 weeks in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) (time frame: Baseline, Visit 2 (week 4), Final visit (week 8 or discontinuation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02868359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.