Clinical trial NCT02273908: PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin
Official title: Patient-reported-outcomes(PROs) in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin in Primary Care Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low-Back Pain
Keywords: Low-Back Pain
Neuropathic Pain
Pregabalin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic low-back pain patients with neuropathic component will be treated with pregabalin or other analgesics

Brief summary: The purpose of this study is to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.

Detailed description: Rational and background :

The care for low back pain associated with neuropathic pain is a problem often encountered in daily outpatient.

And the care effectiveness has been frequently evaluated by the patients directly, because the pain would be felt by patients themselves.

On the view of those, we decided to investigate the clinical treatment outcome of pregabalin or other analgesics medication for relief of pain and improvement of sleep interference and QOLs by Patient-reported outcomes.

Research question and objectives :

To evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic component) treated in primary care settings under routine clinical practice.

Study design:

This is an 8-week, multicenter prospective observational study. Subjects who have chronic low back pain patients with accompanying lower limb pain (with a neuropathic component) and meet all other entry criteria are enrolled at baseline in the duration of study. 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:

1. Subject who received the enough study information and signed informed consent form.
2. Subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle.
3. Subject is male or female patient ≥18 years old.
4. Subject who has complained low back pain for 3 months or more before Visit 1.
5. Subject who is refractory to prior analgesics for 3 months and more.
6. Subject who is able and willing to complete all study related assessment and comply with the study schedule and clinical procedures at clinic.
7. Subject whose pain Numeric Rating Scale(NRS) ≥ 5 at baseline (based on recall over the past week)

Exclusion Criteria:

1. Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.
2. Subject who has been already treated by pregabalin

Primary outcomes:
measure: Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
timeFrame: Baseline, Final Visit (Week 8)
Secondary outcomes:
measure: Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-
timeFrame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
measure: Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-
timeFrame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
measure: Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)
timeFrame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
measure: Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-
timeFrame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
measure: Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -
timeFrame: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
measure: Clinical Global Impression of Change (CGIC)
timeFrame: Final Visit (Week8 or discontinuation)
measure: Patient Global Improvement of Change (PGIC)
timeFrame: Final Visit (Week8 or discontinuation)
measure: Work Productivity and Activity Impairment Scale (WPAI:LBP)
timeFrame: Final Visit (Week8 or discontinuation)
Other outcomes:
measure: Number of Patients With Adverse Events
timeFrame: Visit2(week4),Final Visit(Week8 or discontinuation)
Locations:
city: Nagoya
country: Japan
facility: Kimura Clinic
state: Aichi
city: Ichikawa
country: Japan
facility: Jin Orthopaedic Clinic
state: Chiba
city: Ichikawa
country: Japan
facility: Satoh Orthopaedic Clinic
state: Chiba
city: Ichikawa
country: Japan
facility: Shiraishi Orthopaedic Clinic
state: Chiba
city: Kawasaki
country: Japan
facility: Ota General Hospital
state: Kanagawa
city: Sagamihara
country: Japan
facility: Aoki Orthpaedic Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Hiyoshi Hocho Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Yamamoto Memorial Hospital
state: Kanagawa
city: Ageo
country: Japan
facility: Ageo Medical Clinic
state: Saitama
city: Fujimino
country: Japan
facility: Arai Orthopaedic Clinic
state: Saitama
city: Adachi
country: Japan
facility: Nakaicho Clinic
state: Tokyo
city: Chiyoda
country: Japan
facility: Mitsuda Orthopaedic Clinic
state: Tokyo
city: Chuo
country: Japan
facility: Kyobashi Orthopaedic Clinic
state: Tokyo
city: Edogawa
country: Japan
facility: Morishima Clinic
state: Tokyo
city: Kita
country: Japan
facility: Kita Akabane Orthopaedic Clinic
state: Tokyo
city: Kita
country: Japan
facility: Takeuchi Orthopaedic Clinic
state: Tokyo
city: Koganei
country: Japan
facility: Tanaka Orthopaedic Clinic
state: Tokyo
city: Koto
country: Japan
facility: Araki Clinic
state: Tokyo
city: Meguro
country: Japan
facility: Kohsei Chuo General Hospital
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: Shiotani Pain Clinic
state: Tokyo
city: Toshima
country: Japan
facility: Daido Hospital
state: Tokyo
city: Toshima
country: Japan
facility: Senkawa Shinoda Orthopaedic Clinic
state: Tokyo
city: Toshima
country: Japan
facility: Takahashi Orthopaedic Clinic
state: Tokyo
city: Kanazawa
country: Japan
facility: Kanazawa Hospital
state: Yokohama
city: Tsurumi
country: Japan
facility: Katayama Orthopaedic Memorial Hospital
state: Yokohama
city: Kagoshima
country: Japan
facility: Nakamura Orthopaedic Clinic
city: Kagoshima
country: Japan
facility: Showa-kai Clinic
city: Miyazaki
country: Japan
facility: Clinic Ushitani
city: Miyazaki
country: Japan
facility: Kohnan Matsumoto Orthopaedic Clinic
city: Saitama
country: Japan
facility: Iwasaki Orthopaedic Clinic
Study officials:
affiliation: Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc.
name: Koichi Fujii, MD
role: STUDY_DIRECTOR
References:
citation: Taguchi T, Igarashi A, Watt S, Parsons B, Sadosky A, Nozawa K, Hayakawa K, Yoshiyama T, Ebata N, Fujii K. Effectiveness of pregabalin for the treatment of chronic low back pain with accompanying lower limb pain (neuropathic component): a non-interventional study in Japan. J Pain Res. 2015 Aug 5;8:487-97. doi: 10.2147/JPR.S88642. eCollection 2015.