PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin

NCT ID: NCT02273908

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 331 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-03-31

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).

Conditions

Low-Back Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregabalin

Patients will be treated for 8 weeks with pregabalin in primary care: no intervention

No intervention

Intervention Type: OTHER

The study is observational

Usual care

Patients will be treated for 8 weeks with other analgesics in usual care: no intervention

No intervention

Intervention Type: OTHER

The study is observational

Interventions

No intervention

The study is observational

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Koichi Fujii, MD

Role: STUDY_DIRECTOR

Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc.

Locations

Kimura Clinic

Nagoya, Aichi-ken, Japan

Jin Orthopaedic Clinic

Ichikawa, Chiba, Japan

Satoh Orthopaedic Clinic

Ichikawa, Chiba, Japan

Shiraishi Orthopaedic Clinic

Ichikawa, Chiba, Japan

Ota General Hospital

Kawasaki, Kanagawa, Japan

Aoki Orthpaedic Clinic

Sagamihara, Kanagawa, Japan

Hiyoshi Hocho Clinic

Yokohama, Kanagawa, Japan

Yamamoto Memorial Hospital

Yokohama, Kanagawa, Japan

Ageo Medical Clinic

Ageo, Saitama, Japan

Arai Orthopaedic Clinic

Fujimino, Saitama, Japan

Nakaicho Clinic

Adachi City, Tokyo, Japan

Mitsuda Orthopaedic Clinic

Chiyoda City, Tokyo, Japan

Kyobashi Orthopaedic Clinic

Chūō, Tokyo, Japan

Morishima Clinic

Edogawa City, Tokyo, Japan

Kita Akabane Orthopaedic Clinic

Kita-ku, Tokyo, Japan

Takeuchi Orthopaedic Clinic

Kita-ku, Tokyo, Japan

Tanaka Orthopaedic Clinic

Koganei, Tokyo, Japan

Araki Clinic

Koto, Tokyo, Japan

Kohsei Chuo General Hospital

Meguro City, Tokyo, Japan

Meguro Seikeigeka Naika

Meguro City, Tokyo, Japan

Meguro Yuai Clinic

Meguro City, Tokyo, Japan

Takemoto Orthopaedic Clinic

Ohta, Tokyo, Japan

Shiotani Pain Clinic

Shinagawa, Tokyo, Japan

Daido Hospital

Toshima City, Tokyo, Japan

Senkawa Shinoda Orthopaedic Clinic

Toshima City, Tokyo, Japan

Takahashi Orthopaedic Clinic

Toshima City, Tokyo, Japan

Kanazawa Hospital

Kanazawa, Yokohama, Japan

Katayama Orthopaedic Memorial Hospital

Tsurumi, Yokohama, Japan

Nakamura Orthopaedic Clinic

Kagoshima, , Japan

Showa-kai Clinic

Kagoshima, , Japan

Clinic Ushitani

Miyazaki, , Japan

Kohnan Matsumoto Orthopaedic Clinic

Miyazaki, , Japan

Iwasaki Orthopaedic Clinic

Saitama, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 26346468 (View on PubMed)

Other Identifiers

A0081333

Identifier Type: -

Identifier Source: org_study_id