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

NCT02273908 | Completed Results

• 1 other identifier: A0081333
• Study Type: observational
• Target: 331
• Locations: 1 country
• Sites: 33

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.

Conditions

Low-Back Pain

Keywords

Low-Back Pain; Neuropathic Pain; Pregabalin

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)

  The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. 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, Final Visit (Week 8)

Secondary Outcomes (8)

• Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-

  Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)

• Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-

  Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)

• Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)

  Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)

• Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-

  Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)

• Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -

  Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)

Other Outcomes (1)

• Number of Patients With Adverse Events

  Visit2(week4),Final Visit(Week8 or discontinuation)

Study Arms (2)

Pregabalin

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

Other: No intervention

Usual care

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

Other: No intervention

Interventions

No intervention OTHER

The study is observational

Pregabalin; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic low-back pain patients with neuropathic component will be treated with pregabalin or other analgesics

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (33)

Kimura Clinic

Nagoya, Aichi-ken, Japan

Location

Jin Orthopaedic Clinic

Ichikawa, Chiba, 272-0133, Japan

Location

Satoh Orthopaedic Clinic

Ichikawa, Chiba, Japan

Location

Shiraishi Orthopaedic Clinic

Ichikawa, Chiba, Japan

Location

Ota General Hospital

Kawasaki, Kanagawa, Japan

Location

Aoki Orthpaedic Clinic

Sagamihara, Kanagawa, Japan

Location

Hiyoshi Hocho Clinic

Yokohama, Kanagawa, Japan

Location

Yamamoto Memorial Hospital

Yokohama, Kanagawa, Japan

Location

Ageo Medical Clinic

Ageo, Saitama, Japan

Location

Arai Orthopaedic Clinic

Fujimino, Saitama, Japan

Location

Nakaicho Clinic

Adachi City, Tokyo, Japan

Location

Mitsuda Orthopaedic Clinic

Chiyoda City, Tokyo, Japan

Location

Kyobashi Orthopaedic Clinic

Chūō, Tokyo, Japan

Location

Morishima Clinic

Edogawa City, Tokyo, Japan

Location

Kita Akabane Orthopaedic Clinic

Kita-ku, Tokyo, Japan

Location

Takeuchi Orthopaedic Clinic

Kita-ku, Tokyo, Japan

Location

Tanaka Orthopaedic Clinic

Koganei, Tokyo, Japan

Location

Araki Clinic

Koto, Tokyo, Japan

Location

Kohsei Chuo General Hospital

Meguro City, Tokyo, Japan

Location

Meguro Seikeigeka Naika

Meguro City, Tokyo, Japan

Location

Meguro Yuai Clinic

Meguro City, Tokyo, Japan

Location

Takemoto Orthopaedic Clinic

Ohta, Tokyo, Japan

Location

Shiotani Pain Clinic

Shinagawa, Tokyo, Japan

Location

Daido Hospital

Toshima City, Tokyo, Japan

Location

Senkawa Shinoda Orthopaedic Clinic

Toshima City, Tokyo, Japan

Location

Takahashi Orthopaedic Clinic

Toshima City, Tokyo, Japan

Location

Kanazawa Hospital

Kanazawa, Yokohama, Japan

Location

Katayama Orthopaedic Memorial Hospital

Tsurumi, Yokohama, Japan

Location

Nakamura Orthopaedic Clinic

Kagoshima, Japan

Location

Showa-kai Clinic

Kagoshima, Japan

Location

Clinic Ushitani

Miyazaki, Japan

Location

Kohnan Matsumoto Orthopaedic Clinic

Miyazaki, Japan

Location

Iwasaki Orthopaedic Clinic

Saitama, Japan

Location

Related Publications (1)

• 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.

  PMID: 26346468 RESULT

MeSH Terms

Conditions

Low Back Pain; Neuralgia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Study Director : Koichi Fujii, MD
• Organization: Medical Affairs, Pfizer Japan Inc.

koichi.fujii@pfizer.com

81-3-5309-9370

Study Officials

• Koichi Fujii, MD

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 24, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 3, 2021
• Results First Posted: January 6, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (33)