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

Patient-reported-outcomes(PROs) in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin in Primary Care Settings

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.

Study Overview

• Status: Completed
• Conditions: Low-Back Pain
• Intervention / Treatment: Other: No intervention

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).

• Study Type: Observational
• Enrollment (Actual): 331

Contacts and Locations

Study Locations

• Japan
  • Kagoshima, Japan
    • Nakamura Orthopaedic Clinic
  • Kagoshima, Japan
    • Showa-kai Clinic
  • Miyazaki, Japan
    • Clinic Ushitani
  • Miyazaki, Japan
    • Kohnan Matsumoto Orthopaedic Clinic
  • Saitama, Japan
    • Iwasaki Orthopaedic Clinic
  • Aichi
    • Nagoya, Aichi, Japan
      • Kimura Clinic
  • Chiba
    • Ichikawa, Chiba, Japan, 272-0133
      • Jin Orthopaedic Clinic
    • Ichikawa, Chiba, Japan
      • Satoh Orthopaedic Clinic
    • Ichikawa, Chiba, Japan
      • Shiraishi Orthopaedic Clinic
  • Kanagawa
    • Kawasaki, Kanagawa, Japan
      • Ota General Hospital
    • Sagamihara, Kanagawa, Japan
      • Aoki Orthpaedic Clinic
    • Yokohama, Kanagawa, Japan
      • Hiyoshi Hocho Clinic
    • Yokohama, Kanagawa, Japan
      • Yamamoto Memorial Hospital
  • Saitama
    • Ageo, Saitama, Japan
      • Ageo Medical Clinic
    • Fujimino, Saitama, Japan
      • Arai Orthopaedic Clinic
  • Tokyo
    • Adachi, Tokyo, Japan
      • Nakaicho Clinic
    • Chiyoda, Tokyo, Japan
      • Mitsuda Orthopaedic Clinic
    • Chuo, Tokyo, Japan
      • Kyobashi Orthopaedic Clinic
    • Edogawa, Tokyo, Japan
      • Morishima Clinic
    • Kita, Tokyo, Japan
      • Kita Akabane Orthopaedic Clinic
    • Kita, Tokyo, Japan
      • Takeuchi Orthopaedic Clinic
    • Koganei, Tokyo, Japan
      • Tanaka Orthopaedic Clinic
    • Koto, Tokyo, Japan
      • Araki Clinic
    • Meguro, Tokyo, Japan
      • Kohsei Chuo General Hospital
    • Meguro, Tokyo, Japan
      • Meguro Seikeigeka Naika
    • Meguro, Tokyo, Japan
      • Meguro Yuai Clinic
    • Ohta, Tokyo, Japan
      • Takemoto Orthopaedic Clinic
    • Shinagawa, Tokyo, Japan
      • Shiotani Pain Clinic
    • Toshima, Tokyo, Japan
      • Daido Hospital
    • Toshima, Tokyo, Japan
      • Senkawa Shinoda Orthopaedic Clinic
    • Toshima, Tokyo, Japan
      • Takahashi Orthopaedic Clinic
  • Yokohama
    • Kanazawa, Yokohama, Japan
      • Kanazawa Hospital
    • Tsurumi, Yokohama, Japan
      • Katayama Orthopaedic Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregabalin; Patients will be treated for 8 weeks with pregabalin in primary care: no intervention	Other: No intervention; The study is observational
Usual care; Patients will be treated for 8 weeks with other analgesics in usual care: no intervention	Other: No intervention; The study is observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-	The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.	Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-	The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.	Baseline, Visit2 (Week4), Final Visit (Week8 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, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Euro Qol 5-Dimensions (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. 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.; 1 indicates better health state (no problems); 5 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile; from 11111 to 55555. Score is transformed and results in a total score range -0.025 to 1.000; higher score indicates a better health state.	Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)
Change From Baseline in Euro Qol 5-Dimensions (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, Visit2 (Week4), Final Visit (Week8 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.; range from 1 (very much improved) to 7 (very much worse).	Final Visit (Week8 or discontinuation)
Patient Global Improvement 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 (Week8 or discontinuation)
Work Productivity and Activity Impairment Scale (WPAI:LBP)	The WPAI: LBP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, "n" signifies "Number of participants" for Baseline. In this study, the WPAI: LBP will measure the effect of the patient's Chronic Low Back Pain (CLBP) with accompanying lower limb pain (neuropathic component) on work productivity and regular activities.	Final Visit (Week8 or discontinuation)

Other Outcome Measures

Outcome Measure	Time Frame
Number of Patients With Adverse Events	Visit2(week4),Final Visit(Week8 or discontinuation)

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Investigators: Study Director: Koichi Fujii, MD, Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Pregabalin; Neuropathic Pain; Low-Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: A0081333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No