You are here

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

Last updated on April 10, 2018

FOR MORE INFORMATION
Study Location
Kimura Clinic
Nagoya, Aichi, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low-Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT02273908
Pfizer
Completed
PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Low Back Pain
NCT02528253
All Genders
18+
Years
Multiple Sites
Chronic Pain, Hip Osteoarthritis, Knee Osteoarthritis
NCT02528188
All Genders
18+
Years
Multiple Sites
Moderate-severe Pain
NCT02101554
All Genders
7+
Years
Multiple Sites
PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin
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.

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).

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Chronic low-back pain patients with neuropathic component will be treated with pregabalin or other analgesics
Low-Back Pain
Other: No intervention
The study is observational
  • Pregabalin
    Patients will be treated for 8 weeks with pregabalin in primary care: no intervention
    Intervention: Other: No intervention
  • Usual care
    Patients will be treated for 8 weeks with other analgesics in usual care: no intervention
    Intervention: Other: No intervention
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
331
March 2015
February 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT02273908
A0081333
No
Not Provided
Plan to Share IPD: No
Pfizer
Pfizer
Not Provided
Study Director: Koichi Fujii, MD Director of Pain/Neuroscience Medical Affairs,Pfizer Japan Inc.
Pfizer
October 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now