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

Viatris

Status: Completed

Conditions: Low-Back Pain

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02273908

A0081333

Details and patient eligibility

About

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.

Full 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).

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

331 participants in 2 patient groups

Pregabalin

Description:

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

Treatment:

Other: No intervention

Usual care

Description:

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

Treatment:

Other: No intervention