N/A
N=331
PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin
Low-Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT02273908 ↗Enrolled (actual)
331
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) — 3.1; 2.9; -1.306; -0.357 scores on a scale — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall) |
3.1; 2.9; -1.306; -0.357 | <0.001 sig |
| SECONDARY Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score- |
10.8; 9.1; -2.893; -1.006; -3.670; -1.411 | <0.001 sig |
| SECONDARY Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score- |
39.77; 44.92; 5.1062; 2.3772; 6.8377; 3.5359 | <0.001 sig |
| SECONDARY Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall) |
6.2; 5.8; 1.763; -1.089; -2.166; -1.336 | <0.001 sig |
| SECONDARY Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score- |
0.6647; 0.7233; 0.0756; 0.0427; 0.0804; 0.0600 | 0.175 |
| SECONDARY Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale - |
60.9; 63.0; 2.633; 1.341; 6.970; 2.272 | 0.026 sig |
| SECONDARY Clinical Global Impression of Change (CGIC) |
17; 3; 47; 24; 37; 47 | <0.001 sig |
| SECONDARY Patient Global Improvement of Change (PGIC) |
8; 5; 34; 22; 45; 44 | <0.001 sig |
| SECONDARY Work Productivity and Activity Impairment Scale (WPAI:LBP) |
0.13; 1.61; 28.84; 27.09; 28.88; 27.84 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02273908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.