Low back pain low back pain
Conditions
Interventions
The investigator will administer pregabalin in a flexible dose-escalation
regimen titrated in accordance with individual response and tolerability as
determined by the investigator. Pregabalin will
Sponsors
Pfizer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients (aged 18 years or over) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 2. Patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study. 3. Patients must have a score of at least 19 on the PainDetect questionnaire and at least 4 on the Standardized Evaluation of Pain (StEP) scale at baseline. 4. Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period (based on patients having completed at least 4 daily pain diaries within the last 7 days). 5. Patients must be taking stable pain medication (for 30 days). 6. Patients must have failed to respond to standard analgesic therapy (eg, non-steroidal anti-inflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (eg, tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering the study). 7. Female subjects of childbearing potential must not be pregnant or lactating at screening and must have a negative urine pregnancy test at screening (women post-menopausal for
Exclusion criteria
Exclusion criteria: 1. Participation in other studies within 30 days before the current study begins and/or during study participation. 2. Other severe acute or chronic medical condition (eg, cancer) or psychiatric condition (including suicidal behaviour or active suicidal ideation) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 3. A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of > 15 on the depression sub-scale only. 4. Patients with a history of renal impairment or who have reduced renal function at baseline (Creatinine Clearance 60 mg per day). 8. Patients with a contraindication to receiving pregabalin as per the EU Summary of Product Characteristics (SmPC). 9. Pregnant or lactating women, or women of childbearing potential including women less than two years post-menopausal not using an effective method of contraception. 10. Patients scheduled to have planned or elective surgery during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 12) compared with baseline. 2. The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The time to onset of 30% pain reduction (as measured by the NRS mean pain score). 2. The change in the Hospital Anxiety and Depression Scale (HADS) score at the end of the study (Week 12) compared with baseline. 3. The change in the Sleep Interference Scale score at the end of the study (Week 12) compared with baseline. 4. The change in the Lost Work Day Equivalent (LWDE) score at the end of the study (Week 12) compared with baseline. 5. The change in the Roland-Morris Disability Questionnaire (RMDQ) score at the end of the study (Week 12) compared with baseline. 6. The change in the PainDetect score from baseline versus the change in the Standardized Evaluation of Pain (StEP) score from baseline at the end of the study (Week 12). 7. The proportion of patients with a 30% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score). 8. The proportion of patients with a 50% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score). 9. The percentage of primary care physicians who find screening tools useful instruments to support the identification of patients with neuropathic chronic low back pain in daily practice. 10. The nature and incidence of adverse events for patients taking 150 mg pregabalin at night as a single dose, either for one week prior to dose escalation or as continued after the option to escalate dose following one week in the study. | — |
Countries
Netherlands
Outcome results
None listed