Phase 4
Completed N=29
Lumbar Stenosis Outcomes Research (LUSTOR)
Source: ClinicalTrials.gov NCT00638443 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Time to First Symptoms of Moderate Pain — 2.52; 3.06 minutes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of the proposed pilot study is to determine the efficacy of pregabalin in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients with neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing. The secondary objective is to examine the functional benefit of pregabalin with respect to improvement in duration and distance of walking.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Symptoms of Moderate Pain |
2.52; 3.06 | — |
| SECONDARY Final Pain as Measured by NRS |
1.82; 1.53 | — |
| SECONDARY Total Distance |
237.49; 261.55 | — |
| SECONDARY Recovery Time |
2.36; 3.15 | — |
| SECONDARY Area Under the Curve |
100.59; 95.26 | — |
| SECONDARY Visual Analog Scale (VAS) |
52.31; 46.31 | — |
| SECONDARY Oswestry Disability Index (ODI) Score |
37.77; 36.49 | — |
| SECONDARY Swiss Spinal Stenosis (SSS) Score- Symptom Severity |
3.09; 2.94 | — |
| SECONDARY Swiss Spinal Stenosis- Physical Function |
2.40; 2.94 | — |
| SECONDARY Modified Brief Pain Inventory (mBPI)- Interference Score |
3.70; 3.58 | — |
| SECONDARY Roland Morris Disability Questionnaire |
12.98; 11.48 | — |
| SECONDARY Patient Global Assessment (PGA) |
2.75; 2.83 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must present with clinical symptoms of neurogenic claudication (neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing) and endorse limitation of walking tolerance due to these symptoms
- Numeric Rating Scale (NRS) for pain greater than or equal to 6 in response to the following questions: "Circle one number (from 0=no pain to 10=worst pain)-How would you rate the worst leg and lower back pain you experienced during walking last week?"
- Patients must have confirmatory imaging by MRI or CT scan demonstrating at least one level of lumbar spinal stenosis within 1 year
- Duration of symptoms > 3 months
- Age > 50 years; male or female
Exclusion Criteria
- Past or present existence of movement disorder, e.g., Parkinsonism,or a neurologic disease that might affect the ability to ambulate (e.g., signs/symptoms of cauda equina compression)
- Cognitive impairment preventing full understanding or participation in the study
- Peripheral vascular disease
- Moderate to severe arthritis of the knee or hip that might severely compromise ambulation
- Past or present lower extremity peripheral vascular disease
- Serious concomitant medical illness (e.g., heart disease) that might impair ambulation assessment
- Previous lumbar surgery for spinal stenosis (laminectomy with or without fusion) within the past 2 years
- Prior treatment with study drug for neurogenic claudication
- Severe psychiatric disorder
- Mean time to severe symptoms > 15 minutes.
- Epidural steroid treatment within the last three months
- Ongoing treatment with gabapentin
- Hypersensitivity or allergic reaction to diphenhydramine
Data sourced from ClinicalTrials.gov (NCT00638443). 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. Informational only — not medical advice.