Phase 4 N=29 Randomized Triple-blind Treatment

Lumbar Stenosis Outcomes Research (LUSTOR)

Lumbar Spinal Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT00638443 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2016

Primary outcome: Primary: Time to First Symptoms of Moderate Pain — 2.52; 3.06 minutes

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pregabalin (Drug); Diphenhydramine (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Mar 2010

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	—

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.

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

View full record on ClinicalTrials.gov →

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.