Lumbar Stenosis Outcomes Research (LUSTOR)
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Intervention: Pregabalin; Diphenhydramine
Intervention description: Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.; diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
Intervention MeSH terms: Diphenhydramine; Promethazine; Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Neurogenic claudication, lumbar spinal stenosis, treadmill testing

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