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Lumbar Stenosis Outcomes Research (LUSTOR)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00638443
First received: March 12, 2008
Last updated: November 9, 2010
Last verified: November 2010
History of Changes
  Purpose

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 intermittent claudication. The secondary objective is to examine the functional benefit of pregabalin with respect to improvement in duration and distance of walking tolerance.

The proposed study will also provide the foundation for a treadmill-based methodology for assessing the analgesic efficacy of drugs for low back pain provoked by standing and walking associated with lumbar spinal stenosis.


Condition Phase
Neurogenic Intermittent Claudication
Lumbar Spinal Stenosis
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lumbar Stenosis Outcomes Research (LUSTOR)- A Randomized, Double-blind, Prospective Placebo Controlled Trial of Pregabalin in Patients With Lumbar Spinal Stenosis and Neuropathic Low Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Time to onset of pain with NRS score greater than or equal to 4, with treadmill ambulation. [ Time Frame: 0-15 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the curve of present pain intensity with ambulation every 30 seconds [ Time Frame: 0-15 minutes ] [ Designated as safety issue: Yes ]
  • Average and worst pain intensity with walking as measured by a 0-10 numerical rating scale [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Walking tolerance as measured by time and distance walked on the treadmill walking test. [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
  • Time to return to baseline pain level after the treadmill ambulation assessment (Trecovery) [ Time Frame: 0+ minutes ] [ Designated as safety issue: No ]
  • Adverse events (sleepiness, light-headedness or dizziness, unsteady gait, slowed thinking or confusion, headache, nausea, and vomiting) graded on a 0-3 scale (0:none, 1:mild, 2:moderate, 3:severe). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Oswestry Disability Index score, Swiss Spinal Stenosis score, Patient Global Impression of Change, and Roland Morris Disability Questionnaire [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
  • Low Back Pain Responder Index [ Time Frame: 0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: March 2008
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Patients must present with clinical symptoms of neurogenic claudication (exercise 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
  • Leg/low back pain ratio must be greater than 50:50
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638443

Locations
United States, New York
2180 South Clinton Avenue
Rochester, New York, United States, 14618
Sponsors and Collaborators
University of Rochester
Pfizer
Investigators
Principal Investigator: John D Markman, M.D University of Rochester
  More Information

Publications:

Responsible Party: John D. Markman, M.D., Director, Translational Pain Research
ClinicalTrials.gov Identifier: NCT00638443     History of Changes
Other Study ID Numbers: 16697, IIR#GA00818X
Study First Received: March 12, 2008
Last Updated: November 9, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Constriction, Pathologic
Intermittent Claudication
Spinal Stenosis
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013