Lumbar Stenosis Outcomes Research (LUSTOR) - Full Text View

Sponsors and Collaborators:	University of Rochester Pfizer
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00638443

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 IV

Study Type:	Observational
Study Design:	Cohort, 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:

MedlinePlus related topics: Back Pain Spinal Stenosis

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	37
Study Start Date:	March 2008
Estimated Primary Completion Date:	June 2009 (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

Contacts

Contact: Maria Frazer

585-340-8926

maria_frazer@urmc.rochester.edu

Locations

United States, New York
125 Lattimore Road, Suite 180	Recruiting
Rochester, New York, United States, 14642
Contact: John D Markman 585-276-3616 john_markman@urmc.rochester.edu
Principal Investigator: John D Markman

Sponsors and Collaborators

University of Rochester

Pfizer

Investigators

Principal Investigator:

John D Markman, M.D

University of Rochester

More Information

Publications:

Simon LS, Evans C, Katz N, Bombardier C, West C, Robbins J, Copley-Merriman C, Markman J, Coombs JH. Preliminary development of a responder index for chronic low back pain. J Rheumatol. 2007 Jun;34(6):1386-91.

Markman JD, Dworkin RH. Ion channel targets and treatment efficacy in neuropathic pain. J Pain. 2006 Jan;7(1 Suppl 1):S38-47. Review.

Deen HG Jr, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Test-retest reproducibility of the exercise treadmill examination in lumbar spinal stenosis. Mayo Clin Proc. 2000 Oct;75(10):1002-7.

Deen HG, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Use of the exercise treadmill to measure baseline functional status and surgical outcome in patients with severe lumbar spinal stenosis. Spine. 1998 Jan 15;23(2):244-8.

Stucki G, Daltroy L, Liang MH, Lipson SJ, Fossel AH, Katz JN. Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine. 1996 Apr 1;21(7):796-803.

Responsible Party:	Director, Translational Pain Research ( John D. Markman, M.D. )
Study ID Numbers:	16697, IIR#GA00818X
Study First Received:	March 12, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00638443 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Arterial Occlusive Diseases
Spinal Diseases
Vascular Diseases
Pregabalin
Low Back Pain
Pain
Constriction, Pathologic

Arteriosclerosis
Back Pain
Bone Diseases
Spinal Stenosis
Signs and Symptoms
Musculoskeletal Diseases
Intermittent Claudication

Additional relevant MeSH terms:

Spinal Diseases
Arterial Occlusive Diseases
Pathological Conditions, Anatomical
Signs and Symptoms
Musculoskeletal Diseases
Vascular Diseases

Intermittent Claudication
Cardiovascular Diseases
Constriction, Pathologic
Arteriosclerosis
Bone Diseases
Spinal Stenosis

ClinicalTrials.gov processed this record on September 10, 2009