Lumbar Stenosis Outcomes Research (LUSTOR)

Lumbar Spinal Stenosis Clinical Trial

— LUSTOR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638443
• Other study ID #: 16697
• Secondary ID: IIR#GA00818X
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2008
• Last updated: November 9, 2010
• Start date: March 2008
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intermittent Claudication
• Lumbar Spinal Stenosis
• Neurogenic Intermittent Claudication
• Spinal Stenosis

Locations

Country	Name	City	State
United States	2180 South Clinton Avenue	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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 (Phila Pa 1976). 1998 Jan 15;23(2):244-8. — View Citation

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

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. — View Citation

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 (Phila Pa 1976). 1996 Apr 1;21(7):796-803. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to onset of pain with NRS score greater than or equal to 4, with treadmill ambulation.		0-15 minutes	Yes
Secondary	Area under the curve of present pain intensity with ambulation every 30 seconds		0-15 minutes	Yes
Secondary	Average and worst pain intensity with walking as measured by a 0-10 numerical rating scale		30 days	No
Secondary	Walking tolerance as measured by time and distance walked on the treadmill walking test.		15 minutes	Yes
Secondary	Time to return to baseline pain level after the treadmill ambulation assessment (Trecovery)		0+ minutes	No
Secondary	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).		6 months	Yes
Secondary	Oswestry Disability Index score, Swiss Spinal Stenosis score, Patient Global Impression of Change, and Roland Morris Disability Questionnaire		15 minutes	No
Secondary	Low Back Pain Responder Index		0	No