Lumbar Stenosis Outcomes Research (LUSTOR)

NCT00638443 | Completed Phase 4 Results DMC

• 2 other identifiers: 16697IIR#GA00818X
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Spinal Stenosis

Keywords

Neurogenic claudication, lumbar spinal stenosis, treadmill testing

Outcome Measures

Primary Outcomes (1)

• Time to First Symptoms of Moderate Pain

  Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured.

  10 days

Secondary Outcomes (11)

• Final Pain as Measured by NRS

  10 days

• Total Distance

  10 days

• Recovery Time

  10 days

• Area Under the Curve

  10 days

• Visual Analog Scale (VAS)

  10 days

Study Arms (2)

Pregabalin then Diphenhydramine

OTHER

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; no drug for 7 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.

Drug: Pregabalin; Drug: Diphenhydramine

Diphenhydramine then Pregabalin

OTHER

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; no drug for 7 days; 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.

Drug: Pregabalin; Drug: Diphenhydramine

Interventions

Pregabalin DRUG

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.

Also known as: Lyrica

Diphenhydramine then Pregabalin; Pregabalin then Diphenhydramine

Diphenhydramine DRUG

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.

Also known as: Benedryl

Diphenhydramine then Pregabalin; Pregabalin then Diphenhydramine

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Pfizer: collaborator

Study Sites (1)

2180 South Clinton Avenue

Rochester, New York, 14618, United States

Location

Related Publications (5)

• 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.

  PMID: 17552065 BACKGROUND

• Markman JD, Dworkin RH. Ion channel targets and treatment efficacy in neuropathic pain. J Pain. 2006 Jan;7(1 Suppl 1):S38-47. doi: 10.1016/j.jpain.2005.09.008.

  PMID: 16427000 BACKGROUND

• 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. doi: 10.4065/75.10.1002.

  PMID: 11040847 BACKGROUND

• 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. doi: 10.1097/00007632-199801150-00019.

  PMID: 9474733 BACKGROUND

• 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. doi: 10.1097/00007632-199604010-00004.

  PMID: 8779009 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Pregabalin; Diphenhydramine

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: John Markman, MD
• Organization: University of Rochester

maria_frazer@urmc.rochester.edu

585-340-8926

Study Officials

• John D Markman, M.D

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Translational Pain Research

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 20, 2016
• Results First Posted: June 20, 2016

Record last verified: 2016-05

Locations

US (1)