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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01943435 |
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Date of registration:
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08/09/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
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Scientific title:
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A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis |
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Date of first enrolment:
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November 20, 2013 |
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Target sample size:
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259 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01943435 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael J Schneider, PhD, DC |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Minimum age of 60 years
- Can read/write English and understand directions
- Diagnosis of lumbar spinal stenosis confirmed by CT or MRI scan
- Has limitation of standing and/or walking tolerance
- Willing to attend treatments 2 times per week for 6 weeks
- Ability to walk at least 50 feet without the need for a cane or walker
Exclusion Criteria:
- History of metastatic cancer
- Advised by a physician not to exercise
- History of lumbar surgery for spinal stenosis or previous lumbar fusion
- Presence of severe peripheral artery disease in legs
- Severe hypertension: Systolic > 200 mm/hg or Diastolic > 110 mm/hg
- Ankle brachial index < 0.8
- Neurologic or neurodegenerative disease other than stenosis that severly impairs the
ability to walk
- Presence of cauda equina symptoms (saddle paresthesia, progressive loss of
bladder/bowel function, etc)
Age minimum:
60 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lumbar Spinal Stenosis
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Intervention(s)
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Other: Individualized exercises: clinical setting
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Other: Joint Mobilizations (spine, sacroiliac, hip)
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Drug: NSAIDs; adjunctive analgesics; adjunctive anti-depressants
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Other: Group Exercise: community setting
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Procedure: Lumbar epidural injection
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Primary Outcome(s)
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Swiss Spinal Stenosis (SSS) Questionnaire Score
[Time Frame: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).]
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Secondary Outcome(s)
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Self Paced Walking Test (SPWT)
[Time Frame: Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).]
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Secondary ID(s)
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587
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PRO12120422
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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