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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: |
NCT03118206 |
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Date of registration:
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07/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis
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Scientific title:
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Comparison of the Effect of Lumbar Spinal Manipulation, Physical Therapy and Surgical Management in the Treatment of Lumbar Spinal Stenosis |
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Date of first enrolment:
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January 2017 |
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Target sample size:
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14 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03118206 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Lin-Fen Hsieh, M.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shin Kong Wu Ho-Su Memorial Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age between 20 to 80 age years old
2. Moderate to severe low back painand/or sciatica,and/or intermittent claudication
(VAS>=4)
3. Symptom duration is more than three months
4. The diagnosis is proved by MRI
Exclusion Criteria:
1. Serious spinal pathologies including spinal tumor, infection, andinflammatory disease
2. Progressive weakness, sensory loss or symptoms and signs suggesting cauda equine esion
3. Concomitant serious medical conditions
4. History of spinal surgery before
5. Severe osteoporosis or instability of the lumbar spine
Age minimum:
20 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spinal Manipulation
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Lumbar Spinal Stenosis
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Physical Therapy
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Surgery
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Intervention(s)
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Procedure: spinal manipulation
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Device: lumbar traction
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Procedure: surgery
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Primary Outcome(s)
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VAS pain score
[Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.]
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Secondary Outcome(s)
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Modified OswestryDisability Questionnaire (MODQ)
[Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.]
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Swiss Spinal Stenosis Questionnaire
[Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.]
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Intermittent claudication
[Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.]
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The Medical Outcome Survey Short Form (SF-36)
[Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7, post-treatment 3 months and post-treatment 6 months after treatments.]
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Secondary ID(s)
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20160804R
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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