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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: |
NCT03118271 |
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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 Traction, Spinal Manipulation, and Surgery in the Treatment of Lumbar Disc Herniation
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Scientific title:
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Comparison of the Effect of Lumbar Traction, Spinal Manipulation, and Surgery in the Treatment of Lumbar Disc Herniation |
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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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60 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03118271 |
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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:
- Age>20 and less than 80 y/o with LDH with moderate to severe (VAS pain > 4) LBP and/or
sciatica. LDH should be proved by MRI of the lumbosacral spine. The duration of pain
is less than 1 month.
Exclusion Criteria:
1. LBP probable due to serious spinal pathology such as spinal tumor, infection, and
inflammatory disease such as ankylosing spondylitis.28
2. LDH with progressive weakness in the lower extremities or symptoms and signs
suggesting cauda equina lesion.
3. Concomitant serious medical conditions.
4. History of spinal surgery before.
5. Severe osteoporosis or image studies suggesting instability of the lumbosacral 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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Lumbar Traction
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Lumbar Disc Herniation
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Spinal Manipulation
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Lumbar 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 and post-treatment 2 months after treatments.]
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Secondary Outcome(s)
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SF-36
[Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.]
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Global impression of change
[Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.]
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Modified Oswestry Disability Questionnaire (MODQ)
[Time Frame: Clinical evaluation will be conducted at pre-treatment, post-treatment day 7 and post-treatment 2 months after treatments.]
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Secondary ID(s)
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20160806R
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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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