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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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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000162516 |
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Date of registration:
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19/02/2015 |
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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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Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group.
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Scientific title:
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Effect of lumbar fusion versus nonsurgical treatment on pain and function in patients with chronic low back pain |
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Date of first enrolment:
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01/01/1992 |
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Target sample size:
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294 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12615000162516.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Mr Christer Johansson
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Address:
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Sahlgrenska University Hospital
Institution of Clinical Sciences
Department of Orthopedics
Bruna straket 11 b
413 57 Gothenburg
Sweden |
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Telephone:
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+46313434060 |
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Email:
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bc.chaplin@gmail.com |
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Affiliation:
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Name:
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Mr Christer Johansson
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Address:
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Sahlgrenska University Hospital
Institution of Clinical Sciences
Department of Orthopedics
Bruna straket 11 b
413 57 Gothenburg
Sweden |
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Telephone:
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+46701406266 |
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Email:
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bc.chaplin@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with chronic low back pain for at least 2 years and with radiologic evidence of disc degeneration at L4-L5 or L5-S1. Back pain more pronounced than leg pain and no signs of nerve root compression. The patients must have been on sick leave for at least 1 year and nonsurgical treatment efforts should have been unsuccessful.
Exclusion criteria: Ongoing psychiatric illness.
Previous spine surgery except for successful removal of herniated disc.
Infection or inflammatory process.
Age minimum:
25 Years
Age maximum:
65 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Chronic Low Back Pain;
Chronic Low Back Pain
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Musculoskeletal - Other muscular and skeletal disorders
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Intervention(s)
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Spinal fusion is surgery to permanently connect two or more vertebrae in your spine, eliminating motion between them.
Spinal fusion involves techniques designed to mimic the normal healing process of broken bones. During spinal fusion, the surgeon places bone or a bone-like material in the space between two spinal vertebrae. Metal plates, screws and rods may be used to hold the vertebrae together, so they can heal into one solid unit. The procedure takes approximate 1-3 hours to complete.
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Primary Outcome(s)
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Patient overall assessment. The result, according to the patient’s own opinion, was reflected in response to the question, “Compared with before treatment my back problems are: ‘much better, better, unchanged, or worse’.”[2 year]
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Secondary Outcome(s)
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Visual analogue scale for back-and leg pain.[2 year]
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Oswestry Disability Index[2 year]
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General function score[2 year]
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Zung depression score[2 year]
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Source(s) of Monetary Support
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Ossano Scandinavia AB
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Acromed Corporation
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Ethics review
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Status: Approved
Approval date:
Contact:
Regional Ethic Committee in Gothenburg
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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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