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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00939107 |
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Date of registration:
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13/07/2009 |
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Primary sponsor: |
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Public title:
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The McKenzie Method Versus Manipulation for Patients With Chronic Low Back Pain
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Scientific title:
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The Effect of the McKenzie Method as Compared With That of Manipulation When Applied Adjunctive to Information and Advice for Patients With Clinical Signs of Disc-related Chronic Low Back Pain: Randomized Controlled Trial. |
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Date of first enrolment:
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September 2003 |
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Target sample size:
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350 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00939107 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Tom Petersen, PT,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Back and Rehabilitation Center Copenhagen, Copenhagen, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 to 60 years of age
- suffering from low back pain (LBP) with or without leg pain for a period of more than
6 weeks
- able to speak and understand the Danish language
- with a presentation of clinical signs of disc-related symptoms.
Exclusion Criteria:
- positive non-organic signs
- serious pathology suspected based on physical examination and/or magnetic resonance
imaging
- application for disability pension or pending litigation
- pregnancy
- comorbidity
- recent back surgery
- problems with communication
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Low Back Pain
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Intervention(s)
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Procedure: McKenzie exercises
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Procedure: spinal manipulation
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Primary Outcome(s)
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Disability
[Time Frame: two months after treatment]
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Number of Patients With Treatment Success
[Time Frame: Two months posttreatment]
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Secondary Outcome(s)
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Cost Effectiveness
[Time Frame: twelve months posttreatment]
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Number of Patients on Sick Leave
[Time Frame: twelve months posttreatment]
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Pain
[Time Frame: twelve months posttreatment]
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Quality of Life
[Time Frame: twelve months posttreatment]
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Secondary ID(s)
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KF-01-057/03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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