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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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22 April 2013 |
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Main ID: |
NCT01211613 |
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Date of registration:
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28/09/2010 |
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Primary sponsor: |
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Public title:
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Chiropractic Manipulation and Medical Care for Low Back Pain
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Scientific title:
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A Comparison of Chiropractic Manipulation Methods and Standard Medical Care for Low Back Pain |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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106 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01211613 |
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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: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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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:
- Age: = 18 years of age
- Ability to read and write English
- Experiencing a new episode of low back pain with onset in the past 3 months
- Oswestry Disability Index score between 20-70 points (0-100 scale)
- Numeric pain rating score between 3-8 points (0-10 scale)
Exclusion Criteria:
- Prior history of lumbar spine surgery
- History of unstable spondylolisthesis, spinal stenosis, or scoliosis > 20°
- Signs or symptoms suggestive of nerve root tension and/or neurological deficit in the
lower extremity
- History of metastatic cancer, osteoporosis, long-term corticosteroid use, or any
other red flags of serious illness including the following: unexplained weight loss
of >10% of body weight, spinal pain associated with fever, and severe night pain
unrelieved by medication
- Receiving any physical therapy, chiropractic therapy, or any other manual therapy for
this episode of LBP (within the past 3 months)
- Receiving any on-going medical care for this episode of low back pain
- Current use of opiate or other prescription medications for low back pain
Age minimum:
18 Years
Age maximum:
N/A
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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Device: Mechanically-assisted manipulation
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Other: Standard Medical Care
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Procedure: Manual Manipulation
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Primary Outcome(s)
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Oswestry Low Back Pain Disability Index
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Numeric Pain Rating Score
[Time Frame: 4 weeks]
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Secondary ID(s)
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4R00AT004196-03
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PRO10040327
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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