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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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19 February 2015 |
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Main ID: |
NCT01438203 |
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Date of registration:
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19/09/2011 |
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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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Thrust Manipulation Versus Non-Thrust Manipulation
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Scientific title:
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Early Use of Thrust Manipulation Versus Non-Thrust Manipulation: A Randomized Clinical Trial |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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149 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01438203 |
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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: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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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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Chad E Cook, 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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Walsh University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients, age 18 and older, with mechanically producible low back pain, who attend
care at a physical therapy outpatient setting, will be screened for eligibility for
the study.
- For patients to meet inclusion requirements, they had to display a within session
change in pain and/or range of motion during the assessment phase of the clinical
examination. In other words, as the clinician performed their assessment and applied
a passive accessory assessment technique, the pain and/or range of motion improved
during that session, which suggests a favorable outcome using a comparable treatment
technique. This is hallmark clinical finding in the patient response model and has
been proposed as both a predictor of a positive outcome and as a prognostic variable
toward long-term improvements in impairments.
Exclusion Criteria:
- The presence of any red flags (i.e., tumor, metabolic diseases, RA, osteoporosis,
prolonged history of steroid use, etc.)
- Signs consistent with nerve root compression (reproduction of low back or leg pain
with straight leg raise at less than 45°
- Muscle weakness involving a major muscle group of the lower extremity,
- Diminished lower extremity muscle stretch reflex
- Diminished or absent sensation to pinprick in any lower extremity dermatome)
- Other exclusion criteria included prior surgery to the lumbar spine and current
pregnancy
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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Mechanical Low Back Pain
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Intervention(s)
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Procedure: Non-thrust manipulation
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Procedure: Thrust manipulation
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Primary Outcome(s)
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Oswestry disability index
[Time Frame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.]
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Secondary Outcome(s)
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Numeric Pain Rating Scale (NPRS)
[Time Frame: Baseline to discharge from therapy services (up to 4 months). An expected average is 4 weeks.]
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Secondary ID(s)
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Walsh 10-24
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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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