Recurrent Low Back Pain:Linking Mechanisms to Outcomes
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| First Received Date ICMJE | March 10, 2010 | ||||
| Last Updated Date | February 24, 2013 | ||||
| Start Date ICMJE | August 2009 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Trunk Neuromuscular Control [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ] Using surface EMG, trunk kinematics and force plate parameters. Trunk motor control is characterized and compared between groups and pre/post intervention in the low back pain group. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01085604 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Oswestry Disability Index [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ] measure of functional limitations |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Recurrent Low Back Pain:Linking Mechanisms to Outcomes | ||||
| Official Title ICMJE | Recurrent Low Back Pain:Linking Mechanisms to Outcomes | ||||
| Brief Summary | The purpose of this study is to determine if trunk neuromuscular control strategies are changed by therapeutic exercises emphasizing core stabilization. Hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in function and pain will have significantly improved trunk motor control strategies. Hypothesis: measures of trunk control will demonstrate 'construct-validity'. This will be tested using a known group method demonstrating:
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| Detailed Description | A growing body of evidence suggests that poor neuromuscular control of the lumbopelvic region is an important finding in a large number of patients with recurrent and chronic low back pain and may play a role in recurrence of symptoms. Despite findings of altered trunk motor control in individuals with low back pain, the neuromuscular strategies underlying these alterations have not been satisfactorily characterized. The aims of this study are to(1) identify which neural control strategies are altered following a rehabilitation program that emphasizes trunk control and stability using a motor learning approach and (2) provide preliminary evidence of a link between hypothesized mechanism and effectiveness for programs designed to improve trunk control. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | primary care clinic physical therapy clinic community |
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| Condition ICMJE | Low Back Pain | ||||
| Intervention ICMJE | Other: Core Stabilization
The 8-week core stabilization program emphasizes use of specific local stabilizing muscles (transverse abdominis[TrA], lumbar multifidus[LM]) to restore active control and stability to the trunk. This program emphasizes training using isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm. Stage 1: emphasizes neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation. Stage 2: promotes maintenance the co-contraction while performing movements of the trunk and superimposing movements of the upper and lower extremities. Trunk conditioning is also emphasized (i.e., curl ups, quadruped leg/arm lifts and side support). Feedback is gradually reduced. Stage 3: emphasis on maintenance of the co-contraction while performing exercises on an unstable surface or during perturbation of the activity. Random practice patterns are used to enhance motor learning. |
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| Study Group/Cohort (s) | Low back pain
Individuals with current low back pain attributed to poor trunk neuromuscular control (clinical instability).
Intervention: Other: Core Stabilization |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | August 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria for healthy controls: No history of low back is defined as:
Inclusion Criteria for individuals with a history of low back pain:
Exclusion Criteria for both groups:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01085604 | ||||
| Other Study ID Numbers ICMJE | K01HD053632T, K01HD053632 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sheri Silfies, Drexel University | ||||
| Study Sponsor ICMJE | Drexel University | ||||
| Collaborators ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Investigators ICMJE |
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| Information Provided By | Drexel University | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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