Effects of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity
| Tracking Information | |||||
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| First Received Date ICMJE | June 25, 2012 | ||||
| Last Updated Date | February 26, 2013 | ||||
| Start Date ICMJE | July 2012 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Electromyography (EMG) [ Time Frame: The EMG data will be collected within 48 hours for all participants in both groups. On Day 1, data will be collected twice at baseline. On Day 2, data will be collected before and immediately after as well as 15, 30, and 45 min after the intervention. ] [ Designated as safety issue: No ] Electromyography (EMG) onset time of the gluteus maximus, gluteus medius, vastus medialis oblique, and vastus lateralis muscles. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01637480 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Pain Visual Analog Scale (VAS) [ Time Frame: The Pain Visual Analog Scale (VAS) will be assessed before and 45 min after the lower back treatment (lumbopelvic manipulation) for participants in the patellofemoral pain syndrome group on Day 2 only. ] [ Designated as safety issue: No ] Pain Visual Analog Scale (VAS) is a 100 mm continuous line between two end-points. The left end-point represents "no pain" and the right end-point represents the "worst pain imaginable". |
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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 | Effects of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity | ||||
| Official Title ICMJE | Effects of Lumbopelvic Manipulation on Hip and Knee Neuromuscular Activity in People With and Without Patellofemoral Pain Syndrome | ||||
| Brief Summary | The purpose of this study is to determined if a lower back treatment would change the hip and knee muscle activities in people with and without anterior knee pain. The investigators hypothesized that the lower back treatment may change the hip and knee muscle activities in people with anterior knee pain but not in people without anterior knee pain. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Patellofemoral Pain Syndrome | ||||
| Intervention ICMJE | Other: Lumbopelvic manipulation
High-velocity-low-amplitude thrust manipulation of the lumbopelvic region |
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| Study Arm (s) |
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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 | 30 | ||||
| Estimated Completion Date | May 2013 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria for participants in the patellofemoral pain syndrome group:
Exclusion criteria for all participants:
Age- and gender- matched control participants will be recruited if they have no signs or symptoms of patellofemoral pain syndrome and have none of the exclusion criteria |
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01637480 | ||||
| Other Study ID Numbers ICMJE | 16882 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Texas Woman's University | ||||
| Study Sponsor ICMJE | Texas Woman's University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Texas Woman's 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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