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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Low back pain affects 80% of Americans at some time during their lives. Although recovery usually occurs within 6 months, there is a 50% recurrence within one year's time. It has long been thought that poor control of trunk muscle may lead to abnormal forces across the spine, which then damage local spinal structures, thus, leading to low back pain. However, the investigators know little about the function of specific trunk muscles in healthy subjects during various activities of daily life. Furthermore, the precise muscle dysfunction associated with low back pain has not been well characterized at all. In addition, the investigators know little about which exercise protocol is most beneficial for particular subgroups of people with low back pain. Thus, the purposes of this study are to learn more about: 1) how trunk muscles are affected by low back pain; 2) which exercises might be most beneficial for people with certain kinds of low back pain; and 3) how these exercises influence trunk muscle function. By having a better understanding of which trunk muscles are affected by low back pain, rehabilitation specialists can design exercise programs and therapeutic interventions that are more specific and more effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stabilization | Experimental |
| |
| Strengthening and Conditioning | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stabilization exercise protocol | Other | The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%) | Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement | Baseline and 11 weeks |
| Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%) | Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement | Baseline and 6 Months |
| Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%) | Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement | 11 Weeks and 6 Months |
| Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points) | Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement | Baseline and 11 weeks |
| Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points) | Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement | Baseline and 6 months |
| Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points) | Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement | 11 weeks and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon M Henry, PT, PhD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Motion Analysis Laboratory | Burlington | Vermont | 05405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22100719 | Background | Jones SL, Henry SM, Raasch CC, Hitt JR, Bunn JY. Individuals with non-specific low back pain use a trunk stiffening strategy to maintain upright posture. J Electromyogr Kinesiol. 2012 Feb;22(1):13-20. doi: 10.1016/j.jelekin.2011.10.006. Epub 2011 Nov 18. | |
| 21795622 | Background | Jacobs JV, Henry SM, Jones SL, Hitt JR, Bunn JY. A history of low back pain associates with altered electromyographic activation patterns in response to perturbations of standing balance. J Neurophysiol. 2011 Nov;106(5):2506-14. doi: 10.1152/jn.00296.2011. Epub 2011 Jul 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Back Pain | Stabilization Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities. |
| FG001 | Strengthening and Conditioning | Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Period: Time 0 |
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| Follow-up: at 11 Weeks |
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| Followup: at 6 Months |
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Based on subjects who completed the 10 week treatment protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | Stabilization | Stabilization Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%) | Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement | Based on data reported and available | Posted | Mean | Standard Deviation | units on a scale | Baseline and 11 weeks |
|
From Baseline to completion of study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stabilization | Stabilization Stabilization exercise protocol: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon M. Henry | University of Vermont Medical Center, Burlington, VT | 802 847-6733 | Sharon.Henry@uvm.edu |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Strength and conditioning exercise protocol | Other | This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises. |
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| 21571410 | Background | Stokes IA, Gardner-Morse MG, Henry SM. Abdominal muscle activation increases lumbar spinal stability: analysis of contributions of different muscle groups. Clin Biomech (Bristol). 2011 Oct;26(8):797-803. doi: 10.1016/j.clinbiomech.2011.04.006. Epub 2011 May 14. |
| 20655636 | Background | Stokes IA, Gardner-Morse MG, Henry SM. Intra-abdominal pressure and abdominal wall muscular function: Spinal unloading mechanism. Clin Biomech (Bristol). 2010 Nov;25(9):859-66. doi: 10.1016/j.clinbiomech.2010.06.018. Epub 2010 Jul 23. |
| 18299821 | Background | Jones SL, Henry SM, Raasch CC, Hitt JR, Bunn JY. Responses to multi-directional surface translations involve redistribution of proximal versus distal strategies to maintain upright posture. Exp Brain Res. 2008 May;187(3):407-17. doi: 10.1007/s00221-008-1312-1. Epub 2008 Feb 26. |
| 17877281 | Background | Teyhen DS, Gill NW, Whittaker JL, Henry SM, Hides JA, Hodges P. Rehabilitative ultrasound imaging of the abdominal muscles. J Orthop Sports Phys Ther. 2007 Aug;37(8):450-66. doi: 10.2519/jospt.2007.2558. |
| 17970410 | Background | Henry SM, Teyhen DS. Ultrasound imaging as a feedback tool in the rehabilitation of trunk muscle dysfunction for people with low back pain. J Orthop Sports Phys Ther. 2007 Oct;37(10):627-34. doi: 10.2519/jospt.2007.2555. |
| Background | Anderson-Worth SG, Henry SM, Bunn JY. Use of real time ultrasound feedback enhances learning the abdominal hollowing exercise in patients with low back pain. New Zealand J Physiotherapy. 35(1):4-11, 2007. |
| 16806618 | Background | Henry SM, Hitt JR, Jones SL, Bunn JY. Decreased limits of stability in response to postural perturbations in subjects with low back pain. Clin Biomech (Bristol). 2006 Nov;21(9):881-92. doi: 10.1016/j.clinbiomech.2006.04.016. Epub 2006 Jun 27. |
| 16001905 | Background | Henry SM, Westervelt KC. The use of real-time ultrasound feedback in teaching abdominal hollowing exercises to healthy subjects. J Orthop Sports Phys Ther. 2005 Jun;35(6):338-45. doi: 10.2519/jospt.2005.35.6.338. |
| 24853255 | Background | Lomond KV, Henry SM, Hitt JR, DeSarno MJ, Bunn JY. Altered postural responses persist following physical therapy of general versus specific trunk exercises in people with low back pain. Man Ther. 2014 Oct;19(5):425-32. doi: 10.1016/j.math.2014.04.007. Epub 2014 Apr 24. |
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| BG001 | Strengthening and Conditioning | Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Numeric Pain Index | Current Pain; Scale 0-10; Lower score is better/improved; Collected on paper; patient self-report | Mean | Standard Deviation | units on a scale |
|
| Modified Oswestry Disability Index | Disability; Sacle 0-100%; Lower score is considered better/improve; Collected on paper; patient self-report | Mean | Standard Deviation | units on a scale |
|
| OG001 | Strengthening and Conditioning | Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises. |
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| Primary | Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%) | Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement | Based on data reported and available | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 Months |
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| Primary | Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%) | Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement | Based on data reported and available | Posted | Mean | Standard Deviation | units on a scale | 11 Weeks and 6 Months |
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| Primary | Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points) | Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement | Based on data reported and available | Posted | Mean | Standard Deviation | units on a scale | Baseline and 11 weeks |
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| Primary | Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points) | Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement | Based on data reported and available | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
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| Primary | Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points) | Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement | Based on data reported and available | Posted | Mean | Standard Deviation | units on a scale | 11 weeks and 6 months |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Strengthening and Conditioning | Strength and conditioning exercise protocol: This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |