Clinical trial NCT01611792: Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain
Official title: Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Stabilization exercise
Strength and conditioning exercise
Physical therapy
Rehabilitation
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-06-05
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* a history of chronic LBP with or without recurrences for a minimum of 12 months
* between 21 - 55 years of age
* able to stand and walk without assistance
* have an Oswestry Disability Score of 19% or higher

Exclusion Criteria:

* any major structural spinal deformity including scoliosis, kyphosis, or stenosis
* spinal fracture or dislocation
* osteoporosis
* ankylosing spondylitis
* rheumatoid arthritis
* disc herniation with corroborating clinical signs and symptoms
* serious spinal complications such as tumor or infection
* previous spinal surgery
* frank neurological loss, i.e., weakness and sensory loss
* pain or paresthesia below the knee
* etiology of LBP other than the lumbar spine, e.g., hip joint
* history of neurological disease which required hospitalization
* active treatment for cancer
* history of unresolved cancer
* pregnancy or less than 6 months post-partum or less than 6 months post weaning
* magnified symptom-behavior
* worker's compensation or disability case
* in litigation for the LBP problem
* have a BMI ≥ 30

Primary outcomes:
measure: Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)
timeFrame: Baseline and 11 weeks
measure: Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)
timeFrame: Baseline and 6 Months
measure: Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)
timeFrame: 11 Weeks and 6 Months
measure: Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)
timeFrame: Baseline and 11 weeks
measure: Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)
timeFrame: Baseline and 6 months
measure: Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)
timeFrame: 11 weeks and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Human Motion Analysis Laboratory
state: Vermont
Study officials:
affiliation: University of Vermont
name: Sharon M Henry, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.