search
Back to results

Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stabilization exercise protocol
Strength and conditioning exercise protocol
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Stabilization exercise, Strength and conditioning exercise, Physical therapy, Rehabilitation

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Human Motion Analysis Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stabilization

Strengthening and Conditioning

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
June 1, 2012
Last Updated
October 16, 2017
Sponsor
University of Vermont
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT01611792
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Stabilization exercise, Strength and conditioning exercise, Physical therapy, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stabilization
Arm Type
Experimental
Arm Title
Strengthening and Conditioning
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Stabilization exercise protocol
Other Intervention Name(s)
Trunk stabilization exercises, Segmental stabilization exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Strength and conditioning exercise protocol
Other Intervention Name(s)
General trunk exercise, General strength training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)
Description
Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement
Time Frame
Baseline and 11 weeks
Title
Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)
Description
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
Time Frame
Baseline and 6 Months
Title
Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)
Description
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
Time Frame
11 Weeks and 6 Months
Title
Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)
Description
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Time Frame
Baseline and 11 weeks
Title
Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)
Description
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Time Frame
Baseline and 6 months
Title
Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)
Description
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Time Frame
11 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon M Henry, PT, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Motion Analysis Laboratory
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22100719
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.
Results Reference
background
PubMed Identifier
21795622
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.
Results Reference
background
PubMed Identifier
21571410
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, Avon). 2011 Oct;26(8):797-803. doi: 10.1016/j.clinbiomech.2011.04.006. Epub 2011 May 14.
Results Reference
background
PubMed Identifier
20655636
Citation
Stokes IA, Gardner-Morse MG, Henry SM. Intra-abdominal pressure and abdominal wall muscular function: Spinal unloading mechanism. Clin Biomech (Bristol, Avon). 2010 Nov;25(9):859-66. doi: 10.1016/j.clinbiomech.2010.06.018. Epub 2010 Jul 23.
Results Reference
background
PubMed Identifier
18299821
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.
Results Reference
background
PubMed Identifier
17877281
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.
Results Reference
background
PubMed Identifier
17970410
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
16806618
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, Avon). 2006 Nov;21(9):881-92. doi: 10.1016/j.clinbiomech.2006.04.016. Epub 2006 Jun 27.
Results Reference
background
PubMed Identifier
16001905
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.
Results Reference
background
PubMed Identifier
24853255
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.
Results Reference
background

Learn more about this trial

Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain

We'll reach out to this number within 24 hrs