NCT01611792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

August 21, 2017

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

5.3 years

First QC Date

June 1, 2012

Results QC Date

February 20, 2017

Last Update Submit

October 16, 2017

Conditions

Keywords

Stabilization exerciseStrength and conditioning exercisePhysical therapyRehabilitation

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Stabilization

EXPERIMENTAL
Other: Stabilization exercise protocol

Strengthening and Conditioning

ACTIVE COMPARATOR
Other: Strength and conditioning exercise protocol

Interventions

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.

Also known as: Trunk stabilization exercises, Segmental stabilization exercises
Stabilization

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.

Also known as: General trunk exercise, General strength training
Strengthening and Conditioning

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Motion Analysis Laboratory

Burlington, Vermont, 05405, United States

Location

Related Publications (11)

  • 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.

    PMID: 22100719BACKGROUND
  • 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.

    PMID: 21795622BACKGROUND
  • 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.

    PMID: 21571410BACKGROUND
  • 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.

    PMID: 20655636BACKGROUND
  • 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.

    PMID: 18299821BACKGROUND
  • 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.

    PMID: 17877281BACKGROUND
  • 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.

    PMID: 17970410BACKGROUND
  • 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.

    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.

    PMID: 16806618BACKGROUND
  • 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.

    PMID: 16001905BACKGROUND
  • 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.

    PMID: 24853255BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Sharon M. Henry
Organization
University of Vermont Medical Center, Burlington, VT

Study Officials

  • Sharon M Henry, PT, PhD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2012

First Posted

June 5, 2012

Study Start

March 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

October 18, 2017

Results First Posted

August 21, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations