Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sharon M. Henry, University of Vermont
ClinicalTrials.gov Identifier:
NCT01611792
First received: June 1, 2012
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Other: Stabilization exercise protocol
Other: Strength and conditioning exercise protocol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Change from baseline in Oswestry Disability Scale (0-100%) [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Oswestry Disability Scale (0-100%) [ Time Frame: Baseline and 6 Months ] [ Designated as safety issue: No ]
  • Change from baseline in Oswestry Disability Scale (0-100%) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change from 10 weeks in Oswestry Disability Scale (0-100%) [ Time Frame: 10 Weeks and 6 Months ] [ Designated as safety issue: No ]
  • Change from 10 weeks in Oswestry Disability Scale (0-100%) [ Time Frame: 10 Weeks and 12 Months ] [ Designated as safety issue: No ]
  • Change from 6 months in Oswestry Disability Scale (0-100%) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in Numeric Pain Rating Scale (0-10 points) [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Numeric Pain Rating Scale (0-10 points) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in Numeric Pain Rating Scale (0-10 points) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change from 10 weeks in Numeric Pain Rating Scale (0-10 points) [ Time Frame: 10 weeks and 6 months ] [ Designated as safety issue: No ]
  • Change from 6 weeks in Numeric Pain Rating Scale (0-10 points) [ Time Frame: 10 weeks and 12 months ] [ Designated as safety issue: No ]
  • Change from 6 months in Numeric Pain Rating Scale (0-10 points) [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: March 2003
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low back pain Other: 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.
Other Names:
  • Trunk stabilization exercises
  • Segmental stabilization exercises
Other: 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.
Other Names:
  • General trunk exercise
  • General strength training

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611792

Locations
United States, Vermont
Human Motion Analysis Laboratory
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Sharon M Henry, PT, PhD University of Vermont
  More Information

No publications provided

Responsible Party: Sharon M. Henry, Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT01611792     History of Changes
Other Study ID Numbers: NIH/NCMRR/R01-HD040909
Study First Received: June 1, 2012
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Stabilization exercise
Strength and conditioning exercise
Physical therapy
Rehabilitation

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014