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Completed

NCT Number: NCT01611792

Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain

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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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Motion Analysis Laboratory

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Trunk stabilization exercises, Segmental stabilization exercises

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.

Other names: General trunk exercise, General strength training

Primary outcomes

  1. Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)

    Time frame: Baseline and 11 weeks

    Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement

  2. Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)

    Time frame: Baseline and 6 Months

    Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement

  3. Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)

    Time frame: 11 Weeks and 6 Months

    Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement

  4. Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)

    Time frame: Baseline and 11 weeks

    Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement

  5. Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)

    Time frame: Baseline and 6 months

    Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement

  6. Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)

    Time frame: 11 weeks and 6 months

    Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jun 5, 2012
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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