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Clinical Trials/NCT01611792
NCT01611792
Completed
Not Applicable

Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain

University of Vermont1 site in 1 country58 target enrollmentMarch 2003
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
University of Vermont
Enrollment
58
Locations
1
Primary Endpoint
Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
June 2008
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sharon M. Henry

Professor

University of Vermont

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

Study Sites (1)

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