Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Stabilization exercise protocol; Other: Strength and conditioning exercise protocol

• Registration Number: NCT01611792
• Lead Sponsor: University of Vermont

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2012-06-01
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Results First Submitted: 2017-02-20
• Results First Submitted QC: 2017-07-19
• Results First Posted: 2017-08-21
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stabilization	Stabilization exercise protocol	-
Strengthening and Conditioning	Strength and conditioning exercise protocol	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)	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%)	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)	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%)	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)	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)	11 weeks and 6 months	Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement

Trial Locations

Locations (1)

Human Motion Analysis Laboratory; 🇺🇸 Burlington, Vermont, United States