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Recurrent Low Back Pain:Linking Mechanisms to Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01085604
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : August 2, 2018
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sheri Silfies, Drexel University

Brief Summary:

The purpose of this study is to determine if trunk neuromuscular control strategies are changed by therapeutic exercises emphasizing core stabilization.

Hypothesis: subjects with low back pain who demonstrate clinically meaningful improvements in function and pain will have significantly improved trunk motor control strategies.

Hypothesis: measures of trunk control will demonstrate 'construct-validity'. This will be tested using a known group method demonstrating:

  • no significant change in motor control measures within the untreated, healthy control group.
  • significant changes within the low back subjects who demonstrate clinically meaningful improvements.

Condition or disease Intervention/treatment
Low Back Pain Other: Core Stabilization

Detailed Description:
A growing body of evidence suggests that poor neuromuscular control of the lumbopelvic region is an important finding in a large number of patients with recurrent and chronic low back pain and may play a role in recurrence of symptoms. Despite findings of altered trunk motor control in individuals with low back pain, the neuromuscular strategies underlying these alterations have not been satisfactorily characterized. The aims of this study are to(1) identify which neural control strategies are altered following a rehabilitation program that emphasizes trunk control and stability using a motor learning approach and (2) provide preliminary evidence of a link between hypothesized mechanism and effectiveness for programs designed to improve trunk control.

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Recurrent Low Back Pain:Linking Mechanisms to Outcomes
Study Start Date : August 2009
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort Intervention/treatment
Low back pain
Individuals with current low back pain attributed to poor trunk neuromuscular control (clinical instability).
Other: Core Stabilization

The 8-week core stabilization program emphasizes use of specific local stabilizing muscles (transverse abdominis[TrA], lumbar multifidus[LM]) to restore active control and stability to the trunk. This program emphasizes training using isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm.

Stage 1: emphasizes neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation.

Stage 2: promotes maintenance the co-contraction while performing movements of the trunk and superimposing movements of the upper and lower extremities. Trunk conditioning is also emphasized (i.e., curl ups, quadruped leg/arm lifts and side support). Feedback is gradually reduced.

Stage 3: emphasis on maintenance of the co-contraction while performing exercises on an unstable surface or during perturbation of the activity. Random practice patterns are used to enhance motor learning.

Primary Outcome Measures :
  1. Trunk Neuromuscular Control [ Time Frame: Baseline, 8 weeks ]
    Using surface EMG, trunk kinematics and force plate parameters. Trunk motor control is characterized and compared between groups and pre/post intervention in the low back pain group.

Secondary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: Baseline, 8 weeks ]
    measure of functional limitations

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic physical therapy clinic community

Inclusion criteria for healthy controls:

No history of low back is defined as:

  1. no pain limiting performance of daily activities for greater than 3 days,
  2. no pain for which they sought medical or allied health intervention.

Inclusion Criteria for individuals with a history of low back pain:

  1. duration of the current episode of low back pain less than 3 months,
  2. average pain intensity over past 2 weeks at least 3 on an 11 point (0 = no pain, 10 = worst pain ever) numeric pain rating scale,
  3. no medical intervention for low back pain in last 6 months,
  4. Oswestry disability score greater than 20%
  5. a physical therapy diagnosis of clinical lumbar instability based upon specific examination findings.

Exclusion Criteria for both groups:

  1. permanent structural spinal deformity (e.g., scoliosis)
  2. history of spinal fracture or diagnosis of osteoporosis
  3. diagnosis of inflammatory joint disease
  4. signs of systemic illness or suspected non-mechanical LBP (i.e. spinal tumor or infection)
  5. previous spinal surgery
  6. frank neurological loss, i.e., weakness and sensory loss
  7. history of neurologic disease that required hospitalization,
  8. active treatment of another medical illness that would preclude participation in any aspect of the study or any lower extremity injury that would potentially alter trunk movement in standing
  9. leg length discrepancy of greater than 2.5 cm.
  10. pregnancy
  11. vestibular dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01085604

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United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
Optimum Physical Therapy Associates
West Chester, Pennsylvania, United States, 19380
Sponsors and Collaborators
Drexel University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Sheri P. Silfies, PT, PhD Drexel University
Publications of Results:
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Responsible Party: Sheri Silfies, Associate Professor, Drexel University Identifier: NCT01085604    
Other Study ID Numbers: K01HD053632T
K01HD053632 ( U.S. NIH Grant/Contract )
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Keywords provided by Sheri Silfies, Drexel University:
low back pain
clinical instability
neuromuscular control
core stabilization
physical therapy
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms