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 5, 2015
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sheri Silfies, Drexel University

March 10, 2010
March 12, 2010
August 5, 2015
August 2009
April 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01085604 on Archive Site
Oswestry Disability Index [ Time Frame: Baseline, 8 weeks ]
measure of functional limitations
Same as current
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Recurrent Low Back Pain:Linking Mechanisms to Outcomes
Recurrent Low Back Pain:Linking Mechanisms to Outcomes

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.
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.
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
primary care clinic physical therapy clinic community
Low Back Pain
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.

Low back pain
Individuals with current low back pain attributed to poor trunk neuromuscular control (clinical instability).
Intervention: Other: Core Stabilization
Sung W, Abraham M, Plastaras C, Silfies SP. Trunk motor control deficits in acute and subacute low back pain are not associated with pain or fear of movement. Spine J. 2015 Aug 1;15(8):1772-82. doi: 10.1016/j.spinee.2015.04.010. Epub 2015 Apr 8.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
K01HD053632 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Sheri Silfies, Drexel University
Drexel University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Sheri P. Silfies, PT, PhD Drexel University
Drexel University
August 2015