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Completed

NCT Number: NCT01085604

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Drexel University, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for healthy controls:

No history of low back is defined as:

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

Inclusion criteria

for individuals with a history of low back pain:

  • duration of the current episode of low back pain less than 3 months,
  • 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,
  • no medical intervention for low back pain in last 6 months,
  • Oswestry disability score greater than 20%
  • a physical therapy diagnosis of clinical lumbar instability based upon specific examination findings.

Exclusion criteria

for both groups:

  • permanent structural spinal deformity (e.g., scoliosis)
  • history of spinal fracture or diagnosis of osteoporosis
  • diagnosis of inflammatory joint disease
  • signs of systemic illness or suspected non-mechanical LBP (i.e. spinal tumor or infection)
  • previous spinal surgery
  • frank neurological loss, i.e., weakness and sensory loss
  • history of neurologic disease that required hospitalization,
  • 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
  • leg length discrepancy of greater than 2.5 cm.
  • pregnancy
  • vestibular dysfunction

Treatment and study plan

Core Stabilization

Other

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 outcomes

  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 outcomes

  1. Oswestry Disability Index

    Time frame: Baseline, 8 weeks

    measure of functional limitations

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

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

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Mar 12, 2010
Registry last updated
Aug 2, 2018

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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