Clinical Prediction Rule for Clinical Lumbar Instability
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|ClinicalTrials.gov Identifier: NCT01085448|
Recruitment Status : Terminated (lack of timely recruitment of subjects)
First Posted : March 11, 2010
Last Update Posted : November 5, 2013
The aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises.
Question: What clinical characteristics are associated with patients that respond positively to a program of core stabilization exercises?
Hypothesis: Clinical characteristics that show a decrease in trunk motor control will be associated with a positive response to stabilization exercises.
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Other: Core Stabilization||Not Applicable|
Clinical identification of individuals with mechanical low back pain who would benefit from a program of stabilization exercises has been a struggle for the physical therapy profession. While changes in trunk muscle recruitment and motor control have been linked to patients with chronic low back pain and hypothesized to be adaptations for spinal instability, this has not been systematically established. However, a connection between spinal instability, poor trunk motor control, and low back pain is plausible. The real problem lies with the clinical identification of the subgroup of patients in either the acute or chronic phases of low back dysfunction who would most benefit from this approach to intervention.
In creating their preliminary clinical prediction rule, Hicks et al (2005), looked at many variables including patient demographics and characteristics, hip and trunk motion, special tests for instability, and functional measures of muscle performance. However, measures of the performance of core stabilizing muscles and assessment of trunk dynamic control/ coordination were not included as potential variables. The aim of this study is to determine if assessment of additional measures of trunk neuromuscular control will improve the ability to identify patients with low back pain who successfully respond to trunk stabilization exercises.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Identifying the Subgroup of Patient With Mechanical Low Back Pain Who Have Clinical Lumbar Instability|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||October 2013|
Low back pain
Individuals with current low back pain.
Other: Core Stabilization
The 8-week program emphasizes use of specific local stabilizing muscles (transverse abdominis[TrA], lumbar multifidus[LM]) to restore active control to the trunk. Emphasis is on training isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm.
Stage 1: neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation.
Stage 2: maintenance the co-contraction while performing movements of the trunk and the upper and lower extremities. Trunk conditioning is also emphasized. Feedback is gradually reduced.
Stage 3: 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.
- Oswestry Disability Index [ Time Frame: Baseline, 8 weeks ]measure of functional limitation
- Numeric Pain Scale [ Time Frame: Baseline, 8 weeks ]measure of preceived pain
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 ClinicalTrials.gov identifier (NCT number): NCT01085448
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19102|
|Optimum Physical Therapy Associates|
|West Chester, Pennsylvania, United States, 19380|
|Principal Investigator:||Sheri P. Silfies, PT, PhD||Drexel University|