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Clinical Prediction Rule for Clinical Lumbar Instability

This study is currently recruiting participants.
Verified February 2013 by Drexel University
Sponsor:
Information provided by (Responsible Party):
Sheri Silfies, Drexel University
ClinicalTrials.gov Identifier:
NCT01085448
First received: March 10, 2010
Last updated: February 24, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Low Back Pain
 Other: Core Stabilization

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Identifying the Subgroup of Patient With Mechanical Low Back Pain Who Have Clinical Lumbar Instability

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    measure of functional limitation


Secondary Outcome Measures:
  • Numeric Pain Scale [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    measure of preceived pain


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. duration of the current episode of low back pain less than 3 months,
  2. average pain intensity over past 3 days at least 4 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 score greater than 25%

Exclusion Criteria:

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085448

Locations
United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Sheri Silfies, PT, PhD     215-762-3589     silfies@drexel.edu    
Contact: Won Sung, DPT     215-762-3589     wss26@drexel.edu    
Optimum Physical Therapy Associates Recruiting
West Chester, Pennsylvania, United States, 19380
Contact: Scott Biely, PT, DPT     610-349-6997     sbiely@aol.com    
Sponsors and Collaborators
Drexel University
Investigators
Principal Investigator: Sheri P. Silfies, PT, PhD Drexel University
  More Information

No publications provided

Responsible Party: Sheri Silfies, Associate Professor, Drexel University
ClinicalTrials.gov Identifier: NCT01085448     History of Changes
Other Study ID Numbers: DRX18590
Study First Received: March 10, 2010
Last Updated: February 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
low back pain
core stabilization
physical therapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013