Recurrent Low Back Pain:Linking Mechanisms to Outcomes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sheri Silfies, Drexel University
ClinicalTrials.gov Identifier:
NCT01085604
First received: March 10, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention
Low Back Pain
Other: Core Stabilization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Recurrent Low Back Pain:Linking Mechanisms to Outcomes

Resource links provided by NLM:


Further study details as provided by Drexel University:

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


Estimated Enrollment: 80
Study Start Date: August 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic physical therapy clinic community

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085604

Locations
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
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: NCT01085604     History of Changes
Other Study ID Numbers: K01HD053632T, K01HD053632
Study First Received: March 10, 2010
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
low back pain
clinical instability
neuromuscular control
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 August 28, 2014