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

March 10, 2010
March 26, 2014
August 2009
April 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01085604 on ClinicalTrials.gov Archive Site
Oswestry Disability Index [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
measure of functional limitations
Same as current
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
June 2014
April 2014   (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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01085604
K01HD053632T, K01HD053632
No
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
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP