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Clinical Trials/NCT01360359
NCT01360359
Completed
N/A

Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)

Drexel University2 sites in 1 country17 target enrollmentMay 2011
ConditionsLow Back Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Drexel University
Enrollment
17
Locations
2
Primary Endpoint
Trunk Neuromuscular Control
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this randomized clinical trial of low back pain exercise programs is to determine if trunk control can be changed by core stabilization exercises. The proposed mechanism of pain reduction and functional improvement of core stabilization exercises is that it enhances trunk movement and muscle control. This study will provide preliminary evidence of the link between patient outcomes and treatment mechanisms.

The investigators hypothesize that:

  • both treatment groups will demonstrate significant improvements in pain and function;
  • only subjects in the core stabilization group will demonstrate significant improvements in trunk movement and muscle control.
Registry
clinicaltrials.gov
Start Date
May 2011
End Date
March 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sheri Silfies

Principal Investigator

Drexel University

Eligibility Criteria

Inclusion Criteria

  • duration of the current episode less than 3 months,
  • average pain intensity over past 2 weeks greater than 4 on an 11 point (0 = no pain, 10 = worst pain ever) verbal pain rating scale,
  • self-report global function less than 80% (0-100 %, 100% = normal pain free function)
  • Oswestry Index \> 19%
  • no physical therapy or chiropractic treatment for the current episode of low back pain.
  • clinical diagnosis of poor trunk control/ clinical lumbar instability needs to be met based upon completion of specific physical therapy examination finding

Exclusion Criteria

  • permanent structural spinal deformity (e.g., scoliosis),
  • spinal fracture or history of spinal fracture,
  • osteoporosis,
  • inflammatory joint disease,
  • signs of systemic illness or suspected non-mechanical LBP (spinal tumor or infection),
  • previous spinal surgery,
  • frank neurological loss, i.e., weakness and sensory loss in a NR distribution,
  • pain or paresthesia below the knee,
  • leg length discrepancy of greater than 2.5 cm,
  • history of neurologic disease that required hospitalization,

Outcomes

Primary Outcomes

Trunk Neuromuscular Control

Time Frame: Baseline, 8 weeks

Using surface EMG, kinematics and force parameters. Trunk neuromuscular control is characterized and compared between groups and pre/post intervention.

Secondary Outcomes

  • Clinical Outcomes(Baseline, 8-weeks)

Study Sites (2)

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