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Clinical Trials/NCT00894972
NCT00894972
Completed
Not Applicable

Examining the Effectiveness of a Post-operative Rehabilitation Program Emphasizing Restoration of Multifidus Muscle Function for Individuals Undergoing Lumbar Discectomy: a Randomized Clinical Trial

University of Utah1 site in 1 country60 target enrollmentApril 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Disc Herniation
Sponsor
University of Utah
Enrollment
60
Locations
1
Primary Endpoint
Modified Oswestry disability index
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The proposed study will be a randomized clinical trial designed to determine the most effective physical therapy program for individuals who have undergone lumbar discectomy surgery. The study will compare two different post-operative physical therapy programs (general strengthening or general + specific strengthening). Both groups will begin treatment 2 weeks post-surgery. Subjects in both groups will receive weekly treatment sessions for 8 weeks with a treatment program emphasizing exercises shown to activate the large trunk muscles without imposing potentially harmful compression or shear forces. The general + specific strengthening group will also receive exercises shown to isolate activation of the deep trunk muscles, in particular the multifidus, with training augmented by the use of diagnostic ultrasound biofeedback. Patient assessments will be conducted pre- and post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
April 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie Fritz

Associate Professor

University of Utah

Eligibility Criteria

Inclusion Criteria

  • 18-60 years old
  • Diagnosis of LDH based on imaging (MRI or CT scan) of the lumbar spine with concurring clinical examination findings (based on the judgment of the attending neurosurgeon)
  • Appropriate surgical candidate based on the opinion of the attending spine surgeon, and scheduled for single-level lumbar discectomy (open or micro-discectomy).
  • Able to attend weekly treatment sessions.

Exclusion Criteria

  • Prior surgery to the lumbar spine
  • Spondylolytic or degenerative spondylolisthesis present on pre-surgical imaging
  • Unable to speak and understand English
  • Peri- or post-operative complication (infection, nerve injury, dural tear, vascular injury, etc.) that would limit or delay the ability to participate in post-operative rehabilitation.
  • Multi-level surgery or the use of instrumentation during surgery (i.e., lumbar fusion)

Outcomes

Primary Outcomes

Modified Oswestry disability index

Time Frame: Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months

Secondary Outcomes

  • Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging(preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months)

Study Sites (1)

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