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Rehabilitation Following Lumbar Disc Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Fritz, University of Utah
ClinicalTrials.gov Identifier:
NCT00894972
First received: May 5, 2009
Last updated: November 5, 2012
Last verified: November 2012
History of Changes

May 5, 2009
November 5, 2012
April 2009
April 2012   (final data collection date for primary outcome measure)
Modified Oswestry disability index [ Time Frame: Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00894972 on ClinicalTrials.gov Archive Site
Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging [ Time Frame: preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rehabilitation Following Lumbar Disc Surgery
Examining the Effectiveness of a Post-operative Rehabilitation Program Emphasizing Restoration of Multifidus Muscle Function for Individuals Undergoing Lumbar Discectomy: a Randomized Clinical Trial

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Lumbar Disc Herniation
  • Radiculopathy
Other: Rehabilitation following lumbar disc surgery (discectomy)
Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.
  • Active Comparator: 1
    General exercise. Participants in this group will perform aerobic exercise, range of motion exercise and general strengthening exercise.
    Intervention: Other: Rehabilitation following lumbar disc surgery (discectomy)
  • Experimental: 2
    Specific exercise. Participants in this group will perform aerobic exercise, range of motion exercise, and specific motor control exercises.
    Intervention: Other: Rehabilitation following lumbar disc surgery (discectomy)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2012
April 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00894972
32474
No
Julie Fritz, University of Utah
University of Utah
Not Provided
Principal Investigator: Julie Fritz, PT, PhD, ATC University of Utah
University of Utah
November 2012

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