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Rehabilitation Following Lumbar Disc Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00894972
First Posted: May 7, 2009
Last Update Posted: November 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Julie Fritz, University of Utah
  Purpose
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.

Condition Intervention
Lumbar Disc Herniation Radiculopathy Other: Rehabilitation following lumbar disc surgery (discectomy)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining the Effectiveness of a Post-operative Rehabilitation Program Emphasizing Restoration of Multifidus Muscle Function for Individuals Undergoing Lumbar Discectomy: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Julie Fritz, University of Utah:

Primary Outcome Measures:
  • Modified Oswestry disability index [ Time Frame: Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months ]

Secondary Outcome Measures:
  • Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging [ Time Frame: preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
General exercise. Participants in this group will perform aerobic exercise, range of motion exercise and general strengthening exercise.
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.
Experimental: 2
Specific exercise. Participants in this group will perform aerobic exercise, range of motion exercise, and specific motor control exercises.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894972


Locations
United States, Utah
University of Utah, Department of Physical Therapy
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Julie Fritz, PT, PhD, ATC University of Utah
  More Information

Responsible Party: Julie Fritz, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00894972     History of Changes
Other Study ID Numbers: 32474
First Submitted: May 5, 2009
First Posted: May 7, 2009
Last Update Posted: November 6, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases