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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University of Utah:

Primary Outcome Measures:
  • Modified Oswestry disability index [ Time Frame: Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Julie Fritz, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00894972     History of Changes
Other Study ID Numbers: 32474
Study First Received: May 5, 2009
Last Updated: November 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Intervertebral Disc Displacement
Radiculopathy
Bone Diseases
Hernia
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathological Conditions, Anatomical
Peripheral Nervous System Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on November 23, 2014