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Rehabilitation Post Lumbar Microdiscectomy

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ClinicalTrials.gov Identifier: NCT00306423
Recruitment Status : Completed
First Posted : March 23, 2006
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Kornelia Kulig, University of Southern California

Brief Summary:
The purpose of this study is to determine whether a rehabilitation program following lumbar microdiscectomy influences short-term (4 months) and long-term (up to 5 years)outcomes in quality of life, activity and endurance.

Condition or disease Intervention/treatment Phase
Low Back Disorder Procedure: Other: Exercise Phase 1

Detailed Description:
Exercise

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : June 2003
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Other: Exercise
    exercise 3 times per week for 12 weeks
    Other Name: exercise 3 times per week for 12 weeks


Primary Outcome Measures :
  1. ODI [ Time Frame: pre and post intervention ]


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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
  • Single level lumbar microdiscectomy

Exclusion Criteria:

  • Potential subjects will be excluded is they exhibit symptoms suggestive of facet arthrosis or neurogenic claudication, or if their plain radiographs showed more than 50 percent loss of disc height at the relevant level.
  • Patients in whom the protrusion occupied more than 50 percent of the sagittal diameter of the spinal canal or in whom sequestrated fragments were seen on MRI will also be excluded.

Other exclusion criteria will include:

  • Previous back surgeries
  • Presence of any other concurrent foot pathology besides leg and low back pain and associated single level disc injury
  • Nervous system problems (e.g., stroke, dementia, seizures)
  • Cognitive dysfunction (e.g. TBI, CVA, Alzheimer's)
  • Uncontrolled cardiovascular disease
  • Evidence of cord compression
  • Uncontrolled hypertension
  • Infection
  • Severe respiratory disease
  • Pregnancy
  • Rheumatic joint disease
  • Peripheral vascular disease with sensory loss of the foot
  • Any condition that the subject identifies that might limit participation in physical activity

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): NCT00306423


Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
Investigators
Study Director: Kornelia Kulig, PhD, PT University of Southern California

Responsible Party: Kornelia Kulig, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00306423     History of Changes
Other Study ID Numbers: #025027
First Posted: March 23, 2006    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Kornelia Kulig, University of Southern California:
exercise