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Rehabilitation Post Lumbar Microdiscectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kornelia Kulig, University of Southern California
ClinicalTrials.gov Identifier:
NCT00306423
First received: March 21, 2006
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Low Back Disorder
 Procedure: Other: Exercise
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • ODI [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2003
Estimated Study Completion Date: September 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Other: Exercise
    exercise 3 times per week for 12 weeks
    Other Name: exercise 3 times per week for 12 weeks
Detailed Description:

Exercise

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Kornelia Kulig, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00306423     History of Changes
Other Study ID Numbers: #025027
Study First Received: March 21, 2006
Last Updated: June 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
exercise

ClinicalTrials.gov processed this record on May 23, 2013