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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00306423
Other study ID # #025027
Secondary ID
Status Completed
Phase Phase 1
First received March 21, 2006
Last updated March 30, 2017
Start date June 2003
Est. completion date August 2014

Study information

Verified date March 2017
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Exercise


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 2014
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Southern California Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary ODI pre and post intervention
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