NCT00306423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

8.2 years

First QC Date

March 21, 2006

Last Update Submit

March 30, 2017

Conditions

Low Back Disorder

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

  • ODI

    pre and post intervention

Interventions

Other: ExercisePROCEDURE

exercise 3 times per week for 12 weeks

Also known as: exercise 3 times per week for 12 weeks

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Single level lumbar microdiscectomy

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kornelia Kulig, PhD, PT

    University of Southern California

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 23, 2006

Study Start

June 1, 2003

Primary Completion

August 1, 2011

Study Completion

August 1, 2014

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

US(1)