Low Back DisorderPhase 1NCT00306423
Rehabilitation Post Lumbar Microdiscectomy
A Phase 1 study testing Other: Exercise in people with Low Back Disorder, run by University of Southern California at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Disorder
- What is being tested?
- Other: Exercise
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old
- Single level lumbar microdiscectomy
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
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.
Read the detailed description
Exercise
- Conditions
- Low Back Disorder
- Being tested
- Other: Exercise
- Keywords
- exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: ExerciseProcedure or surgery
Also called exercise 3 times per week for 12 weeks
exercise 3 times per week for 12 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI
Measured: pre and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startJun 2003
- Primary completionAug 2011
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kornelia Kulig, University of Southern California
- Investigators
- Kornelia Kulig, PhD, PT, Study director, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306423
- Sponsor's protocol ID
- #025027
- Status last verified
- Mar 2017
- First submitted
- 21 Mar 2006
- Last updated
- 4 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Post Lumbar Microdiscectomy
- ClinicalTrials.gov ID
- NCT00306423
- Acronym / sponsor ID
- #025027
- Conditions
- Low Back Disorder
- Keywords
- exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Jun 2003 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Exercise
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-60 years old
- Single level lumbar microdiscectomy
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other: ExerciseAlso: exercise 3 times per week for 12 weeksexercise 3 times per week for 12 weeks | Procedure or surgery | – |
Primary outcome
ODI
Time frame: pre and post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kornelia Kulig, PhD, PT study director
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Other: Exercise in people with Low Back Disorder, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODI (time frame: pre and post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.