Lumbar Intervertebral Disc HerniationNCT01041391
Lumbar Disc Herniation Outcome Measures
An observational study of Lumbar Intervertebral Disc Herniation, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
This study is being conducted to examine outcome measurements on patients who undergo surgery to removed a damage lumbar spine disc versus those that chose not to have surgery. These outcomes are based on patient responses to quality of life and pain questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lumbar Intervertebral Disc Herniation
- What is being tested?
- Discectomy-lumbar spine
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to 13 Jan 2013
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the SUNY Upstate Orthopedic Surgery department
Who may be able to join
- Must be at least 18 years of age and no older than 90 years of age
- Must have diagnosis of Lumbar disc herniation
- Must be able to understand English, and willing to consent to data collection
- Must be a current patient in our practice
Who cannot join
- Prisoner
- Unable to complete questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University-Department of Orthopedics
Syracuse, New York, 13202
About this study
Official title: Lumbar Disc Herniation Outcome Measures-Surgical Versus Non-Operative Treatment
This study is being conducted to examine outcome measurements on patients who undergo surgery to removed a damage lumbar spine disc versus those that chose not to have surgery. These outcomes are based on patient responses to quality of life and pain questionnaires.
Read the detailed description
Lumbar discectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to non-operative care remains controversial.
Several studies have compared surgical and non-operative treatment of patients with herniated discs, but baseline differences between treatment groups, small sample sizes, or lack of validated outcome measures in these studies limit evident-based conclusions regarding optimal treatment.
There is increasing emphasis on the use of health-related quality of life(QOL)outcome measures to determine the efficacy of treatment, particularly for diseases that are not life threatening but affect the patient's QOL. In the treatment of lumbar disc herniation, the Medical Outcomes Study Short Form (SF-36), Oswestry Disability Index (ODI) and Visual Analog Scale (VAS), are validated and common scales that are used to measure treatment outcomes.
Information is routinely collected on activity limitations in the course of the doctor's assessment of the patient, however, the data may not always be collected in a standardized format that yields measurement with known reliability and validity. Standardized self-report questionnaires provide a convenient method of collecting and synthesizing a large amount of information on the pain, activity limitation and general health status of each patient.
The objective of this prospective study is to evaluate the efficacy of surgery for lumbar intervertebral disc herniations using the SF-36, ODI and VAS as primary outcome measures. Patients experiencing acute or chronic lumbar spine pain in the Orthopedic practice will be given a choice to participate in this study. On patient's who wish to participate, the data will be collected and entered into the REMARK OMR 7 database, and evaluated for outcomes.
This study is for current patients in the Upstate Orthopedic office.
- Conditions
- Lumbar Intervertebral Disc Herniation
- Being tested
- Discectomy-lumbar spine
- Keywords
- Surgical intervention vs Non-Surgical intervention
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discectomy-lumbar spineProcedure or surgery
Lumbar intervertebral discectomy performed on patients with herniated disc that chose to have surgical intervention
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment for Lumbar disc herniation | Patients who had or will have surgery for Lumbar disc herniation Receives: Procedure: Discectomy-lumbar spine | |
| Non-surgical treatment for Lumbar disc herniation | Patients that have chosen conservative treatment for lumbar disc herniation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of surgery for lumbar intervertebral disc herniation vs non-operative treatment, using self-report questionnaires Short form 36, Visual Analog Scale and Oswestry Disability Index at baseline (prior to surgery) and all subsequent visits
data will be collected at each office visit, regardless of time point
Measured: baseline (prior to surgery) & 12 mos post op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startMay 2009
- Primary completion13 Jan 2013
- Study completion13 Jan 2013
Why it stopped: Slow/low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Intervertebral Disc HerniationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Lavelle, State University of New York - Upstate Medical University
- Investigators
- William F. Lavelle, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041391
- Sponsor's protocol ID
- 5812-LSS
- Status last verified
- Sep 2018
- First submitted
- 18 Nov 2009
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Disc Herniation Outcome Measures-Surgical Versus Non-Operative Treatment
- ClinicalTrials.gov ID
- NCT01041391
- Acronym / sponsor ID
- 5812-LSS
- Conditions
- Lumbar Intervertebral Disc Herniation
- Keywords
- Surgical intervention vs Non-Surgical intervention
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow/low enrollment
- Enrolment
- 35 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- 13 Jan 2013 (actual)
- Study completion
- 13 Jan 2013 (actual)
- First posted
- 31 Dec 2009 (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.
This study is being conducted to examine outcome measurements on patients who undergo surgery to removed a damage lumbar spine disc versus those that chose not to have surgery. These outcomes are based on patient responses to quality of life and pain questionnaires.
Detailed description
Lumbar discectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to non-operative care remains controversial.
Several studies have compared surgical and non-operative treatment of patients with herniated discs, but baseline differences between treatment groups, small sample sizes, or lack of validated outcome measures in these studies limit evident-based conclusions regarding optimal treatment.
There is increasing emphasis on the use of health-related quality of life(QOL)outcome measures to determine the efficacy of treatment, particularly for diseases that are not life threatening but affect the patient's QOL. In the treatment of lumbar disc herniation, the Medical Outcomes Study Short Form (SF-36), Oswestry Disability Index (ODI) and Visual Analog Scale (VAS), are validated and common scales that are used to measure treatment outcomes.
Information is routinely collected on activity limitations in the course of the doctor's assessment of the patient, however, the data may not always be collected in a standardized format that yields measurement with known reliability and validity. Standardized self-report questionnaires provide a convenient method of collecting and synthesizing a large amount of information on the pain, activity limitation and general health status of each patient.
The objective of this prospective study is to evaluate the efficacy of surgery for lumbar intervertebral disc herniations using the SF-36, ODI and VAS as primary outcome measures. Patients experiencing acute or chronic lumbar spine pain in the Orthopedic practice will be given a choice to participate in this study. On patient's who wish to participate, the data will be collected and entered into the REMARK OMR 7 database, and evaluated for outcomes.
This study is for current patients in the Upstate Orthopedic office.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment for Lumbar disc herniation | – | Procedure: Discectomy-lumbar spinePatients who had or will have surgery for Lumbar disc herniation |
| Non-surgical treatment for Lumbar disc herniation | – | –Patients that have chosen conservative treatment for lumbar disc herniation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the SUNY Upstate Orthopedic Surgery department
Key inclusion criteria (4 listed)
- Must be at least 18 years of age and no older than 90 years of age
- Must have diagnosis of Lumbar disc herniation
- Must be able to understand English, and willing to consent to data collection
- Must be a current patient in our practice
Key exclusion criteria (2 listed)
- Prisoner
- Unable to complete questionnaires
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 |
|---|---|---|
| Discectomy-lumbar spineLumbar intervertebral discectomy performed on patients with herniated disc that chose to have surgical intervention | Procedure or surgery | Surgical treatment for Lumbar disc herniation |
Primary outcome
The efficacy of surgery for lumbar intervertebral disc herniation vs non-operative treatment, using self-report questionnaires Short form 36, Visual Analog Scale and Oswestry Disability Index at baseline (prior to surgery) and all subsequent visits
Time frame: baseline (prior to surgery) & 12 mos post op.
data will be collected at each office visit, regardless of time point
Results and safety
The study was stopped early (reason given: Slow/low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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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.
William F. Lavelle, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Intervertebral Disc Herniation, run by State University of New York - Upstate Medical University 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Sep 2018. 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.
Are results available for this study?
The study was stopped early (reason given: Slow/low enrollment). Results are not available in the source record.
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?
The efficacy of surgery for lumbar intervertebral disc herniation vs non-operative treatment, using self-report questionnaires Short form 36, Visual Analog Scale and Oswestry Disability Index at baseline (prior to surgery) and all subsequent visits (time frame: baseline (prior to surgery) & 12 mos post op.). 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 6 Sep 2018.