Low Back PainNCT01381224
Do Lower Spine Injections Improve Outcomes for Lower Back Pain Patients
An observational study of Low Back Pain, run by University of Florida at 2 sites in United States.
Trial summary
The purpose of this project is to determine the effect of lower back injections on select biomechanical outcomes, walking patterns, lower back flexibility and balance. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Observation of biomechanical effects post injection
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Oct 2012
- 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 receiving a lumbar epidural steroid injection for lumbar spine stenosis
Who may be able to join
- diagnosis of lumbar spine stenosis
- receiving lumbar epidural injection
- age 18-90 years
- BMI <35kg/m2
- walking unaided
Who cannot join
- age <18 or >90 years
- BMI >35 kg/m2
- severely impaired intellectual capacity
- medications that could impact balance
- dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shands Rehabilitation Hospital
Gainesville, Florida, 32607
UF&Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
About this study
Official title: Do Lumbar Spine Injections Improve Short-Term Biomechanical Outcomes in Patients With Chronic Low Back Pain
The purpose of this project is to determine the effect of lower back injections on select biomechanical outcomes, walking patterns, lower back flexibility and balance.
Read the detailed description
The purpose of this project is to determine the effect of lumbar injections on select biomechanics parameters; walking pattern, lumbar flexibility and balance. The surveys will help assess the patient's sense of functional ability and feeling of wellness compared with low back pain scores. The long terms goals of this project will be to elucidate the mechanism of action of injections and to improve identification of patients that are likely to benefit from injection therapy
- Conditions
- Low Back Pain
- Being tested
- Observation of biomechanical effects post injection
- Keywords
- low back pain, lumbar, injection, lumbar pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of biomechanical effects post injectionOther
Observation of effects on gait, lumbar spine range of motion and pain symptoms immediately following injection and at two weeks post injection
| Study group | Role | What they receive |
|---|---|---|
| Observation of biomechanical effects post injection | Observation of effects on gait, lumbar spine range of motion and pain symptoms immediately following injection and at two weeks post injection. Receives: Other: Observation of biomechanical effects post injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the immediate biomechanical effect in patients that receive a lumbar epidural injection
We hypothesize that patients will demonstrate increased gait velocity, increased step length, decreased asymmetry and increased lumbar ROM immediately after injection compared to pre-injection
Measured: Immediately following injection
Secondary outcomes (2)
Determine the short-term biomechanical effect in patients that receive a lumbar epidural injection
We hypothesize that patients will demonstrate increased gait velocity, increased step length, decreased asymmetry and increased lumbar ROM 2 weeks after injection compared with pre- and post-injection time points
Measured: Two weeks following injection
Determine the relationship between biomechanical status before injection and short-term pain reduction
We hypothesize that those patients with moderate biomechanical limitation before injection (e.g., higher gait velocity, higher step length, lower asymmetry, and greater lumbar ROM) will have greater positive biomechanical response than patients who demonstrate severe biomechanical limitation pre-injection. This response to the injection will be measured by the changes in gait and lumbar spine range of motion and pain symptoms with these activities at 2 weeks after the injection
Measured: Two weeks following injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryan P Conrad, Ph.D., Principal investigator, UF Department of Orthopaedics and RehabilitationD J Kennedy, M.D., Principal investigator, UF Department of Orthopaedics and RehabilitationHeather K Vincent, Ph.D., Principal investigator, UF Department of Orthopaedics and RehabilitationDeepa Sunkari, M.D., Principal investigator, UF Department of Orthopaedics and RehabilitationAmanda N Seay, B.S., Principal investigator, UF Department of Orthopaedics and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381224
- Sponsor's protocol ID
- 629-2010
- Status last verified
- Apr 2013
- First submitted
- 22 Jun 2011
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Lumbar Spine Injections Improve Short-Term Biomechanical Outcomes in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01381224
- Acronym / sponsor ID
- 629-2010
- Conditions
- Low Back Pain
- Keywords
- low back pain, lumbar, injection, lumbar pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Jun 2011 (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 project is to determine the effect of lower back injections on select biomechanical outcomes, walking patterns, lower back flexibility and balance.
Detailed description
The purpose of this project is to determine the effect of lumbar injections on select biomechanics parameters; walking pattern, lumbar flexibility and balance. The surveys will help assess the patient's sense of functional ability and feeling of wellness compared with low back pain scores. The long terms goals of this project will be to elucidate the mechanism of action of injections and to improve identification of patients that are likely to benefit from injection therapy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation of biomechanical effects post injection | – | Other: Observation of biomechanical effects post injectionObservation of effects on gait, lumbar spine range of motion and pain symptoms immediately following injection and at two weeks post injection. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving a lumbar epidural steroid injection for lumbar spine stenosis
Key inclusion criteria (5 listed)
- diagnosis of lumbar spine stenosis
- receiving lumbar epidural injection
- age 18-90 years
- BMI <35kg/m2
- walking unaided
Key exclusion criteria (5 listed)
- age <18 or >90 years
- BMI >35 kg/m2
- severely impaired intellectual capacity
- medications that could impact balance
- dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol
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 |
|---|---|---|
| Observation of biomechanical effects post injectionObservation of effects on gait, lumbar spine range of motion and pain symptoms immediately following injection and at two weeks post injection | Other | Observation of biomechanical effects post injection |
Primary outcome
Determine the immediate biomechanical effect in patients that receive a lumbar epidural injection
Time frame: Immediately following injection
We hypothesize that patients will demonstrate increased gait velocity, increased step length, decreased asymmetry and increased lumbar ROM immediately after injection compared to pre-injection
2 secondary outcomes
Determine the short-term biomechanical effect in patients that receive a lumbar epidural injection
Time frame: Two weeks following injection
Determine the relationship between biomechanical status before injection and short-term pain reduction
Time frame: Two weeks following injection
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 22 Apr 2013.
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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.
Bryan P Conrad, Ph.D. principal investigator
UF Department of Orthopaedics and Rehabilitation
D J Kennedy, M.D. principal investigator
UF Department of Orthopaedics and Rehabilitation
Heather K Vincent, Ph.D. principal investigator
UF Department of Orthopaedics and Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by University of Florida at 2 sites 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 5 inclusion and 5 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 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Determine the immediate biomechanical effect in patients that receive a lumbar epidural injection (time frame: Immediately following injection). 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 22 Apr 2013.