Lumbar Spinal StenosisNCT02103543
Comparison of the Order of Treatment in Lumbar Spinal Stenosis
A study testing physical therapy, lumbar interlaminar epidural steroid injection and epidural steroid injection in people with Lumbar Spinal Stenosis, run by Emory University at 1 site in United States.
Trial summary
Patients with back pain with spinal stenosis of the lower back will be asked to volunteer for this research study. These patients don't need immediate surgery for this problem. Treatment of this kind of back pain with spinal stenosis usually includes physical therapy exercises and steroid injections. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- physical therapy, lumbar interlaminar epidural steroid injection and epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- history of lumbar surgery, acute disc herniation as reported on a radiologic imaging report, acute or severe chronic illness that are unstable, cognitive impairment which prevents the patient from providing accurate data or giving informed consent, neurological conditions (e.g. stroke, Parkinson's, brain injury), lower extremity amputees, fibromyalgia or chronic generalized pain, unstable opioid use or any signs or evidence of alcohol dependence or illicit drug use (as determined by screening questionnaire), clinical suspicion of facet joint-originating back pain or a positive response to prior facet joint block, lumbar epidural steroid injections within the last 6 months, uncontrolled psychiatric disorders, serious concomitant medical illness (e.g. acute heart failure, acute renal failure) or severe pain that may impair patient's ability to participate in physical therapy exercises or pain that is deemed so severe such that withholding of an ESI until after completion of the PT exercises is seen as causing unreasonable suffering to the patient, and conditions that would prevent the patient from undergoing fluoroscopy (e.g. pregnancy).
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta Veterans Affairs Medical Center
Decatur, Georgia, 30033
About this study
Official title: A Randomized Trial in Patients With Lumbar Spinal Stenosis, Comparing the Order of Treatment With Epidural Corticosteroid Injections and Physical Therapy
Patients with back pain with spinal stenosis of the lower back will be asked to volunteer for this research study. These patients don't need immediate surgery for this problem. Treatment of this kind of back pain with spinal stenosis usually includes physical therapy exercises and steroid injections. Both treatments are usually helpful in patients with back pain with spinal stenosis. However, physicians and other healthcare providers don't know which treatment is better to give first. The purpose of this research is to answer that question. Patients enrolled in this study will receive both treatments: physical therapy (PT) and a steroid injection ("shot"). However, patients may get the shot first followed by PT, or they may have PT first, followed by the shot. Their time in this study will last up to 6 months, and there will be five outcome measurements (via visits or telephone). All study visits will take place at the Atlanta VA Medical Center (Atlanta VA). Investigators hope to enroll about 120 subjects from the Atlanta VA. Enrolled patients will be randomized using a randomization computer program.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- physical therapy, lumbar interlaminar epidural steroid injection, epidural steroid injection
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapyOther
physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions
lumbar interlaminar epidural steroid injectionProcedure or surgery
single lumbar interlaminar epidural steroid injection
epidural steroid injectionDrug
Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy first | Active comparator | patients will undergo physical therapy 3-4 sessions followed by lumbar interlaminar epidural steroid injection Receives: Other: physical therapy; Procedure: lumbar interlaminar epidural steroid injection; Drug: epidural steroid injection |
| lumbar epidural steroid first | Active comparator | lumbar interlaminar epidural steroid injection followed by patients will undergo physical therapy 3-4 sessions Receives: Other: physical therapy; Procedure: lumbar interlaminar epidural steroid injection; Drug: epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability Index
measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year
Measured: 1 year
Secondary outcomes (1)
visual analog scale
measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startJan 2014 (estimated)
- Primary completionJan 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Monfared MD, Emory University
- Investigators
- Hassan Monfared, MD, Study director, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103543
- Sponsor's protocol ID
- IRB00061868
- Status last verified
- Feb 2017
- First submitted
- 27 Mar 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial in Patients With Lumbar Spinal Stenosis, Comparing the Order of Treatment With Epidural Corticosteroid Injections and Physical Therapy
- ClinicalTrials.gov ID
- NCT02103543
- Acronym / sponsor ID
- IRB00061868
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2014 (estimated)
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Apr 2014 (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.
Patients with back pain with spinal stenosis of the lower back will be asked to volunteer for this research study. These patients don't need immediate surgery for this problem. Treatment of this kind of back pain with spinal stenosis usually includes physical therapy exercises and steroid injections. Both treatments are usually helpful in patients with back pain with spinal stenosis. However, physicians and other healthcare providers don't know which treatment is better to give first. The purpose of this research is to answer that question. Patients enrolled in this study will receive both treatments: physical therapy (PT) and a steroid injection ("shot"). However, patients may get the shot first followed by PT, or they may have PT first, followed by the shot. Their time in this study will last up to 6 months, and there will be five outcome measurements (via visits or telephone). All study visits will take place at the Atlanta VA Medical Center (Atlanta VA). Investigators hope to enroll about 120 subjects from the Atlanta VA. Enrolled patients will be randomized using a randomization computer program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy first | Active comparator | Other: physical therapy, Procedure: lumbar interlaminar epidural steroid injection, Drug: epidural steroid injectionpatients will undergo physical therapy 3-4 sessions followed by lumbar interlaminar epidural steroid injection |
| lumbar epidural steroid first | Active comparator | Other: physical therapy, Procedure: lumbar interlaminar epidural steroid injection, Drug: epidural steroid injectionlumbar interlaminar epidural steroid injection followed by patients will undergo physical therapy 3-4 sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- history of lumbar surgery, acute disc herniation as reported on a radiologic imaging report, acute or severe chronic illness that are unstable, cognitive impairment which prevents the patient from providing accurate data or giving informed consent, neurological conditions (e.g. stroke, Parkinson's, brain injury), lower extremity amputees, fibromyalgia or chronic generalized pain, unstable opioid use or any signs or evidence of alcohol dependence or illicit drug use (as determined by screening questionnaire), clinical suspicion of facet joint-originating back pain or a positive response to prior facet joint block, lumbar epidural steroid injections within the last 6 months, uncontrolled psychiatric disorders, serious concomitant medical illness (e.g. acute heart failure, acute renal failure) or severe pain that may impair patient's ability to participate in physical therapy exercises or pain that is deemed so severe such that withholding of an ESI until after completion of the PT exercises is seen as causing unreasonable suffering to the patient, and conditions that would prevent the patient from undergoing fluoroscopy (e.g. pregnancy).
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 |
|---|---|---|
| physical therapyphysical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions | Other | Physical Therapy first, lumbar epidural steroid first |
| lumbar interlaminar epidural steroid injectionsingle lumbar interlaminar epidural steroid injection | Procedure or surgery | Physical Therapy first, lumbar epidural steroid first |
| epidural steroid injectionDexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume) | Drug | Physical Therapy first, lumbar epidural steroid first |
Primary outcome
Oswestry disability Index
Time frame: 1 year
measurements will be done at baseline, week 4 (1-2 weeks after intervention), 6 months, and at 1 year
1 secondary outcome
visual analog scale
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
Related trials for Lumbar Spinal Stenosis
Not yet recruitingObservational study
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Surgical Treatment of Adjacent Segment Stenosis
Adjacent Segment Disease, Lumbar Spinal Stenosis
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.
Hassan Monfared, MD study director
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy, lumbar interlaminar epidural steroid injection and epidural steroid injection in people with Lumbar Spinal Stenosis, run by Emory 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 0 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 Feb 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Oswestry disability Index (time frame: 1 year). 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 23 Feb 2017.