Lumbar Spinal StenosisNCT00786981
Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis
A study testing Epidural steroid injection plus physical therapy and Epidural steroid injection in people with Lumbar Spinal Stenosis, run by Franklin Pierce University at 4 sites in United States.
Trial summary
Lumbar spinal stenosis (LSS) is a prevalent and disabling condition in the rapidly growing aging population. People with LSS often have a substantial physical and psychosocial burden as well as significant healthcare costs affecting both the individual and society. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Epidural steroid injection plus physical therapy and Epidural steroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2009to Dec 2018
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lumbar spinal stenosis unidentified by MRI or CT scan and interpreted by a radiologist independent of the study. The criteria of Boden et al will be used to define LSS on MRI: non-discogenic loss of signal in the epidural fat with compression of neural tissues.
- Chief complaint of pain in the low back, buttock, and/or lower extremity. The patient must have LE symptoms consistent with neurogenic claudiation.
- Patient-reported inability to walk greater than ¼ mile due to lower extremity pain and/or cramping.
- Rates sitting as a better position with respect to symptom severity compared to standing or walking.
- Consent of the patient to undergo education, epidural steroid injection(s), and attend specified physical therapy sessions.
- Individuals with no language barrier, that are cooperative, have transportation to the Spine Center, and who sign an informed consent form.
- Age greater than or equal to 50 years.
Who cannot join
- Patients with organic brain syndrome or dementia.
- Severe vascular, pulmonary or coronary artery disease which limits ambulation.
- Recent myocardial infarction (within last 6 months).
- Spondylolisthesis requiring surgical fusion (i.e., greater than 5mm of slippage).
- Previous spinal surgery that included fusion of two or more vertebrae.
- Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.
- Metastatic cancer.
- Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Colorado University
Denver, Colorado
Hawkins Foundation
Greenville, South Carolina, 29615
Keesler Air Force Base
Keesler Air Force Base, Mississippi, 39564
Illinois Neurological Institute at OSF
Peoria, Illinois, 61637
About this study
Official title: Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis; a Randomized Clinical Trial
Lumbar spinal stenosis (LSS) is a prevalent and disabling condition in the rapidly growing aging population. People with LSS often have a substantial physical and psychosocial burden as well as significant healthcare costs affecting both the individual and society. It has been reported that patients with LSS over the age of 65 are more likely to undergo spinal surgery than any other condition with an estimated total annual inpatient expense of one billion. Individuals undergoing surgical treatment for LSS tend to be older, therefore operative morbidity and mortality are a particular concern. Functional benefit derived from conservative treatment may increase the health and quality of life for individuals suffering from LSS and avoid or delay the need for surgery in some subjects. As the population continues to age, identifying effective non-surgical treatment options for older patients with LSS is an important research priority. Ultimately, the information gained from this study will help fill a significant void in medical literature regarding non-surgical options for this patient population.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Epidural steroid injection plus physical therapy, 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.
Epidural steroid injection plus physical therapyOther
Patients in the ESI+PT Group will be treated additionally with a physical therapy program emphasizing lumbar flexion exercises, aerobic and strength/ conditioning exercises, and manual physical therapy as well as receiving up to 3 epidural steroid injection(s) and educational support using The Back Book.
Epidural steroid injectionOther
Patients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Epidural steroid injection and physical therapy | Other | Not described Receives: Other: Epidural steroid injection plus physical therapy |
| Epidural steroid injection | Other | Not described Receives: Other: Epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of interest will be change in disability as measured by the Modified Oswestry Disability Index (OSW).
Measured: 10 weeks, 6 months, 12 months
Secondary outcomes (4)
Change in patient-reported pain
Measured: 10 weeks, 6 months, 12 months
Change in Functional Limitations
Measured: 10 weeks, 6 months, 12 months
Change in psychosocial evaluation
Measured: 10 weeks, 6 months, 12 months
Change in patient satisfaction
Measured: 10 weeks, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startApr 2009
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franklin Pierce University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Joshua Cleland, DPT, OCS, Franklin Pierce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786981
- Sponsor's protocol ID
- FP-36472
- Status last verified
- Jul 2019
- First submitted
- 5 Nov 2008
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hammerich A, Whitman J, Mintken P, Denninger T, Akuthota V, Sawyer EE, Hofmann M, Childs JD, Cleland J. Effectiveness of Physical Therapy Combined With Epidural Steroid Injection for Individuals With Lumbar Spinal Stenosis: A Randomized Parallel-Group Trial. Arch Phys Med Rehabil. 2019 May;100(5):797-810. doi: 10.1016/j.apmr.2018.12.035. Epub 2019 Jan 29.
PubMed 30703349
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00786981
- Acronym / sponsor ID
- FP-36472
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Franklin Pierce UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- Apr 2009
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Nov 2008 (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.
Lumbar spinal stenosis (LSS) is a prevalent and disabling condition in the rapidly growing aging population. People with LSS often have a substantial physical and psychosocial burden as well as significant healthcare costs affecting both the individual and society. It has been reported that patients with LSS over the age of 65 are more likely to undergo spinal surgery than any other condition with an estimated total annual inpatient expense of one billion. Individuals undergoing surgical treatment for LSS tend to be older, therefore operative morbidity and mortality are a particular concern. Functional benefit derived from conservative treatment may increase the health and quality of life for individuals suffering from LSS and avoid or delay the need for surgery in some subjects. As the population continues to age, identifying effective non-surgical treatment options for older patients with LSS is an important research priority. Ultimately, the information gained from this study will help fill a significant void in medical literature regarding non-surgical options for this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural steroid injection and physical therapy | Other | Other: Epidural steroid injection plus physical therapy |
| Epidural steroid injection | Other | Other: Epidural steroid injection |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Lumbar spinal stenosis unidentified by MRI or CT scan and interpreted by a radiologist independent of the study. The criteria of Boden et al will be used to define LSS on MRI: non-discogenic loss of signal in the epidural fat with compression of neural tissues.
- Chief complaint of pain in the low back, buttock, and/or lower extremity. The patient must have LE symptoms consistent with neurogenic claudiation.
- Patient-reported inability to walk greater than ¼ mile due to lower extremity pain and/or cramping.
- Rates sitting as a better position with respect to symptom severity compared to standing or walking.
- Consent of the patient to undergo education, epidural steroid injection(s), and attend specified physical therapy sessions.
Key exclusion criteria (8 listed)
- Patients with organic brain syndrome or dementia.
- Severe vascular, pulmonary or coronary artery disease which limits ambulation.
- Recent myocardial infarction (within last 6 months).
- Spondylolisthesis requiring surgical fusion (i.e., greater than 5mm of slippage).
- Previous spinal surgery that included fusion of two or more vertebrae.
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 |
|---|---|---|
| Epidural steroid injection plus physical therapyPatients in the ESI+PT Group will be treated additionally with a physical therapy program emphasizing lumbar flexion exercises, aerobic and strength/ conditioning exercises, and manual physical therapy as well as receiving up to 3 epidural steroid injection(s) and educational support using The Back Book. | Other | Epidural steroid injection and physical therapy |
| Epidural steroid injectionPatients in the ESI Group will be treated with up to 3 epidural steroid injections, educational support, and general care by the treating physician. | Other | Epidural steroid injection |
Primary outcome
The primary outcome of interest will be change in disability as measured by the Modified Oswestry Disability Index (OSW).
Time frame: 10 weeks, 6 months, 12 months
4 secondary outcomes
Change in patient-reported pain
Time frame: 10 weeks, 6 months, 12 months
Change in Functional Limitations
Time frame: 10 weeks, 6 months, 12 months
Change in psychosocial evaluation
Time frame: 10 weeks, 6 months, 12 months
Change in patient satisfaction
Time frame: 10 weeks, 6 months, 12 months
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 31 Jul 2019.
- Derived from this study: PubMed 30703349Hammerich A, Whitman J, Mintken P, Denninger T, Akuthota V, Sawyer EE, Hofmann M, Childs JD, Cleland J. Effectiveness of Physical Therapy Combined With Epidural Steroid Injection for Individuals With Lumbar Spinal Stenosis: A Randomized Parallel-Group Trial. Arch Phys Med Rehabil. 2019 May;100(5):797-810. doi: 10.1016/j.apmr.2018.12.035. Epub 2019 Jan 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural steroid injection plus physical therapy and Epidural steroid injection in people with Lumbar Spinal Stenosis, run by Franklin Pierce University at 4 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 7 inclusion and 8 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The primary outcome of interest will be change in disability as measured by the Modified Oswestry Disability Index (OSW). (time frame: 10 weeks, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786981, which also lists 1 linked publication.
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 31 Jul 2019.