Spinal StenosisNCT04622501
Spinal Epidural Lipomatosis: a Case Report and Review of the Literature
An observational study of Spinal Stenosis, run by Canadian Memorial Chiropractic College at 1 site in Canada.
Trial summary
Introduction Lumbar spinal epidural lipomatosis (SEL) is a rare condition defined by an excessive deposition of adipose tissue in the lumbar spinal canal. The objective of this case report is to document a clinical case of SEL presenting within a multidisciplinary spine clinic and to compare our clinical findings and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- posterior spinal decompression and posterior spinal instrumented fusion
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2019to 10 Jun 2020
- 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 100 years
- All sexes
- Adult, Older adult
Study population: Patients consulting in a multidisciplinary spine clinic
Who may be able to join
- Adults patient with a clinical diagnosis of Spinal Epidural Lipomatosis (MRI and clinical diagnosis)
Who cannot join
- Absence of clinical diagnosis of Spinal Epidural Lipomatosis
Trial locations and contacts
1 site in 1 country.
About this study
Introduction Lumbar spinal epidural lipomatosis (SEL) is a rare condition defined by an excessive deposition of adipose tissue in the lumbar spinal canal. The objective of this case report is to document a clinical case of SEL presenting within a multidisciplinary spine clinic and to compare our clinical findings and management with the current literature.
Case presentation A 51-year-old female presented at a spine clinic with low back pain, bilateral leg pain and difficulty walking. MR imaging of the lumbar spine showed L4-L5 and L5-S1 degenerative disk disease with evidence of severe central canal stenosis due to extensive epidural lipomatosis. The patient was initially advised to lose weight, undergo a course of physiotherapy, and consult with the pain clinic. Because of lack of improvement, the patient was scheduled for L4-S1 posterior spinal decompression and L4-L5 posterior spinal instrumented fusion.
Read more
Discussion The discussion will include the diagnosis of SEL, imaging appearance, its risk factors, etiology and management.
Conclusion This case report describes a case of lumbar spinal stenosis due to SEL with neurological symptoms. Some risk factors have also been identified in the literature. MRI is considered as the reference standard for its diagnosis. The therapeutic approach of patients with SEL is not standardized. Thus, reporting and investigating the diagnostic process and treatment of this patient will positively contribute to better management for other future patients.
- Conditions
- Spinal Stenosis
- Being tested
- posterior spinal decompression and posterior spinal instrumented fusion
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior spinal decompression and posterior spinal instrumented fusionProcedure or surgery
posterior spinal decompression and posterior spinal instrumented fusion performed on a patient with Spinal Epidural Lipomatosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain
Visual Pain Scale (0-10)
Measured: 3 months before surgery
Low back pain
Visual Pain Scale (0-10)
Measured: 6 weeks after surgery
Distance Walking
Distance walking (meter)
Measured: 3 months before surgery
Distance Walking
Distance walking (meter)
Measured: 6 weeks after surgery
Low back pain
Visual Pain Scale (0-10)
Measured: 3 months after surgery
Low back pain
Visual Pain Scale (0-10)
Measured: 1 year after surgery
Distance walking
Distance walking (meter)
Measured: 3 months after surgery
Distance walking
Distance walking (meter)
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start10 Jun 2019
- Primary completion11 Jun 2019
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Memorial Chiropractic College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622501
- Sponsor's protocol ID
- 202015
- Status last verified
- Nov 2020
- First submitted
- 10 Aug 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Borre DG, Borre GE, Aude F, Palmieri GN. Lumbosacral epidural lipomatosis: MRI grading. Eur Radiol. 2003 Jul;13(7):1709-21. doi: 10.1007/s00330-002-1716-4. Epub 2002 Dec 13.
PubMed 12835988Fogel GR, Cunningham PY 3rd, Esses SI. Spinal epidural lipomatosis: case reports, literature review and meta-analysis. Spine J. 2005 Mar-Apr;5(2):202-11. doi: 10.1016/j.spinee.2004.05.252.
PubMed 15795966Agha RA, Borrelli MR, Farwana R, Koshy K, Fowler AJ, Orgill DP; SCARE Group. The SCARE 2018 statement: Updating consensus Surgical CAse REport (SCARE) guidelines. Int J Surg. 2018 Dec;60:132-136. doi: 10.1016/j.ijsu.2018.10.028. Epub 2018 Oct 18.
PubMed 30342279Fassett DR, Schmidt MH. Spinal epidural lipomatosis: a review of its causes and recommendations for treatment. Neurosurg Focus. 2004 Apr 15;16(4):E11.
PubMed 15191340Theyskens NC, Paulino Pereira NR, Janssen SJ, Bono CM, Schwab JH, Cha TD. The prevalence of spinal epidural lipomatosis on magnetic resonance imaging. Spine J. 2017 Jul;17(7):969-976. doi: 10.1016/j.spinee.2017.02.010. Epub 2017 Mar 3.
PubMed 28263890Yildirim B, Puvanesarajah V, An HS, Novicoff WM, Jain A, Shen FH, Hassanzadeh H. Lumbosacral Epidural Lipomatosis: A Retrospective Matched Case-Control Database Study. World Neurosurg. 2016 Dec;96:209-214. doi: 10.1016/j.wneu.2016.08.125. Epub 2016 Sep 5.
PubMed 27609448Kim K, Mendelis J, Cho W. Spinal Epidural Lipomatosis: A Review of Pathogenesis, Characteristics, Clinical Presentation, and Management. Global Spine J. 2019 Sep;9(6):658-665. doi: 10.1177/2192568218793617. Epub 2018 Aug 13.
PubMed 31448201Malone JB, Bevan PJ, Lewis TJ, Nelson AD, Blaty DE, Kahan ME. Incidence of spinal epidural lipomatosis in patients with spinal stenosis. J Orthop. 2017 Nov 6;15(1):36-39. doi: 10.1016/j.jor.2017.11.001. eCollection 2018 Mar.
PubMed 29203971Walchli B, Benini A. Spinal epidural lipomatosis. Swiss Med Wkly. 2001 Jun 16;131(23-24):359. doi: 10.4414/smw.2001.09739. No abstract available.
PubMed 11486570Ferlic PW, Mannion AF, Jeszenszky D, Porchet F, Fekete TF, Kleinstuck F, Haschtmann D. Patient-reported outcome of surgical treatment for lumbar spinal epidural lipomatosis. Spine J. 2016 Nov;16(11):1333-1341. doi: 10.1016/j.spinee.2016.06.022. Epub 2016 Jun 27.
PubMed 27363757
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Epidural Lipomatosis: a Case Report and Review of the Literature
- ClinicalTrials.gov ID
- NCT04622501
- Acronym / sponsor ID
- 202015
- Conditions
- Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Canadian Memorial Chiropractic CollegeUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 10 Nov 2020 (actual)
- 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.
Introduction Lumbar spinal epidural lipomatosis (SEL) is a rare condition defined by an excessive deposition of adipose tissue in the lumbar spinal canal. The objective of this case report is to document a clinical case of SEL presenting within a multidisciplinary spine clinic and to compare our clinical findings and management with the current literature.
Case presentation A 51-year-old female presented at a spine clinic with low back pain, bilateral leg pain and difficulty walking. MR imaging of the lumbar spine showed L4-L5 and L5-S1 degenerative disk disease with evidence of severe central canal stenosis due to extensive epidural lipomatosis. The patient was initially advised to lose weight, undergo a course of physiotherapy, and consult with the pain clinic. Because of lack of improvement, the patient was scheduled for L4-S1 posterior spinal decompression and L4-L5 posterior spinal instrumented fusion.
Discussion The discussion will include the diagnosis of SEL, imaging appearance, its risk factors, etiology and management.
Conclusion This case report describes a case of lumbar spinal stenosis due to SEL with neurological symptoms. Some risk factors have also been identified in the literature. MRI is considered as the reference standard for its diagnosis. The therapeutic approach of patients with SEL is not standardized. Thus, reporting and investigating the diagnostic process and treatment of this patient will positively contribute to better management for other future patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients consulting in a multidisciplinary spine clinic
Key inclusion criteria (1 listed)
- Adults patient with a clinical diagnosis of Spinal Epidural Lipomatosis (MRI and clinical diagnosis)
Key exclusion criteria (1 listed)
- Absence of clinical diagnosis of Spinal Epidural Lipomatosis
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 |
|---|---|---|
| posterior spinal decompression and posterior spinal instrumented fusionposterior spinal decompression and posterior spinal instrumented fusion performed on a patient with Spinal Epidural Lipomatosis | Procedure or surgery | – |
Primary outcome
Low back pain
Time frame: 3 months before surgery
Visual Pain Scale (0-10)
Low back pain
Time frame: 6 weeks after surgery
Visual Pain Scale (0-10)
Distance Walking
Time frame: 3 months before surgery
Distance walking (meter)
Distance Walking
Time frame: 6 weeks after surgery
Distance walking (meter)
Low back pain
Time frame: 3 months after surgery
Visual Pain Scale (0-10)
Low back pain
Time frame: 1 year after surgery
Visual Pain Scale (0-10)
Distance walking
Time frame: 3 months after surgery
Distance walking (meter)
Distance walking
Time frame: 1 year after surgery
Distance walking (meter)
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 12 Nov 2020.
- Background: PubMed 12835988Borre DG, Borre GE, Aude F, Palmieri GN. Lumbosacral epidural lipomatosis: MRI grading. Eur Radiol. 2003 Jul;13(7):1709-21. doi: 10.1007/s00330-002-1716-4. Epub 2002 Dec 13.
- Background: PubMed 15795966Fogel GR, Cunningham PY 3rd, Esses SI. Spinal epidural lipomatosis: case reports, literature review and meta-analysis. Spine J. 2005 Mar-Apr;5(2):202-11. doi: 10.1016/j.spinee.2004.05.252.
- Background: PubMed 30342279Agha RA, Borrelli MR, Farwana R, Koshy K, Fowler AJ, Orgill DP; SCARE Group. The SCARE 2018 statement: Updating consensus Surgical CAse REport (SCARE) guidelines. Int J Surg. 2018 Dec;60:132-136. doi: 10.1016/j.ijsu.2018.10.028. Epub 2018 Oct 18.
- Background: PubMed 15191340Fassett DR, Schmidt MH. Spinal epidural lipomatosis: a review of its causes and recommendations for treatment. Neurosurg Focus. 2004 Apr 15;16(4):E11.
- Background: PubMed 28263890Theyskens NC, Paulino Pereira NR, Janssen SJ, Bono CM, Schwab JH, Cha TD. The prevalence of spinal epidural lipomatosis on magnetic resonance imaging. Spine J. 2017 Jul;17(7):969-976. doi: 10.1016/j.spinee.2017.02.010. Epub 2017 Mar 3.
- Background: PubMed 27609448Yildirim B, Puvanesarajah V, An HS, Novicoff WM, Jain A, Shen FH, Hassanzadeh H. Lumbosacral Epidural Lipomatosis: A Retrospective Matched Case-Control Database Study. World Neurosurg. 2016 Dec;96:209-214. doi: 10.1016/j.wneu.2016.08.125. Epub 2016 Sep 5.
- Background: PubMed 31448201Kim K, Mendelis J, Cho W. Spinal Epidural Lipomatosis: A Review of Pathogenesis, Characteristics, Clinical Presentation, and Management. Global Spine J. 2019 Sep;9(6):658-665. doi: 10.1177/2192568218793617. Epub 2018 Aug 13.
- Background: PubMed 29203971Malone JB, Bevan PJ, Lewis TJ, Nelson AD, Blaty DE, Kahan ME. Incidence of spinal epidural lipomatosis in patients with spinal stenosis. J Orthop. 2017 Nov 6;15(1):36-39. doi: 10.1016/j.jor.2017.11.001. eCollection 2018 Mar.
- Background: PubMed 11486570Walchli B, Benini A. Spinal epidural lipomatosis. Swiss Med Wkly. 2001 Jun 16;131(23-24):359. doi: 10.4414/smw.2001.09739. No abstract available.
- Background: PubMed 27363757Ferlic PW, Mannion AF, Jeszenszky D, Porchet F, Fekete TF, Kleinstuck F, Haschtmann D. Patient-reported outcome of surgical treatment for lumbar spinal epidural lipomatosis. Spine J. 2016 Nov;16(11):1333-1341. doi: 10.1016/j.spinee.2016.06.022. Epub 2016 Jun 27.
- Individual participant dataSharing planned: Undecided
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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.
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 Spinal Stenosis, run by Canadian Memorial Chiropractic College at 1 site in Canada.
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 1 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: finished, as of the sponsor's last update on 12 Nov 2020. 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 Canada. 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?
Low back pain (time frame: 3 months before surgery). The study lists 8 primary outcomes in all. 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 NCT04622501, which also lists 10 linked publications.
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 12 Nov 2020.