Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine.
NCT ID: NCT04893954
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2021-06-03
2029-09-30
Brief Summary
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Detailed Description
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The aim of this study is to measure the effect of weight loss on back pain, and to find out what parameters can explain such modifications (increasing or decreasing back pain).
The investigators will study clinical parameters, as well as radiological (to measure the effect of weight loss on spine sagittal alignment) and MRI (to measure lipomatosis, which is a fat epidural accumulation, responsible for nerve compression and therefore back and leg pain).
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Obese patients
Full Spine Radiography
Full Spine Radiography
Lumbar spine MRI
Lumbar spine MRI
Interventions
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Full Spine Radiography
Full Spine Radiography
Lumbar spine MRI
Lumbar spine MRI
Eligibility Criteria
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Inclusion Criteria
* BMI \> 40 or BMI \> 35 with comorbidities due to obesity ( criteria for bariatric surgery)
* Follow up in Pompidou's Hospital Nutrition service
* Bariatric surgery intervention ( Sleeve gastrectomy or By pass)
* Follow up possible for one year or more
* Being covered by French social insurance
* Consent to participate in the study
Exclusion Criteria
* Bariatric surgery postoperative complication
* Non mastering of french language
* MRI contraindication
* Patient under legal protection ( e.g. guardianship)
18 Years
ALL
No
Sponsors
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Sauver La Vie
UNKNOWN
URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Emmanuelle FERRERO, MD, PHD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hopital Européen Georges Pompidou
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Briggs MS, Givens DL, Schmitt LC, Taylor CA. Relations of C-reactive protein and obesity to the prevalence and the odds of reporting low back pain. Arch Phys Med Rehabil. 2013 Apr;94(4):745-52. doi: 10.1016/j.apmr.2012.11.026. Epub 2012 Nov 24.
Khoueir P, Black MH, Crookes PF, Kaufman HS, Katkhouda N, Wang MY. Prospective assessment of axial back pain symptoms before and after bariatric weight reduction surgery. Spine J. 2009 Jun;9(6):454-63. doi: 10.1016/j.spinee.2009.02.003. Epub 2009 Apr 8.
Koulischer S, Cadiere B, Cadiere GB, Fabeck L. [Evolution of low back pain after bariatric surgery]. Rev Med Brux. 2015 May-Jun;36(3):147-51. French.
de Mello AP, Martins GCDS, Heringer AR, Gamallo RB, Martins Filho LFDS, de Abreu AV, Carvalho ACP, Gama MP. Back pain and sagittal spine alignment in obese patients eligible for bariatric surgery. Eur Spine J. 2019 May;28(5):967-975. doi: 10.1007/s00586-019-05935-0. Epub 2019 Mar 15.
Beckworth WJ, McCarty EJ, Garcia-Corrada JE, Holbrook JF. Epidural Lipomatosis and Associated Spinal Stenosis-The Impact of Weight Loss: A Case Report. Am J Lifestyle Med. 2017 Jan 12;11(6):511-514. doi: 10.1177/1559827616686764. eCollection 2017 Nov-Dec.
Joaquim AF, Helvie P, Patel AA. Bariatric Surgery and Low Back Pain: A Systematic Literature Review. Global Spine J. 2020 Feb;10(1):102-110. doi: 10.1177/2192568219826935. Epub 2019 Feb 5.
Other Identifiers
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APHP201602
Identifier Type: -
Identifier Source: org_study_id
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