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| Name | Class |
|---|---|
| Sauver La Vie | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to determine how an important weight loss after bariatric surgery affects obese patients ' spine, and the effects it has on low back pain, sagittal alignment and lipomatosis .
Obesity and back pain are massive public health problems, and the relationship between the two has not been described and studied. However, the investigators have also observed that many ex-obese patients still suffer from back and leg pain after an important weight loss.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese patients | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Spine Radiography | Diagnostic Test | Full Spine Radiography |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry disability Index (ODI) | Clinical score to evaluate low back pain vs Preoperative evaluation | 1 year postoperative |
| Oswestry disability Index (ODI) | Clinical score to evaluate low back pain vs Preoperative evaluation | 2 years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry disability Index (ODI) | Clinical score to evaluate low back pain vs Preoperative evaluation | 6 months postoperative |
| Sagittal alignment | Radiologic measurement of spine parameters vs Preoperative evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanuelle FERRERO, MD, PHD | Contact | 01 56 09 32 50 | emmanuelle.ferrero@aphp.fr | |
| Marie BENHAMMANI-GODARD | Contact | 00 33 1 58 41 11 90 | marie.godard@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuelle FERRERO, MD, PHD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Européen Georges Pompidou | Recruiting | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23187041 | Background | 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. | |
| 19356988 | Background | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D017116 | Low Back Pain |
| D008068 | Lipomatosis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Lumbar spine MRI |
| Diagnostic Test |
Lumbar spine MRI |
|
| 6 months postoperative |
| Sagittal alignment | Radiologic measurement of spine parameters vs Preoperative evaluation | 1 year postoperative |
| Sagittal alignment | Radiologic measurement of spine parameters vs Preoperative evaluation | 2 years postoperative |
| Disc degeneration | MRI evaluation vs Preoperative evaluation | 6 months postoperative |
| Disc degeneration | MRI evaluation vs Preoperative evaluation | 1 year postoperative |
| Disc degeneration | MRI evaluation vs Preoperative evaluation | 2 years postoperative |
| Lipomatosis | MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation | 6 months postoperative |
| Lipomatosis | MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation | 1 year postoperative |
| Lipomatosis | MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation | 2 years postoperative |
| Visual Analog Scale (VAS) | Clinical score to evaluate low back pain vs Preoperative evaluation | 6 months postoperative |
| Visual Analog Scale (VAS) | Clinical score to evaluate low back pain vs Preoperative evaluation | 1 year postoperative |
| Visual Analog Scale (VAS) | Clinical score to evaluate low back pain vs Preoperative evaluation | 2 years postoperative |
| Neck disability Index (NDI) | clinical score to evaluate neck pain vs Preoperative evaluation | 6 months postoperative |
| Neck disability Index (NDI) | clinical score to evaluate neck pain vs Preoperative evaluation | 1 year postoperative |
| Neck disability Index (NDI) | clinical score to evaluate neck pain vs Preoperative evaluation | 2 years postoperative |
| Short Form 12 (SF12) | Score to evaluate quality of life vs Preoperative evaluation | 6 months postoperative |
| Short Form 12 (SF12) | Score to evaluate quality of life vs Preoperative evaluation | 1 year postoperative |
| Short Form 12 (SF12) | Score to evaluate quality of life vs Preoperative evaluation | 2 years postoperative |
| Hospital anxiety and depression (HAD) scale | Score to evaluate depression vs Preoperative evaluation | 6 months postoperative |
| Hospital anxiety and depression (HAD) scale | Score to evaluate depression vs Preoperative evaluation | 1 year postoperative |
| Hospital anxiety and depression (HAD) scale | Score to evaluate depression vs Preoperative evaluation | 2 years postoperative |
| 26372975 | Background | 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. |
| 30877387 | Background | 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. |
| 30202377 | Background | 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. |
| 32002354 | Background | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |