Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine.

Study Overview
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Brief Summary
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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 .

Detailed Description
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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).

Official Title
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Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine : Effects on Low Back Pain, Sagittal Alignment and Lipomatosis.

Conditions
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Low Back Pain in Obese Patients After Important Weight Loss

Intervention / Treatment
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* Diagnostic Test: Full Spine Radiography
* Diagnostic Test: Lumbar spine MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old 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: History of spine surgery Bariatric surgery postoperative complication Non mastering of french language MRI contraindication Patient under legal protection ( e.g. guardianship)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Obese patients<br> | Diagnostic Test: Full Spine Radiography<br>* Full Spine Radiography<br>Diagnostic Test: Lumbar spine MRI<br>* Lumbar spine MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric, Spine, Obese, Low back pain, Sagittal alignment, Lipomatosis