Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine : Effects on Low Back Pain, Sagittal Alignment and Lipomatosis.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Oswestry disability Index (ODI)
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Oswestry disability Index (ODI)
Time Frame: 2 years postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
Secondary Outcomes
- Sagittal alignment(2 years postoperative)
- Visual Analog Scale (VAS)(2 years postoperative)
- Short Form 12 (SF12)(2 years postoperative)
- Disc degeneration(2 years postoperative)
- Lipomatosis(2 years postoperative)
- Hospital anxiety and depression (HAD) scale(2 years postoperative)
- Oswestry disability Index (ODI)(6 months postoperative)
- Neck disability Index (NDI)(2 years postoperative)