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

Not Applicable

Recruiting

• Conditions: Low Back Pain in Obese Patients After Important Weight Loss
• Interventions: Diagnostic Test: Full Spine Radiography; Diagnostic Test: Lumbar spine MRI

• Registration Number: NCT04893954
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-05-14
• Study First Posted: 2021-05-20
• Study Start: 2021-06-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2027-07
• Study Completion: 2029-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Obese patients	Full Spine Radiography	-
Obese patients	Lumbar spine MRI	-

Primary Outcome Measures

Name	Time	Method
Oswestry disability Index (ODI)	2 years postoperative	Clinical score to evaluate low back pain vs Preoperative evaluation

Secondary Outcome Measures

Name	Time	Method
Sagittal alignment	2 years postoperative	Radiologic measurement of spine parameters vs Preoperative evaluation
Visual Analog Scale (VAS)	2 years postoperative	Clinical score to evaluate low back pain vs Preoperative evaluation
Short Form 12 (SF12)	2 years postoperative	Score to evaluate quality of life vs Preoperative evaluation
Disc degeneration	2 years postoperative	MRI evaluation vs Preoperative evaluation
Lipomatosis	2 years postoperative	MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Hospital anxiety and depression (HAD) scale	2 years postoperative	Score to evaluate depression vs Preoperative evaluation
Oswestry disability Index (ODI)	6 months postoperative	Clinical score to evaluate low back pain vs Preoperative evaluation
Neck disability Index (NDI)	2 years postoperative	clinical score to evaluate neck pain vs Preoperative evaluation

Trial Locations

Locations (1)

Hopital Européen Georges Pompidou; 🇫🇷 Paris, France