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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04893954
Acronym
SPINOB
Enrollment
80
Registered
2021-05-20
Start date
2021-06-03
Completion date
2029-09-30
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain in Obese Patients After Important Weight Loss

Keywords

Bariatric, Spine, Obese, Low back pain, Sagittal alignment, Lipomatosis

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).

Interventions

DIAGNOSTIC_TESTFull Spine Radiography

Full Spine Radiography

DIAGNOSTIC_TESTLumbar spine MRI

Lumbar spine MRI

Sponsors

Sauver La Vie
CollaboratorUNKNOWN
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Oswestry disability Index (ODI)1 year postoperativeClinical score to evaluate low back pain vs Preoperative evaluation

Secondary

MeasureTime frameDescription
Sagittal alignment6 months postoperativeRadiologic measurement of spine parameters vs Preoperative evaluation
Disc degeneration6 months postoperativeMRI evaluation vs Preoperative evaluation
Lipomatosis6 months postoperativeMRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Oswestry disability Index (ODI)6 months postoperativeClinical score to evaluate low back pain vs Preoperative evaluation
Neck disability Index (NDI)6 months postoperativeclinical score to evaluate neck pain vs Preoperative evaluation
Short Form 12 (SF12)6 months postoperativeScore to evaluate quality of life vs Preoperative evaluation
Hospital anxiety and depression (HAD) scale6 months postoperativeScore to evaluate depression vs Preoperative evaluation
Visual Analog Scale (VAS)6 months postoperativeClinical score to evaluate low back pain vs Preoperative evaluation

Countries

France

Contacts

Primary ContactEmmanuelle FERRERO, MD, PHD
emmanuelle.ferrero@aphp.fr01 56 09 32 50
Backup ContactMarie BENHAMMANI-GODARD
marie.godard@aphp.fr00 33 1 58 41 11 90

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026