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

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain in Obese Patients After Important Weight Loss
• Intervention / Treatment: Diagnostic test: Full Spine Radiography; Diagnostic test: Lumbar spine MRI

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie BENHAMMANI-GODARD; Phone Number: 00 33 1 58 41 11 90; Email: marie.godard@aphp.fr
• Study Contact Backup: Name: Emmanuelle FERRERO, MD, PHD; Phone Number: 00 33 1 56 09 32 50; Email: emmanuelle.ferrero@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Hopital Europeen Georges Pompidou
    • Contact: Emmanuelle FERRERO, MD, PHD; Phone Number: 00 33 1 56 09 32 50; Email: emmanuelle.ferrero@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Obese patients	Diagnostic test: Full Spine Radiography; Full Spine Radiography; Diagnostic test: Lumbar spine MRI; Lumbar spine MRI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Sauver La Vie
• Investigators: Principal Investigator: Emmanuelle FERRERO, MD, PHD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Low back pain; Obese; Bariatric; Spine; Sagittal alignment; Lipomatosis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Body Weight Changes; Back Pain; Low Back Pain; Weight Loss; Body Weight
• Other Study ID Numbers: APHP201602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No