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

Primary Purpose

Low Back Pain in Obese Patients After Important Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Full Spine Radiography
Lumbar spine MRI
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Back Pain in Obese Patients After Important Weight Loss focused on measuring Bariatric, Spine, Obese, Low back pain, Sagittal alignment, Lipomatosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hopital Européen Georges PompidouRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Obese patients

Arm Description

Outcomes

Primary Outcome Measures

Oswestry disability Index (ODI)
Clinical score to evaluate low back pain vs Preoperative evaluation
Oswestry disability Index (ODI)
Clinical score to evaluate low back pain vs Preoperative evaluation

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2021
Last Updated
January 19, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Sauver La Vie
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1. Study Identification

Unique Protocol Identification Number
NCT04893954
Brief Title
Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine.
Acronym
SPINOB
Official Title
Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine : Effects on Low Back Pain, Sagittal Alignment and Lipomatosis.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Sauver La Vie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain in Obese Patients After Important Weight Loss
Keywords
Bariatric, Spine, Obese, Low back pain, Sagittal alignment, Lipomatosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Obese patients
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Full Spine Radiography
Intervention Description
Full Spine Radiography
Intervention Type
Diagnostic Test
Intervention Name(s)
Lumbar spine MRI
Intervention Description
Lumbar spine MRI
Primary Outcome Measure Information:
Title
Oswestry disability Index (ODI)
Description
Clinical score to evaluate low back pain vs Preoperative evaluation
Time Frame
1 year postoperative
Title
Oswestry disability Index (ODI)
Description
Clinical score to evaluate low back pain vs Preoperative evaluation
Time Frame
2 years postoperative
Secondary Outcome Measure Information:
Title
Oswestry disability Index (ODI)
Description
Clinical score to evaluate low back pain vs Preoperative evaluation
Time Frame
6 months postoperative
Title
Sagittal alignment
Description
Radiologic measurement of spine parameters vs Preoperative evaluation
Time Frame
6 months postoperative
Title
Sagittal alignment
Description
Radiologic measurement of spine parameters vs Preoperative evaluation
Time Frame
1 year postoperative
Title
Sagittal alignment
Description
Radiologic measurement of spine parameters vs Preoperative evaluation
Time Frame
2 years postoperative
Title
Disc degeneration
Description
MRI evaluation vs Preoperative evaluation
Time Frame
6 months postoperative
Title
Disc degeneration
Description
MRI evaluation vs Preoperative evaluation
Time Frame
1 year postoperative
Title
Disc degeneration
Description
MRI evaluation vs Preoperative evaluation
Time Frame
2 years postoperative
Title
Lipomatosis
Description
MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Time Frame
6 months postoperative
Title
Lipomatosis
Description
MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Time Frame
1 year postoperative
Title
Lipomatosis
Description
MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Time Frame
2 years postoperative
Title
Visual Analog Scale (VAS)
Description
Clinical score to evaluate low back pain vs Preoperative evaluation
Time Frame
6 months postoperative
Title
Visual Analog Scale (VAS)
Description
Clinical score to evaluate low back pain vs Preoperative evaluation
Time Frame
1 year postoperative
Title
Visual Analog Scale (VAS)
Description
Clinical score to evaluate low back pain vs Preoperative evaluation
Time Frame
2 years postoperative
Title
Neck disability Index (NDI)
Description
clinical score to evaluate neck pain vs Preoperative evaluation
Time Frame
6 months postoperative
Title
Neck disability Index (NDI)
Description
clinical score to evaluate neck pain vs Preoperative evaluation
Time Frame
1 year postoperative
Title
Neck disability Index (NDI)
Description
clinical score to evaluate neck pain vs Preoperative evaluation
Time Frame
2 years postoperative
Title
Short Form 12 (SF12)
Description
Score to evaluate quality of life vs Preoperative evaluation
Time Frame
6 months postoperative
Title
Short Form 12 (SF12)
Description
Score to evaluate quality of life vs Preoperative evaluation
Time Frame
1 year postoperative
Title
Short Form 12 (SF12)
Description
Score to evaluate quality of life vs Preoperative evaluation
Time Frame
2 years postoperative
Title
Hospital anxiety and depression (HAD) scale
Description
Score to evaluate depression vs Preoperative evaluation
Time Frame
6 months postoperative
Title
Hospital anxiety and depression (HAD) scale
Description
Score to evaluate depression vs Preoperative evaluation
Time Frame
1 year postoperative
Title
Hospital anxiety and depression (HAD) scale
Description
Score to evaluate depression vs Preoperative evaluation
Time Frame
2 years postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuelle FERRERO, MD, PHD
Phone
00 33 1 56 09 32 50
Email
emmanuelle.ferrero@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie BENHAMMANI-GODARD
Phone
00 33 1 58 41 11 90
Email
marie.godard@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle FERRERO, MD, PHD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle FERRERO, MD, PHD
Phone
00 33 1 56 09 32 50
Email
emmanuelle.ferrero@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23187041
Citation
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.
Results Reference
background
PubMed Identifier
19356988
Citation
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.
Results Reference
background
PubMed Identifier
26372975
Citation
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.
Results Reference
background
PubMed Identifier
30877387
Citation
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.
Results Reference
background
PubMed Identifier
30202377
Citation
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.
Results Reference
background
PubMed Identifier
32002354
Citation
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.
Results Reference
background

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

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