Clinical trial NCT04893954: Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine.
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
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain in Obese Patients After Important Weight Loss
Keywords: Bariatric
Spine
Obese
Low back pain
Sagittal alignment
Lipomatosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Sauver La Vie
First posted: 2021-05-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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)

Primary outcomes:
measure: Oswestry disability Index (ODI)
timeFrame: 1 year postoperative
measure: Oswestry disability Index (ODI)
timeFrame: 2 years postoperative
Secondary outcomes:
measure: Oswestry disability Index (ODI)
timeFrame: 6 months postoperative
measure: Sagittal alignment
timeFrame: 6 months postoperative
measure: Sagittal alignment
timeFrame: 1 year postoperative
measure: Sagittal alignment
timeFrame: 2 years postoperative
measure: Disc degeneration
timeFrame: 6 months postoperative
measure: Disc degeneration
timeFrame: 1 year postoperative
measure: Disc degeneration
timeFrame: 2 years postoperative
measure: Lipomatosis
timeFrame: 6 months postoperative
measure: Lipomatosis
timeFrame: 1 year postoperative
measure: Lipomatosis
timeFrame: 2 years postoperative
measure: Visual Analog Scale (VAS)
timeFrame: 6 months postoperative
measure: Visual Analog Scale (VAS)
timeFrame: 1 year postoperative
measure: Visual Analog Scale (VAS)
timeFrame: 2 years postoperative
measure: Neck disability Index (NDI)
timeFrame: 6 months postoperative
measure: Neck disability Index (NDI)
timeFrame: 1 year postoperative
measure: Neck disability Index (NDI)
timeFrame: 2 years postoperative
measure: Short Form 12 (SF12)
timeFrame: 6 months postoperative
measure: Short Form 12 (SF12)
timeFrame: 1 year postoperative
measure: Short Form 12 (SF12)
timeFrame: 2 years postoperative
measure: Hospital anxiety and depression (HAD) scale
timeFrame: 6 months postoperative
measure: Hospital anxiety and depression (HAD) scale
timeFrame: 1 year postoperative
measure: Hospital anxiety and depression (HAD) scale
timeFrame: 2 years postoperative
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Européen Georges Pompidou
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Emmanuelle FERRERO, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.