Hopital Européen Georges Pompidou
Paris, 75015, France
Location status: Recruiting
NCT Number: NCT04893954
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 .
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, 75015, France
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Full Spine Radiography
Lumbar spine MRI
Time frame: 1 year postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
Time frame: 2 years postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
Time frame: 6 months postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
Time frame: 6 months postoperative
Radiologic measurement of spine parameters vs Preoperative evaluation
Time frame: 1 year postoperative
Radiologic measurement of spine parameters vs Preoperative evaluation
Time frame: 2 years postoperative
Radiologic measurement of spine parameters vs Preoperative evaluation
Time frame: 6 months postoperative
MRI evaluation vs Preoperative evaluation
Time frame: 1 year postoperative
MRI evaluation vs Preoperative evaluation
Time frame: 2 years postoperative
MRI evaluation vs Preoperative evaluation
Time frame: 6 months postoperative
MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Time frame: 1 year postoperative
MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Time frame: 2 years postoperative
MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Time frame: 6 months postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
Time frame: 1 year postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
Time frame: 2 years postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
Time frame: 6 months postoperative
clinical score to evaluate neck pain vs Preoperative evaluation
Time frame: 1 year postoperative
clinical score to evaluate neck pain vs Preoperative evaluation
Time frame: 2 years postoperative
clinical score to evaluate neck pain vs Preoperative evaluation
Time frame: 6 months postoperative
Score to evaluate quality of life vs Preoperative evaluation
Time frame: 1 year postoperative
Score to evaluate quality of life vs Preoperative evaluation
Time frame: 2 years postoperative
Score to evaluate quality of life vs Preoperative evaluation
Time frame: 6 months postoperative
Score to evaluate depression vs Preoperative evaluation
Time frame: 1 year postoperative
Score to evaluate depression vs Preoperative evaluation
Time frame: 2 years postoperative
Score to evaluate depression vs Preoperative evaluation
Contact information is provided by the study sponsor or research team.
Emmanuelle FERRERO, MD, PHD
CONTACT
Marie BENHAMMANI-GODARD
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine : Effects on Low Back Pain, Sagittal Alignment and Lipomatosis.
Acronym: SPINOB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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