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NCT Number: NCT04893954

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

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 .

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Full Spine Radiography

Diagnostic Test

Full Spine Radiography

Lumbar spine MRI

Diagnostic Test

Lumbar spine MRI

Primary outcomes

  1. Oswestry disability Index (ODI)

    Time frame: 1 year postoperative

    Clinical score to evaluate low back pain vs Preoperative evaluation

  2. Oswestry disability Index (ODI)

    Time frame: 2 years postoperative

    Clinical score to evaluate low back pain vs Preoperative evaluation

Secondary outcomes

  1. Oswestry disability Index (ODI)

    Time frame: 6 months postoperative

    Clinical score to evaluate low back pain vs Preoperative evaluation

  2. Sagittal alignment

    Time frame: 6 months postoperative

    Radiologic measurement of spine parameters vs Preoperative evaluation

  3. Sagittal alignment

    Time frame: 1 year postoperative

    Radiologic measurement of spine parameters vs Preoperative evaluation

  4. Sagittal alignment

    Time frame: 2 years postoperative

    Radiologic measurement of spine parameters vs Preoperative evaluation

  5. Disc degeneration

    Time frame: 6 months postoperative

    MRI evaluation vs Preoperative evaluation

  6. Disc degeneration

    Time frame: 1 year postoperative

    MRI evaluation vs Preoperative evaluation

  7. Disc degeneration

    Time frame: 2 years postoperative

    MRI evaluation vs Preoperative evaluation

  8. Lipomatosis

    Time frame: 6 months postoperative

    MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation

  9. Lipomatosis

    Time frame: 1 year postoperative

    MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation

  10. Lipomatosis

    Time frame: 2 years postoperative

    MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation

  11. Visual Analog Scale (VAS)

    Time frame: 6 months postoperative

    Clinical score to evaluate low back pain vs Preoperative evaluation

  12. Visual Analog Scale (VAS)

    Time frame: 1 year postoperative

    Clinical score to evaluate low back pain vs Preoperative evaluation

  13. Visual Analog Scale (VAS)

    Time frame: 2 years postoperative

    Clinical score to evaluate low back pain vs Preoperative evaluation

  14. Neck disability Index (NDI)

    Time frame: 6 months postoperative

    clinical score to evaluate neck pain vs Preoperative evaluation

  15. Neck disability Index (NDI)

    Time frame: 1 year postoperative

    clinical score to evaluate neck pain vs Preoperative evaluation

  16. Neck disability Index (NDI)

    Time frame: 2 years postoperative

    clinical score to evaluate neck pain vs Preoperative evaluation

  17. Short Form 12 (SF12)

    Time frame: 6 months postoperative

    Score to evaluate quality of life vs Preoperative evaluation

  18. Short Form 12 (SF12)

    Time frame: 1 year postoperative

    Score to evaluate quality of life vs Preoperative evaluation

  19. Short Form 12 (SF12)

    Time frame: 2 years postoperative

    Score to evaluate quality of life vs Preoperative evaluation

  20. Hospital anxiety and depression (HAD) scale

    Time frame: 6 months postoperative

    Score to evaluate depression vs Preoperative evaluation

  21. Hospital anxiety and depression (HAD) scale

    Time frame: 1 year postoperative

    Score to evaluate depression vs Preoperative evaluation

  22. Hospital anxiety and depression (HAD) scale

    Time frame: 2 years postoperative

    Score to evaluate depression vs Preoperative evaluation

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuelle FERRERO, MD, PHD

CONTACT

[email protected]

01 56 09 32 50

Marie BENHAMMANI-GODARD

CONTACT

[email protected]

00 33 1 58 41 11 90

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Sauver La Vie
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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.

Acronym: SPINOB

Important dates

Study start
2021
Primary completion
2027
Study completion
2029
First posted
May 20, 2021
Registry last updated
Sep 15, 2025

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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