Low Back Pain in Obese Patients After Important Weight LossSPINOBNCT04893954
Prospective Study on the Consequences of Weight Loss After Bariatric Surgery on Obese Patients' Spine.
A study testing Full Spine Radiography and Lumbar spine MRI in people with Low Back Pain in Obese Patients After Important Weight Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain in Obese Patients After Important Weight Loss
- What is being tested?
- Full Spine Radiography and Lumbar spine MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2021to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of spine surgery
- Bariatric surgery postoperative complication
- Non mastering of french language
- MRI contraindication
- Patient under legal protection ( e.g. guardianship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Européen Georges Pompidou
Paris, 75015
Emmanuelle FERRERO, MD, PHD, 00 33 1 56 09 32 50, emmanuelle.ferrero@aphp.fr
About this study
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.
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 .
Read the 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).
- Being tested
- Full Spine Radiography, Lumbar spine MRI
- Keywords
- Bariatric, Spine, Obese, Low back pain, Sagittal alignment, Lipomatosis
- Medical subject headings
- Obesity, Low Back Pain, Lipomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Spine RadiographyDiagnostic test
Full Spine Radiography
Lumbar spine MRIDiagnostic test
Lumbar spine MRI
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | Other | Not described Receives: Diagnostic Test: Full Spine Radiography; Diagnostic Test: Lumbar spine MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability Index (ODI)
Clinical score to evaluate low back pain vs Preoperative evaluation
Measured: 1 year postoperative
Oswestry disability Index (ODI)
Clinical score to evaluate low back pain vs Preoperative evaluation
Measured: 2 years postoperative
Secondary outcomes (22)
Oswestry disability Index (ODI)
Clinical score to evaluate low back pain vs Preoperative evaluation
Measured: 6 months postoperative
Sagittal alignment
Radiologic measurement of spine parameters vs Preoperative evaluation
Measured: 6 months postoperative
Sagittal alignment
Radiologic measurement of spine parameters vs Preoperative evaluation
Measured: 1 year postoperative
Sagittal alignment
Radiologic measurement of spine parameters vs Preoperative evaluation
Measured: 2 years postoperative
Disc degeneration
MRI evaluation vs Preoperative evaluation
Measured: 6 months postoperative
Disc degeneration
MRI evaluation vs Preoperative evaluation
Measured: 1 year postoperative
Disc degeneration
MRI evaluation vs Preoperative evaluation
Measured: 2 years postoperative
Lipomatosis
MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Measured: 6 months postoperative
Lipomatosis
MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Measured: 1 year postoperative
Lipomatosis
MRI evaluation of lumbar epidural fat accumulation vs Preoperative evaluation
Measured: 2 years postoperative
Visual Analog Scale (VAS)
Clinical score to evaluate low back pain vs Preoperative evaluation
Measured: 6 months postoperative
Visual Analog Scale (VAS)
Clinical score to evaluate low back pain vs Preoperative evaluation
Measured: 1 year postoperative
Visual Analog Scale (VAS)
Clinical score to evaluate low back pain vs Preoperative evaluation
Measured: 2 years postoperative
Neck disability Index (NDI)
clinical score to evaluate neck pain vs Preoperative evaluation
Measured: 6 months postoperative
Neck disability Index (NDI)
clinical score to evaluate neck pain vs Preoperative evaluation
Measured: 1 year postoperative
Neck disability Index (NDI)
clinical score to evaluate neck pain vs Preoperative evaluation
Measured: 2 years postoperative
Short Form 12 (SF12)
Score to evaluate quality of life vs Preoperative evaluation
Measured: 6 months postoperative
Short Form 12 (SF12)
Score to evaluate quality of life vs Preoperative evaluation
Measured: 1 year postoperative
Short Form 12 (SF12)
Score to evaluate quality of life vs Preoperative evaluation
Measured: 2 years postoperative
Hospital anxiety and depression (HAD) scale
Score to evaluate depression vs Preoperative evaluation
Measured: 6 months postoperative
Hospital anxiety and depression (HAD) scale
Score to evaluate depression vs Preoperative evaluation
Measured: 1 year postoperative
Hospital anxiety and depression (HAD) scale
Score to evaluate depression vs Preoperative evaluation
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start3 Jun 2021
- Primary completionJul 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain in Obese Patients After Important Weight LossStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Sauver La Vie, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Emmanuelle FERRERO, MD, PHD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893954
- Sponsor's protocol ID
- APHP201602
- Acronym
- SPINOB
- Status last verified
- Sep 2025
- First submitted
- 24 Feb 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23187041Khoueir 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.
PubMed 19356988Koulischer 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.
PubMed 26372975de 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.
PubMed 30877387Beckworth 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.
PubMed 30202377Joaquim 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.
PubMed 32002354
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04893954
- Acronym / sponsor ID
- SPINOB / APHP201602
- Keywords
- Bariatric, Spine, Obese, Low back pain, Sagittal alignment, Lipomatosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Sauver La Vie, URC-CIC Paris Descartes Necker Cochin
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients | Other | Diagnostic Test: Full Spine Radiography, Diagnostic Test: Lumbar spine MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- History of spine surgery
- Bariatric surgery postoperative complication
- Non mastering of french language
- MRI contraindication
- Patient under legal protection ( e.g. guardianship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Spine RadiographyFull Spine Radiography | Diagnostic test | Obese patients |
| Lumbar spine MRILumbar spine MRI | Diagnostic test | Obese patients |
Primary outcome
Oswestry disability Index (ODI)
Time frame: 1 year postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
Oswestry disability Index (ODI)
Time frame: 2 years postoperative
Clinical score to evaluate low back pain vs Preoperative evaluation
22 secondary outcomes
Oswestry disability Index (ODI)
Time frame: 6 months postoperative
Sagittal alignment
Time frame: 6 months postoperative
Sagittal alignment
Time frame: 1 year postoperative
Sagittal alignment
Time frame: 2 years postoperative
Disc degeneration
Time frame: 6 months postoperative
Disc degeneration
Time frame: 1 year postoperative
Disc degeneration
Time frame: 2 years postoperative
Lipomatosis
Time frame: 6 months postoperative
Lipomatosis
Time frame: 1 year postoperative
Lipomatosis
Time frame: 2 years postoperative
Visual Analog Scale (VAS)
Time frame: 6 months postoperative
Visual Analog Scale (VAS)
Time frame: 1 year postoperative
Visual Analog Scale (VAS)
Time frame: 2 years postoperative
Neck disability Index (NDI)
Time frame: 6 months postoperative
Neck disability Index (NDI)
Time frame: 1 year postoperative
Neck disability Index (NDI)
Time frame: 2 years postoperative
Short Form 12 (SF12)
Time frame: 6 months postoperative
Short Form 12 (SF12)
Time frame: 1 year postoperative
Short Form 12 (SF12)
Time frame: 2 years postoperative
Hospital anxiety and depression (HAD) scale
Time frame: 6 months postoperative
Hospital anxiety and depression (HAD) scale
Time frame: 1 year postoperative
Hospital anxiety and depression (HAD) scale
Time frame: 2 years postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 23187041Briggs 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.
- Background: PubMed 19356988Khoueir 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.
- Background: PubMed 26372975Koulischer 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.
- Background: PubMed 30877387de 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.
- Background: PubMed 30202377Beckworth 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.
- Background: PubMed 32002354Joaquim 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emmanuelle FERRERO, MD, PHD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Spine Radiography and Lumbar spine MRI in people with Low Back Pain in Obese Patients After Important Weight Loss, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle FERRERO, MD, PHD (01 56 09 32 50, emmanuelle.ferrero@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry disability Index (ODI) (time frame: 1 year postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04893954, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.