Low Back PainNCT05771493
The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patientd Chronic Non-specific Low Back Pain
An observational study of Low Back Pain, run by AZ Nikolaas at 1 site in Belgium.
Trial summary
This pilot study aims at styding the correlations between body mass index, waist circumference and the potential for positional adaptation of the pelvis to support overweight or obesity Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Measurement of baseline characteristics
- How many people
- 272 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2020to 23 Dec 2022
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Adult, Older adult
Study population: 272 patients; 51.8% male, 3.7% underweight; 28.7 % normal weight; 34.2% overweight and 33.5% obees. 50.4% has high WC. Mean PI 57.78
Who may be able to join
- presenting with non-specific low back pain
- having undergone full spine X-ray during the diagnostic proces
Who cannot join
- patients with missing data
- double entry of patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patients With Chronic Non-specific Low Back Pain: an Observational Cross-sectional Correlation Study
This pilot study aims at styding the correlations between body mass index, waist circumference and the potential for positional adaptation of the pelvis to support overweight or obesity
Read the detailed description
Record cards of patients presenting with non specific low back pain between January 1st 2020 and December 23rd 2022 were analysed.
All included patients had undergone a full spine X-ray allowing to calculate the pelvic index (PI). Weight status was described in 4 categories, in-line with the WHO definitions; Underweight (boddy mass index (BMI)) < 18.5 kg/m²; normal weight BMI 18.5 - 24.9 kg/m² , overweight BMI 25 - 29.9 kg/m², and obesity BMI ≥ 30 kg/m². To identify people with increased BMI-values and central (abdominal) fat distribution, we used the waist circumference (WC). The cut-off points of waist measurement that are used are 102 cm and 88 cm for men and women respectively. A high sacral slope (SS) means a greater the lumbar curvature, which results in a dynamic back. Due to the correlation between SS and PI, people with high PI values generally have higher values of SS. Therefore types 1 and 2 have a low-grade PI and types 3 and 4 have a high-grade PI Analysis of 272 patient records, shows that the mean PI is significantly different in the group with a low WC compared with the group with a high WC. BMI and WC show a significant correlation with PI
- Conditions
- Low Back Pain
- Being tested
- Measurement of baseline characteristics
- Keywords
- Weight,, Body mass index, Pelvic index, Waist circumference
- Medical subject headings
- Low Back Pain, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of baseline characteristicsOther
Calculation of the correlation between BMI, WC and PI
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinopelvic parameters and correlation with BMI and WC
Cross sectional study
Measured: January 1st 2020 - December 23, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Jan 2020
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 272 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- AZ Nikolaas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Van de Kelft, M.D., PhD, AZ Nikolaas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771493
- Sponsor's protocol ID
- Vitaz Sint-Niklaas
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an analysis of patient record forms. Sharing the information would be against the privacy protection
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Spinopelvic Parameters, Body Mass Index and Waist Circumference in Patients With Chronic Non-specific Low Back Pain: an Observational Cross-sectional Correlation Study
- ClinicalTrials.gov ID
- NCT05771493
- Acronym / sponsor ID
- Vitaz Sint-Niklaas
- Conditions
- Low Back Pain
- Keywords
- Weight,, Body mass index, Pelvic index, Waist circumference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- AZ NikolaasUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 16 Mar 2023 (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.
This pilot study aims at styding the correlations between body mass index, waist circumference and the potential for positional adaptation of the pelvis to support overweight or obesity
Detailed description
Record cards of patients presenting with non specific low back pain between January 1st 2020 and December 23rd 2022 were analysed.
All included patients had undergone a full spine X-ray allowing to calculate the pelvic index (PI). Weight status was described in 4 categories, in-line with the WHO definitions; Underweight (boddy mass index (BMI)) < 18.5 kg/m²; normal weight BMI 18.5 - 24.9 kg/m² , overweight BMI 25 - 29.9 kg/m², and obesity BMI ≥ 30 kg/m². To identify people with increased BMI-values and central (abdominal) fat distribution, we used the waist circumference (WC). The cut-off points of waist measurement that are used are 102 cm and 88 cm for men and women respectively. A high sacral slope (SS) means a greater the lumbar curvature, which results in a dynamic back. Due to the correlation between SS and PI, people with high PI values generally have higher values of SS. Therefore types 1 and 2 have a low-grade PI and types 3 and 4 have a high-grade PI Analysis of 272 patient records, shows that the mean PI is significantly different in the group with a low WC compared with the group with a high WC. BMI and WC show a significant correlation with PI
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 272 patients; 51.8% male, 3.7% underweight; 28.7 % normal weight; 34.2% overweight and 33.5% obees. 50.4% has high WC. Mean PI 57.78
Key inclusion criteria (2 listed)
- presenting with non-specific low back pain
- having undergone full spine X-ray during the diagnostic proces
Key exclusion criteria (2 listed)
- patients with missing data
- double entry of patients
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 |
|---|---|---|
| Measurement of baseline characteristicsCalculation of the correlation between BMI, WC and PI | Other | – |
Primary outcome
Spinopelvic parameters and correlation with BMI and WC
Time frame: January 1st 2020 - December 23, 2022
Cross sectional study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: No. This is an analysis of patient record forms. Sharing the information would be against the privacy protection
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by AZ Nikolaas at 1 site in Belgium.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Mar 2023. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinopelvic parameters and correlation with BMI and WC (time frame: January 1st 2020 - December 23, 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2023.