Low Back PainNCT03406624
Epigenetic and Molecular Biomarkers in Chronic Low Back Pain and Modic Changes
An observational study of Low Back Pain, run by Oslo University Hospital at 4 sites in Norway.
Trial summary
In the present study the investigators aim to examine the presence of bacteria in the disc and Modic Changes (MCs) (bone). A prospective study with 1-year follow-up of two patient populations undergoing elective spinal surgery (spinal fusion or disc herniation surgery) will be conducted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 4 sitesNorway
- Study dates
- 29 Jan 2018to 3 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from orthopaedic outpatient clinics at four university hospitals. They will be asked for participation after being scheduled for surgery with lumbar spinal fusion with procedures involving moderate to extensive removal of the disc (i.e. transforaminal lumbar interbody fusion (TLIF), posterior Lumbar Interbody Fusion (PLIF)) or or disc herniation surgery.
Who may be able to join
- Patients scheduled for surgery with lumbar spinal fusion with procedures involving moderate to extensive removal of the disc or disc herniation surgery (for cases: MC seen on MRI at the actual level for surgery, for controls: no MC seen on MRI at the actual level for surgery)
- LBP in the area below the 12th rib and above the gluteal folds
- Age > 18 years
- Written informed consent
Who cannot join
- Antibiotic treatment within the preceding one month before surgery
- Use of glucocorticoids the preceding month before surgery
- Small dots (i.e. <= 5 mm or height <10% of vertebra) are not included for any cases or control group
- Unwilling to participate
- Contraindications to MRI
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Haukeland University Hospital
Bergen, Bergen, 5021
Akershus University Hospital
Lørenskog, Lørenskog, 1478
Oslo University Hospital Ullevål
Oslo, Oslo, 4950
Stavanger Universitetssjukehus
Stavanger
About this study
In the present study the investigators aim to examine the presence of bacteria in the disc and Modic Changes (MCs) (bone). A prospective study with 1-year follow-up of two patient populations undergoing elective spinal surgery (spinal fusion or disc herniation surgery) will be conducted. Patients previously operated on at index level will also be included, and evaluated as sub-groups.
The following tissues are collected: dermis, sub-fascial tissue, nucleus pulposus, annulus fibrosus, and endplates. Endplate and annular biopsies are only performed in patients undergoing fusion surgery. In addition, air samples from the operating theatre during surgery are collected as negative controls.
Read more
All tissue samples undergoing culturing should be processed within 4 hours of sampling. The time for sampling and culture processing is noted for each sample. Details are available in a published Method article.
For each tissue sample, bacterial growth is recorded and the bacteria are identified at species level. Initially, the microbiologist grades the plates as "no growth", "possible contamination", and "significant growth".
"Possible contamination" means that the bacteria may be derived from the environment and could have been introduced at any step from the sample is taken to the analyses in the laboratory. Therefore, we have included negative controls in each step.
The investigators will perform direct 16S rDNA amplicon nanopore sequencing on all frozen tissue samples and air samples. Nanopore sequence reads are searched against a 16S rDNA database and the read counts per bacterium are evaluated for each sequencing batch containing 96 samples with regard to the included negative and positive controls.
Other broad metagenomic methods may be considered, e.g. Illumina sequencing.
Since Cutibacterium acnes is considered the main pathogen in this setting, the investigators will also use a specific PCR on all samples. To validate any positive findings, negative DNA extraction control and negative PCR control will be included in each run. Since C. acnes DNA is known to be highly prevalent within the air and environment generally, the negative controls may give a late positive signal due to environmental contamination. To reach a conclusion on either positive or negative finding for the C. acnes PCR, we will use a cutoff of 37 cycle threshold (Ct) values which is the lowest Ct value for any negative controls.
In addition, the investigators will use whole genome sequencing on C. acnes isolates for phylogenetic analyses to compare isolates found in different samples from the same patient.
In cases of a culture-negative but 16S rDNA nanopore-positive biopsy, the sample is classified as "no growth" when we find the same bacterial species in the air control sample as in the biopsy.
After the study was designed and the method article was prepared, nanopore sequencing technology became available and was incorporated into the present analysis. Although not part of the original protocol, 16S rDNA nanopore sequencing was applied to all samples to complement the diagnostic approach.
The results derived from 16S rDNA nanopore sequencing will be included as part of prespecified sensitivity analyses to evaluate the robustness of the main finding. These analyses allow assessment of whether the inclusion of sequencing-based detection influences the overall estimates and conclusions, while maintaining the original study design.
Based on cultivation alone, samples will be graded as "significant growth", "possible contamination" or "no growth". Before unblinding, in preparation for the sensitivity analyses, all samples of nucleus and annulus will be classified into a final categorization of "significant growth", "possible significant growth", "nanopore positive" or "no growth" based on cultivation and PCR (see Table 1 under Study Documents "Final categorization of bacterial growth and PCR-based methods for each tissue sample").
The microbiologists, pathologist, statistician and clinicians are blinded until end of study, April 22th 2026.
Blood-samples are collected to characterize gene expression patterns and related markers.
Read the detailed description
Planned analyses
The investigators will perform the following analyses, with terms based on final categorization above:
Primary analyses:
- Dependent variable (outcome): positive = significant growth, negative = no growth or possible significant growth. Main explanatory variable (group): MC1 vs. control II. Dependent variable (outcome): positive = significant growth, negative = no growth or possible significant growth. Main explanatory variable (group): MC2 vs. control
For each of the primary analyses (I and II), we will perform the following sensitivity analyses:
- st sensitivty analysis: Dependent variable (outcome): positive = significant growth or possible significant growth, negative = no growth and 16S rDNA nanopore sequencing positive.
- nd sensitivity analysis: Dependent variable (outcome): positive = significant growth, possible significant growth or 16S rDNA nanopore sequencing positive, negative = no growth
Exploratory analyses:
The investigators will perform exploratory analyses using the following as main explanatory variables (using the same dependent variable as the primary analysis):
I - MC1 and MC2 in previously operated vs. control II - Large MCs vs. control (significant growth from disc, yes/no). Large MCs are defined as MCs with volume ≥ 25 % of vertebral body volume or height > 50 % of vertebral body height.
III - MC1 and MC2 vs. control in fusion group (significant growth from vertebral body biopsy, yes/no). Vertebral body biopsies are not performed in the disc herniation group.
For each of these three exploratory analyses, the investigators will consider to perform similar sensitivity analyses as for the primary analyses, depending on the results of those.
Statistics and power:
The main aim of this study is to investigate if the proportions of patients with significant bacterial growth from perioperative disc biopsies differ between cases (MC1 patients or MC2 patients) vs controls without MCs. The null hypothesis is that there is no difference between cases and controls. The alternative hypothesis is that there is a difference.
The sample size calculation is based on previously published data and a pre-specified relevant difference in proportions of bacterial growth among cases vs. controls
The investigators calculated the sample size using a two-sided Pearson's chi-squared test. For the primary analysis, with two primary endpoints, the investigators aim to achieve 80 % power to detect a difference in bacterial growth in 25 % of cases with MC1 or MC2 vs. 5% of controls. Due to multiple testing the investigators use Bonferroni correction (alfa 0.025). The investigators therefore plan to analyze at least 60 cases with MC1, 60 cases with MC2 and 60 controls.
The MC2 sample is likely to become larger than n = 60, since the investigators recruit MC1 and MC2 patients consecutively and MC2 is more common than MC1.
The primary endpoint will be analyzed with a logistic regression model with bacterial growth (positive/negative) as the outcome and group (MC1 or MC2 vs. control) as the main explanatory variable.
After fitting the model, the model-predicted marginal probabilities of positive bacterial findings will be estimated for both groups. The effect measure will be the difference between the two probabilities, and will be reported with a 95 % confidence interval and a P-value for the null hypothesis of a zero difference. The standard error of the difference will be estimated using the delta method.
The exploratory and sensitivity analyses will be carried out with the same model, after replacing outcome and main explanatory variable as appropriate. The subgroup analysis of previously operated will be carried out by adding previously operated as an interaction term between groups, and previously operated as covariates in the logistic model. A significant coefficient for the interaction term will indicate a subgroup effect.
- Conditions
- Low Back Pain
- Being tested
- Biopsy
- Keywords
- Modic changes, biomarkers, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Biopsies will be taken from disc and / or endplates during elective lumbar fusion surgery or disc herniation surgery (endplate biopsy is omitted in disc herniation surgery)
| Study group | Role | What they receive |
|---|---|---|
| Spinal fusion with modic changes | Patients scheduled for surgery with lumbar spinal fusion with procedures involving moderate to extensive removal of the disc, and with modic changes seen on MRI at the actual level for surgery Receives: Procedure: Biopsy | |
| Spinal fusion without modic changes | Patients scheduled for surgery with lumbar spinal fusion with procedures involving moderate to extensive removal of the disc, but with no modic changes seen on MRI at the actual level for surgery Receives: Procedure: Biopsy | |
| Disc herniation surgery with modic changes | Patients scheduled for disc herniation surgery, and with modic changes seen on MRI at the actual level for surgery Receives: Procedure: Biopsy | |
| Disc herniation surgery without modic changes | Patients scheduled for disc herniation surgery, but with no modic changes seen on MRI at the actual level for surgery Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological analysis (aerob, anaerob cultivation)
Measured: During surgery
Histopathology and PCR
Measured: During surgery
Gene expression profiling
Measured: During surgery
Secondary outcomes (7)
Oswestry disability index
The Oswestry Disability Index (ODI) provides the level of self-reported impairment of activity of daily living due to low back pain. There are 10 items in the ODI, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'.
Measured: Pre surgery, 3 and 12 months postoperatively
Roland and Morris Disability Questionnaire
The Roland Morris Questionnaire (RMQ) provides the level of self-reported impairment of activity of daily living due to low back pain. There are 24 items in the RMQ, each answered yes/no on a dichotomous questionnaire. All items answered with "yes" are summarized into a scale ranging from 0='no impairment' to 24='complete impairment'.
Measured: Pre surgery, 3 and 12 months postoperatively
Low back pain
Self-reported level of low back pain, measured on a 0 to 10 Likert scale anchored by 0 indicating "no pain" and 10 indicating "unbearable pain".
Measured: Pre surgery, 3 and 12 months postoperatively
Leg pain
Self-reported level of leg pain, measured on a 0 to 10 Likert scale anchored by 0 indicating "no pain" and 10 indicating "unbearable pain".
Measured: Pre surgery, 3 and 12 months postoperatively
Health-related quality of life (EQ-5D)
EQ-5D, measuring patients health-related quality of life, have 5 dimensions: "Mobility", "Human Autonomy," "Current Daily Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by 5 problem levels corresponding to patient response choices. A quality of life score is obtained according to the answers to the questionnaires.
Measured: Pre surgery, 3 and 12 months postoperatively
Magnetic Resonance Imaging
Magnetic Resonance Imaging (MRI): Sagittal T1- and T2 weighted images, axial T2 weighted images, sagittal short tau inversion recovery (STIR) images, sagittal fat-water separation images, sagittal diffusion weighted images (DWI), and sagittal T1 weighted DCE images (only if the patient can receive gadolinium injection). The same MRI protocol and the same type of 1.5 Tesla MRI scanners will be used at all study sites.
Measured: Pre surgery and 12 months postoperatively (12 months postoperatively only for patients undergoing lumbar disc herniation surgery
Blood samples
Measured: Pre surgery and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start29 Jan 2018
- Primary completion3 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, University Hospital, Akershus, Helse Stavanger HF
- Responsible party
- Principal investigator, Kjersti Storheim, Oslo University Hospital
- Investigators
- Smeland, Professor, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406624
- Sponsor's protocol ID
- 2015/697
- Status last verified
- Apr 2026
- First submitted
- 20 Dec 2017
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rolfsen MP, Gammelsrud KW, Espeland A, Braten LC, Mjones SB, Austevoll I, Dolatowski FC, Arrestad MB, Toppe MK, Orlien IE, Holberg-Petersen M, Fagerland M, Zwart JA, Storheim K, Hellum C. Bacterial growth in patients with low back pain and Modic changes: protocol of a multicentre, case-control biopsy study. BMJ Open. 2024 May 6;14(5):e082244. doi: 10.1136/bmjopen-2023-082244.
PubMed 38719329
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic and Molecular Biomarkers in Chronic Low Back Pain and Modic Changes
- ClinicalTrials.gov ID
- NCT03406624
- Acronym / sponsor ID
- 2015/697
- Conditions
- Low Back Pain
- Keywords
- Modic changes, biomarkers, low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, University Hospital, Akershus, Helse Stavanger HF
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 3 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 23 Jan 2018 (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.
In the present study the investigators aim to examine the presence of bacteria in the disc and Modic Changes (MCs) (bone). A prospective study with 1-year follow-up of two patient populations undergoing elective spinal surgery (spinal fusion or disc herniation surgery) will be conducted. Patients previously operated on at index level will also be included, and evaluated as sub-groups.
The following tissues are collected: dermis, sub-fascial tissue, nucleus pulposus, annulus fibrosus, and endplates. Endplate and annular biopsies are only performed in patients undergoing fusion surgery. In addition, air samples from the operating theatre during surgery are collected as negative controls.
All tissue samples undergoing culturing should be processed within 4 hours of sampling. The time for sampling and culture processing is noted for each sample. Details are available in a published Method article.
For each tissue sample, bacterial growth is recorded and the bacteria are identified at species level. Initially, the microbiologist grades the plates as "no growth", "possible contamination", and "significant growth".
"Possible contamination" means that the bacteria may be derived from the environment and could have been introduced at any step from the sample is taken to the analyses in the laboratory. Therefore, we have included negative controls in each step.
The investigators will perform direct 16S rDNA amplicon nanopore sequencing on all frozen tissue samples and air samples. Nanopore sequence reads are searched against a 16S rDNA database and the read counts per bacterium are evaluated for each sequencing batch containing 96 samples with regard to the included negative and positive controls.
Other broad metagenomic methods may be considered, e.g. Illumina sequencing.
Since Cutibacterium acnes is considered the main pathogen in this setting, the investigators will also use a specific PCR on all samples. To validate any positive findings, negative DNA extraction control and negative PCR control will be included in each run. Since C. acnes DNA is known to be highly prevalent within the air and environment generally, the negative controls may give a late positive signal due to environmental contamination. To reach a conclusion on either positive or negative finding for the C. acnes PCR, we will use a cutoff of 37 cycle threshold (Ct) values which is the lowest Ct value for any negative controls.
In addition, the investigators will use whole genome sequencing on C. acnes isolates for phylogenetic analyses to compare isolates found in different samples from the same patient.
In cases of a culture-negative but 16S rDNA nanopore-positive biopsy, the sample is classified as "no growth" when we find the same bacterial species in the air control sample as in the biopsy.
After the study was designed and the method article was prepared, nanopore sequencing technology became available and was incorporated into the present analysis. Although not part of the original protocol, 16S rDNA nanopore sequencing was applied to all samples to complement the diagnostic approach.
The results derived from 16S rDNA nanopore sequencing will be included as part of prespecified sensitivity analyses to evaluate the robustness of the main finding. These analyses allow assessment of whether the inclusion of sequencing-based detection influences the overall estimates and conclusions, while maintaining the original study design.
Based on cultivation alone, samples will be graded as "significant growth", "possible contamination" or "no growth". Before unblinding, in preparation for the sensitivity analyses, all samples of nucleus and annulus will be classified into a final categorization of "significant growth", "possible significant growth", "nanopore positive" or "no growth" based on cultivation and PCR (see Table 1 under Study Documents "Final categorization of bacterial growth and PCR-based methods for each tissue sample").
The microbiologists, pathologist, statistician and clinicians are blinded until end of study, April 22th 2026.
Blood-samples are collected to characterize gene expression patterns and related markers.
Detailed description
Planned analyses
The investigators will perform the following analyses, with terms based on final categorization above:
Primary analyses:
- Dependent variable (outcome): positive = significant growth, negative = no growth or possible significant growth. Main explanatory variable (group): MC1 vs. control II. Dependent variable (outcome): positive = significant growth, negative = no growth or possible significant growth. Main explanatory variable (group): MC2 vs. control
For each of the primary analyses (I and II), we will perform the following sensitivity analyses:
- st sensitivty analysis: Dependent variable (outcome): positive = significant growth or possible significant growth, negative = no growth and 16S rDNA nanopore sequencing positive.
- nd sensitivity analysis: Dependent variable (outcome): positive = significant growth, possible significant growth or 16S rDNA nanopore sequencing positive, negative = no growth
Exploratory analyses:
The investigators will perform exploratory analyses using the following as main explanatory variables (using the same dependent variable as the primary analysis):
I - MC1 and MC2 in previously operated vs. control II - Large MCs vs. control (significant growth from disc, yes/no). Large MCs are defined as MCs with volume ≥ 25 % of vertebral body volume or height > 50 % of vertebral body height.
III - MC1 and MC2 vs. control in fusion group (significant growth from vertebral body biopsy, yes/no). Vertebral body biopsies are not performed in the disc herniation group.
For each of these three exploratory analyses, the investigators will consider to perform similar sensitivity analyses as for the primary analyses, depending on the results of those.
Statistics and power:
The main aim of this study is to investigate if the proportions of patients with significant bacterial growth from perioperative disc biopsies differ between cases (MC1 patients or MC2 patients) vs controls without MCs. The null hypothesis is that there is no difference between cases and controls. The alternative hypothesis is that there is a difference.
The sample size calculation is based on previously published data and a pre-specified relevant difference in proportions of bacterial growth among cases vs. controls
The investigators calculated the sample size using a two-sided Pearson's chi-squared test. For the primary analysis, with two primary endpoints, the investigators aim to achieve 80 % power to detect a difference in bacterial growth in 25 % of cases with MC1 or MC2 vs. 5% of controls. Due to multiple testing the investigators use Bonferroni correction (alfa 0.025). The investigators therefore plan to analyze at least 60 cases with MC1, 60 cases with MC2 and 60 controls.
The MC2 sample is likely to become larger than n = 60, since the investigators recruit MC1 and MC2 patients consecutively and MC2 is more common than MC1.
The primary endpoint will be analyzed with a logistic regression model with bacterial growth (positive/negative) as the outcome and group (MC1 or MC2 vs. control) as the main explanatory variable.
After fitting the model, the model-predicted marginal probabilities of positive bacterial findings will be estimated for both groups. The effect measure will be the difference between the two probabilities, and will be reported with a 95 % confidence interval and a P-value for the null hypothesis of a zero difference. The standard error of the difference will be estimated using the delta method.
The exploratory and sensitivity analyses will be carried out with the same model, after replacing outcome and main explanatory variable as appropriate. The subgroup analysis of previously operated will be carried out by adding previously operated as an interaction term between groups, and previously operated as covariates in the logistic model. A significant coefficient for the interaction term will indicate a subgroup effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Spinal fusion with modic changes | – | Procedure: BiopsyPatients scheduled for surgery with lumbar spinal fusion with procedures involving moderate to extensive removal of the disc, and with modic changes seen on MRI at the actual level for surgery |
| Spinal fusion without modic changes | – | Procedure: BiopsyPatients scheduled for surgery with lumbar spinal fusion with procedures involving moderate to extensive removal of the disc, but with no modic changes seen on MRI at the actual level for surgery |
| Disc herniation surgery with modic changes | – | Procedure: BiopsyPatients scheduled for disc herniation surgery, and with modic changes seen on MRI at the actual level for surgery |
| Disc herniation surgery without modic changes | – | Procedure: BiopsyPatients scheduled for disc herniation surgery, but with no modic changes seen on MRI at the actual level for surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from orthopaedic outpatient clinics at four university hospitals. They will be asked for participation after being scheduled for surgery with lumbar spinal fusion with procedures involving moderate to extensive removal of the disc (i.e. transforaminal lumbar interbody fusion (TLIF), posterior Lumbar Interbody Fusion (PLIF)) or or disc herniation surgery.
Key inclusion criteria (4 listed)
- Patients scheduled for surgery with lumbar spinal fusion with procedures involving moderate to extensive removal of the disc or disc herniation surgery (for cases: MC seen on MRI at the actual level for surgery, for controls: no MC seen on MRI at the actual level for surgery)
- LBP in the area below the 12th rib and above the gluteal folds
- Age > 18 years
- Written informed consent
Key exclusion criteria (5 listed)
- Antibiotic treatment within the preceding one month before surgery
- Use of glucocorticoids the preceding month before surgery
- Small dots (i.e. <= 5 mm or height <10% of vertebra) are not included for any cases or control group
- Unwilling to participate
- Contraindications to MRI
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 |
|---|---|---|
| BiopsyBiopsies will be taken from disc and / or endplates during elective lumbar fusion surgery or disc herniation surgery (endplate biopsy is omitted in disc herniation surgery) | Procedure or surgery | Disc herniation surgery with modic changes, Disc herniation surgery without modic changes, Spinal fusion with modic changes, Spinal fusion without modic changes |
Primary outcome
Microbiological analysis (aerob, anaerob cultivation)
Time frame: During surgery
Histopathology and PCR
Time frame: During surgery
Gene expression profiling
Time frame: During surgery
7 secondary outcomes
Oswestry disability index
Time frame: Pre surgery, 3 and 12 months postoperatively
Roland and Morris Disability Questionnaire
Time frame: Pre surgery, 3 and 12 months postoperatively
Low back pain
Time frame: Pre surgery, 3 and 12 months postoperatively
Leg pain
Time frame: Pre surgery, 3 and 12 months postoperatively
Health-related quality of life (EQ-5D)
Time frame: Pre surgery, 3 and 12 months postoperatively
Magnetic Resonance Imaging
Time frame: Pre surgery and 12 months postoperatively (12 months postoperatively only for patients undergoing lumbar disc herniation surgery
Blood samples
Time frame: Pre surgery and 12 months postoperatively
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 28 Apr 2026.
- Derived from this study: PubMed 38719329Rolfsen MP, Gammelsrud KW, Espeland A, Braten LC, Mjones SB, Austevoll I, Dolatowski FC, Arrestad MB, Toppe MK, Orlien IE, Holberg-Petersen M, Fagerland M, Zwart JA, Storheim K, Hellum C. Bacterial growth in patients with low back pain and Modic changes: protocol of a multicentre, case-control biopsy study. BMJ Open. 2024 May 6;14(5):e082244. doi: 10.1136/bmjopen-2023-082244.
- Individual participant dataSharing planned: No
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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.
Smeland, Professor study director
Oslo University Hospital
4 sites 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 Oslo University Hospital at 4 sites in Norway.
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 4 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: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. 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?
Microbiological analysis (aerob, anaerob cultivation) (time frame: During surgery). The study lists 3 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 NCT03406624, which also lists 1 linked publication.
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 28 Apr 2026.