An observational study in LUMBAR STENOSIS, sponsored by Aalborg University. Enrolling by invitation at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Aalborg University · Observational
This prospective observational cohort study aims to determine whether a combination of preoperative clinical, psychological, sleep-related, inflammatory, genetic, and epigenetic factors can predict chronic postoperative pain 12 months after microsurgical decompression surgery in patients with lumbar spinal stenosis. Participants will undergo preoperative blood sampling and questionnaire assessment before surgery and complete follow-up questionnaires 12 months after surgery.
Lumbar spinal stenosis is a common cause of pain and disability, and although microsurgical decompression surgery is effective for many patients, some continue to experience chronic postoperative pain. Previous studies have identified risk factors related to pain mechanisms, psychological characteristics, inflammation, and molecular biomarkers, but currently no predictive model has sufficient accuracy for clinical use. This study investigates whether combining multiple preoperative assessments can improve prediction of chronic postoperative pain 12 months after surgery. Variables include pain-related questionnaires, sleep quality, inflammatory biomarkers, circulating microRNAs, telomere length, and circulating nucleosome epigenomic profiling. Machine learning methods will be employed to develop predictive models.
1,117 studies on the registry are indexed under Constriction, Pathologic; 229 are open to participants now.
This study's planned enrollment of 200 is above the median of 121 across 391 observational studies indexed under Constriction, Pathologic.
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Adults aged 18-80 years with symptomatic lumbar spinal stenosis and radiating leg pain who are scheduled to undergo microsurgical decompression surgery. Participants will be recruited preoperatively and followed for 12 months after surgery to evaluate chronic postoperative pain outcomes.
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Exclusion Criteria:
Chronic postoperative pain at 12 months
Chronic postoperative pain will be assessed 12 months after microsurgical decompression surgery using an 11-point Numeric Rating Scale (NRS). Participants will rate their average pain intensity during the previous week on a scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores indicate greater pain intensity and a less favorable outcome.
Time frame: From enrollment to the 12-month follow-up
Roland-Morris Disability Questionnaire (RMDQ) Score
Back pain-related disability assessed using the Roland-Morris Disability Questionnaire. Total scores range from 0 to 24, with higher scores indicating greater disability and functional impairment.
Time frame: From enrollment to the 12-month follow-up
PainDETECT Questionnaire Score
Chronic postoperative pain will be assessed 12 months after microsurgical decompression surgery using an 11-point Numeric Rating Scale (NRS). Participants will rate their average pain intensity during the previous week on a scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores indicate greater pain intensity and a less favorable outcome. This outcome will be used to evaluate persistent pain following surgery and as the primary endpoint for development and evaluation of prognostic prediction models.
Time frame: From enrollment to the 12-month follow-up
Pain Catastrophizing Scale
Pain-related catastrophic thinking assessed using the Pain Catastrophizing Scale. Total scores range from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.
Time frame: From enrollment to the 12-month follow-up
Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Symptoms of anxiety assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: From enrollment to the 12-month follow-up
Hospital Anxiety and Depression Scale (HADS) Depression Score
Symptoms of depression assessed using the depression subscale of the Hospital Anxiety and Depression Scale. Scores range from 0 to 21, with higher scores indicating more severe depressive symptoms.
Time frame: From enrollment to the 12-month follow-up
Pittsburgh Sleep Quality Index (PSQI) Score
Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: From enrollment to the 12-month follow-up
C-Reactive Protein (CRP)
Systemic inflammation assessed by measurement of plasma C-reactive protein concentration obtained from venous blood samples. Values are reported in mg/L, with higher values indicating greater systemic inflammatory activity.
Time frame: Immediately before surgery
Inflammatory Protein Profile
Inflammatory biomarker concentrations assessed using the Olink® Target 96 Inflammation panel. Protein expression levels are reported as Normalized Protein eXpression (NPX) values on a log2 scale, with higher NPX values indicating higher relative protein abundance.
Time frame: Immediately before surgery
Circulating microRNA Expression Profile
Circulating microRNA expression assessed from plasma samples using next-generation sequencing. Expression levels will be reported as normalized sequencing counts and used as exploratory prognostic biomarkers.
Time frame: Immediately before surgery
Telomere Length
Biological aging assessed by measurement of absolute telomere length from blood-derived DNA using quantitative polymerase chain reaction (qPCR). Telomere length will be reported as laboratory-specific quantitative measures, with shorter telomeres generally indicating greater biological aging.
Time frame: Immediately before surgery
Circulating Nucleosome Epigenomic Profile
Genome-wide epigenetic signatures assessed from circulating nucleosomes isolated from plasma samples. Analyses include DNA methylation patterns and histone post-translational modifications, reported as normalized assay-specific measures and evaluated as exploratory prognostic biomarkers.
Time frame: Immediately before surgery
Pain Medication Use
Self-reported use of analgesic medications assessed through questionnaire data. Medication use will be categorized according to type and frequency of use, with higher use reflecting a greater need for pain management.
Time frame: Immediately before surgery
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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