Trial · NCT07883694
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Chronic postoperative pain at 12 months | From enrollment to the 12-month follow-up | 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. |
| Primary | Roland-Morris Disability Questionnaire (RMDQ) Score | From enrollment to the 12-month follow-up | 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. |
| Secondary | PainDETECT Questionnaire Score | From enrollment to the 12-month follow-up | 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. |
| Secondary | Pain Catastrophizing Scale | From enrollment to the 12-month follow-up | 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. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) Anxiety Score | From enrollment to the 12-month follow-up | 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. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) Depression Score | From enrollment to the 12-month follow-up | 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. |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) Score | From enrollment to the 12-month follow-up | Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. |
| Secondary | C-Reactive Protein (CRP) | Immediately before surgery | 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. |
| Secondary | Inflammatory Protein Profile | Immediately before surgery | 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. |
| Secondary | Circulating microRNA Expression Profile | Immediately before surgery | 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. |
| Secondary | Telomere Length | Immediately before surgery | 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. |
| Secondary | Circulating Nucleosome Epigenomic Profile | Immediately before surgery | 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. |
| Secondary | Pain Medication Use | Immediately before surgery | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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