Trial · NCT07895589
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants undergoing lumbar disc surgery | Within 12 months after randomisation | Proportion of participants who undergo surgery for the index lumbar disc herniation within 12 months after randomisation. The outcome is recorded for each participant as yes or no. |
| Secondary | Time to lumbar disc surgery | From randomisation to 12 months | Number of days from randomisation to the first surgery for the index lumbar disc herniation. Participants without surgery will be censored at their last follow-up or at 365 days, whichever occurs first. |
| Secondary | Leg pain intensity measured using the Visual Analogue Scale | Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation | Leg pain intensity measured using a Visual Analogue Scale (VAS) ranging from 0 to 100 mm, with higher scores indicating greater pain. The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses. |
| Secondary | Back pain intensity measured using the Visual Analogue Scale | Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation | Back pain intensity measured using a Visual Analogue Scale (VAS) ranging from 0 to 100 mm, with higher scores indicating greater pain. The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses. |
| Secondary | Leg pain intensity measured using the Numeric Rating Scale | Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation | Leg pain intensity measured using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses. |
| Secondary | Back pain intensity measured using the Numeric Rating Scale | Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation | Back pain intensity measured using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses. |
| Secondary | Oswestry Disability Index | Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation | Disability measured using the Oswestry Disability Index (ODI), version 2.0. Scores range from 0 to 100, with higher scores indicating greater disability. The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses. |
| Secondary | Health-related quality of life measured using the EQ-5D-3L index | Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation | Health-related quality of life measured using the EQ-5D-3L descriptive system and converted to an index using the selected value set. Higher index values indicate better health; 1 represents full health, and negative values represent health states valued below death. The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses. |
| Secondary | Self-rated health measured using the EQ-VAS | Baseline; 2 days, 2 weeks, 6 weeks, 3 months and 12 months after randomisation | EQ-VAS, ranging from 0 (worst imaginable health) to 100 (best imaginable health). The prespecified secondary comparison is at 12 months after randomisation. Earlier measurements will be used for descriptive and exploratory analyses. |
| Secondary | Duration of sick leave | From randomisation to 12 months | Duration of sick leave during the follow-up period, recorded in days. |
| Secondary | Extent of sick leave | From randomisation to 12 months | Extent of sick leave during the follow-up period. Data will be collected from medical records, the Swedish Spine Registry (Swespine) and the Swedish Social Insurance Agency (Försäkringskassan). |
| Secondary | Healthcare visits related to lumbar disc herniation | From randomisation to 12 months | Number of healthcare visits related to lumbar disc herniation or its treatment during the follow-up period. |
| Secondary | Hospitalisations related to lumbar disc herniation | From randomisation to 12 months | Number of hospitalisations related to lumbar disc herniation or its treatment during the follow-up period. |
| Secondary | Re-interventions | From randomisation to 12 months | Number and type of additional interventions for lumbar disc herniation during the follow-up period, including additional nerve root injections outside the study protocol. |
| Secondary | Hospital readmissions | From randomisation to 12 months | Number of hospital readmissions related to lumbar disc herniation or its treatment during the follow-up period. |
| Secondary | Revision lumbar disc surgery | From randomisation to 12 months | Number of revision operations following the index lumbar disc surgery during the follow-up period. |
| Secondary | Adverse events | From randomisation to 12 months | Number and type of adverse events, including bleeding, infection, neurological deterioration, allergic reactions, steroid-related complications and vasovagal reactions. Severity will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events |
| Secondary | Serious adverse event | From randomisation to 12 months | Number and type of serious adverse events, defined according to Good Clinical Practice criteria, including death, life-threatening events and events requiring or prolonging hospitalisation. |
| Secondary | Surgical complications | From randomisation to 12 months | Number and severity of surgical complications among participants undergoing surgery, classified using the Clavien-Dindo classification and categorised as minor or major according to the protocol. |
| Secondary | Analgesic use | From randomisation to 12 months | Administered and prescribed doses of analgesics during follow-up. Opioid doses will be converted to oral morphine equivalents where applicable. |
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
Read this list from software.
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