Trial · NCT07906431
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Lumbar pain intensity (Visual Analogue Scale) | Baseline and 1 week after the end of the assigned intervention (week 10 in the radiofrequency arm; week 13 in the exercise and combined arms) | Lumbar pain intensity on a 10-cm visual analogue scale (0 = no pain, 10 = worst imaginable pain). Higher scores indicate worse pain. |
| Secondary | Lumbar pain intensity during follow-up (Visual Analogue Scale) | 1 month and 3 months after the end of the assigned intervention | 0-10 cm VAS as for the primary outcome, assessed during follow-up. Higher scores indicate worse pain. |
| Secondary | Lumbar pain intensity at a common calendar time point (VAS) | 13 weeks after randomisation | Pre-specified sensitivity analysis: 0-10 cm VAS compared among groups when all participants have completed their assigned programme. |
| Secondary | Pain quality (McGill Pain Questionnaire) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | McGill Pain Questionnaire scored from descriptors selected across the sensory and affective subclasses. Higher scores indicate greater pain. |
| Secondary | Low back disability (Oswestry Disability Index) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | ODI, 0-100%. Higher scores indicate greater disability; a change of about 10 points is considered clinically important. |
| Secondary | Pelvic floor symptom distress (PFDI-20) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | Pelvic Floor Distress Inventory-20 total score (0-300). Higher scores indicate greater symptom distress. |
| Secondary | Urinary incontinence (ICIQ-UI SF) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | ICIQ Urinary Incontinence Short Form total score (0-21), covering frequency, amount and impact on quality of life. Higher scores indicate greater severity. |
| Secondary | Pelvic floor muscle function (PERFECT scheme) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | Digital vaginal assessment in lithotomy after voiding and 3 minutes of seated rest: power, endurance (s), repetitions and fast contractions (number per 10 s). |
| Secondary | Pelvic floor muscle strength (Modified Oxford Scale) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | Best of three maximal voluntary contractions on digital palpation, graded 0 (no contraction) to 5 (strong). Higher grades indicate greater strength. |
| Secondary | Intravaginal pressure (manometry) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | Phenix Liberty manometer with an air-filled vaginal probe: resting tone and mean of three maximal 10-second contractions (cmH2O/mmHg). |
| Secondary | Lumbar flexion mobility (Modified Schober test) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | Lumbar flexion mobility measured with the modified Schober test (cm). |
| Secondary | Lumbar extension | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | Passive lumbar extension test (positive/negative) |
| Secondary | Kinesiophobia (Tampa Scale for Kinesiophobia, TSK-17) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | TSK-17 total score (17 items; range 17-68). Higher scores indicate greater fear of movement or re-injury. |
| Secondary | Pain catastrophising (Pain Catastrophizing Scale, PCS) | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | PCS total score (13 items; range 0-52). Higher scores indicate greater pain catastrophising. |
| Secondary | lateral flexion | Baseline, and 1 week, 1 month and 3 months after the end of the assigned intervention. | bilateral side-bending fingertip-to-thigh distance (cm; difference below 10 cm classified as restricted). |
| Other | Adverse events | From first intervention session to 3 months after the end of the assigned intervention | Number of participants with adverse events (e.g. burns, marked irritation, persistent pain), by group, relatedness and seriousness. |
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.
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