Trial · NCT07886697
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 | Change From Baseline in Average Index-Knee Pain Intensity at Day 90 | Baseline and Day 90 (90 ± 14 days after the last radiotherapy fraction) | Average pain intensity in the index knee during the previous 7 days will be assessed using an 11-point Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Change will be calculated as baseline NRS minus Day 90 NRS. Positive values indicate improvement, zero indicates no change, and negative values indicate worsening. |
| Secondary | Change From Baseline in Average Index-Knee Pain Intensity at Day 45 | Baseline and Day 45 (45 ± 7 days after the last radiotherapy fraction) | Average pain intensity in the index knee during the previous 7 days will be assessed using an 11-point Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Change will be calculated as baseline NRS minus Day 45 NRS. Positive values indicate improvement, zero indicates no change, and negative values indicate worsening. |
| Secondary | Change From Baseline in WOMAC Pain Subscale Score | Baseline, Day 45 (45 ± 7 days after the last radiotherapy fraction), and Day 90 (90 ± 14 days after the last radiotherapy fraction) | The WOMAC pain subscale consists of 5 items, each scored from 0 to 4, yielding a total score from 0 to 20. Higher scores indicate greater pain. Change from baseline will be assessed at Day 45 and Day 90. |
| Secondary | Change From Baseline in WOMAC Stiffness Subscale Score | Baseline, Day 45 (45 ± 7 days after the last radiotherapy fraction), and Day 90 (90 ± 14 days after the last radiotherapy fraction) | The WOMAC stiffness subscale consists of 2 items, each scored from 0 to 4, yielding a total score from 0 to 8. Higher scores indicate greater stiffness. Change from baseline will be assessed at Day 45 and Day 90. |
| Secondary | Change From Baseline in WOMAC Physical Function Subscale Score | Baseline, Day 45 (45 ± 7 days after the last radiotherapy fraction), and Day 90 (90 ± 14 days after the last radiotherapy fraction) | The WOMAC physical function subscale consists of 17 items, each scored from 0 to 4, yielding a total score from 0 to 68. Higher scores indicate greater functional limitation. Change from baseline will be assessed at Day 45 and Day 90. |
| Secondary | Change From Baseline in KOOS-PS Score | Baseline, Day 45 (45 ± 7 days after the last radiotherapy fraction), and Day 90 (90 ± 14 days after the last radiotherapy fraction) | The 7-item Knee injury and Osteoarthritis Outcome Score-Physical Function Shortform (KOOS-PS) will be used to assess physical function. The raw score will be transformed to a 0-to-100 Rasch-based score, where 0 indicates no difficulty and 100 indicates extreme difficulty. Change from baseline will be assessed at Day 45 and Day 90. |
| Secondary | Change From Baseline in EQ-5D-3L Health Utility Index | Baseline, Day 45 (45 ± 7 days after the last radiotherapy fraction), and Day 90 (90 ± 14 days after the last radiotherapy fraction) | Health-related quality of life will be assessed using the Spanish EQ-5D-3L. The health utility index will be calculated from the five dimensions using the Spanish value set. Higher index values indicate better health status. Change from baseline will be assessed at Day 45 and Day 90. |
| Secondary | Change From Baseline in EQ VAS Score | Baseline, Day 45 (45 ± 7 days after the last radiotherapy fraction), and Day 90 (90 ± 14 days after the last radiotherapy fraction) | Overall health status will be assessed using the EQ Visual Analogue Scale (EQ VAS), ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Change from baseline will be assessed at Day 45 and Day 90. |
| Secondary | Change From Baseline in Patient Global Assessment of the Index Knee | Baseline, Day 45 (45 ± 7 days after the last radiotherapy fraction), and Day 90 (90 ± 14 days after the last radiotherapy fraction) | Patient Global Assessment (PGA) will evaluate the overall impact of index-knee osteoarthritis during the previous 7 days using a 0-to-100 scale. Participants will answer: "Considering all the ways in which the osteoarthritis of your index knee affects you, how would you rate your knee during the past 7 days?" A score of 0 indicates very well/no impact and 100 indicates very poorly/maximum impact. Change from baseline will be assessed at Day 45 and Day 90. |
| Secondary | Proportion of Participants With at Least a 30% Reduction in NRS Pain Intensity | Day 45 (45 ± 7 days after the last radiotherapy fraction) and Day 90 (90 ± 14 days after the last radiotherapy fraction) | A pain responder will be defined as a participant with at least a 30% reduction from baseline in average index-knee pain intensity measured using the 0-to-10 Numerical Rating Scale (NRS). Percentage reduction will be calculated as \[(baseline NRS - follow-up NRS) / baseline NRS\] × 100. The proportion of participants meeting this criterion will be assessed at Day 45 and Day 90. |
| Secondary | Proportion of Participants With at Least a 50% Reduction in NRS Pain Intensity | Day 45 (45 ± 7 days after the last radiotherapy fraction) and Day 90 (90 ± 14 days after the last radiotherapy fraction) | A pain responder will be defined as a participant with at least a 50% reduction from baseline in average index-knee pain intensity measured using the 0-to-10 Numerical Rating Scale (NRS). Percentage reduction will be calculated as \[(baseline NRS - follow-up NRS) / baseline NRS\] × 100. The proportion of participants meeting this criterion will be assessed at Day 45 and Day 90. |
| Secondary | Proportion of Participants Meeting OMERACT-OARSI Responder Criteria | Day 45 (45 ± 7 days after the last radiotherapy fraction) and Day 90 (90 ± 14 days after the last radiotherapy fraction) | Participants will be classified as OMERACT-OARSI responders if they meet either of the following criteria: (1) high improvement in pain or physical function, defined as an improvement of at least 50% and an absolute improvement of at least 20 points on a 0-to-100 scale; or (2) improvement in at least 2 of 3 domains-pain, physical function, and Patient Global Assessment-defined as an improvement of at least 20% and an absolute improvement of at least 10 points on a 0-to-100 scale. The proportion of responders will be assessed at Day 45 and Day 90. |
| Secondary | Participants With Changes in Analgesic Treatment or Rescue Medication Use | From baseline through Day 90 (90 ± 14 days after the last radiotherapy fraction) | Changes in analgesic treatment for index-knee osteoarthritis will be recorded throughout follow-up, including initiation, discontinuation, or dose modification of analgesic medication and use of rescue medication. The proportion of participants with at least one change in analgesic treatment or rescue medication use will be summarized through Day 90. |
| Secondary | Participants Receiving an Index-Knee Co-intervention During Follow-up | From baseline through Day 90 (90 ± 14 days after the last radiotherapy fraction) | Index-knee co-interventions during follow-up will be recorded, including intra-articular corticosteroid or hyaluronic acid injections, radiofrequency procedures, other interventional procedures, or surgery. The proportion of participants receiving at least one such co-intervention will be summarized through Day 90. |
| Secondary | Proportion of Participants Completing the Planned Radiotherapy Course | From the first radiotherapy fraction through completion of the planned course (approximately 3 weeks) | Treatment completion will be defined as receipt of all six planned radiotherapy fractions of 0.5 Gy each, corresponding to a total prescribed dose of 3.0 Gy to the index knee. The proportion of participants completing the planned radiotherapy course will be summarized. |
| Secondary | Incidence and Severity of Adverse Events | From the first radiotherapy fraction through Day 90 (90 ± 14 days after the last radiotherapy fraction) | Adverse events occurring from the first radiotherapy fraction through Day 90 will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. For each event, the event term, severity grade, onset and resolution dates, relationship to radiotherapy, actions taken, treatment required, and outcome will be documented. The incidence and severity of adverse events will be summarized. |
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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