LDRT Retreatment for Knee Osteoarthritis
UW26092: Low-Dose Radiation Therapy for Osteoarthritis of the Knee: A Phase 2 Randomized Trial of Dual-Course Versus Single-Course Radiation
The goal of this clinical trial is to learn if one course of low-dose radiation therapy (LDRT) helps as much as two courses of LDRT in people with osteoarthritis.
The main questions it aims to answer are whether pain control, joint function, and quality of life are the same with one course of LDRT.
Participants will receive LDRT and can expect to be in the study for up to 3 months.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study is being done to evaluate the degree of symptom improvement after dual-course low-dose radiation therapy (LDRT) compared to single-course LDRT in participants with osteoarthritis (OA) of the knee.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Marissa Weiss
- Numero di telefono: 608-915-1201
- Email: marissa.weiss@wisc.edu
Luoghi di studio
-
-
Wisconsin
-
Madison, Wisconsin, Stati Uniti, 53705
- University of Wisconsin - Madison
-
Contatto:
- Marissa Weiss
- Numero di telefono: 608-915-1201
- Email: marissa.weiss@wisc.edu
-
Investigatore principale:
- Jessica Schuster, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Clinical diagnosis of osteoarthritis of the knee
- Age ≥40 years at the time of consent
- Joint pain which has persisted for ≥3 months
- Completed imaging of the involved joint in the past 3 months (including MRI, CT, X-ray, or bone scan)
- Negative pregnancy test
Exclusion Criteria:
- Previous surgery to the affected joint or planned surgery to the affected joint in the next 6 months
- Previous radiation treatment targeting the affected joint. Previous radiation targeting any other body site does not exclude from participation as long as there is no clinically meaningful overlap, as determined at the discretion of the treating physician.
- Current use of prescription medications containing opioids
- Confirmed prior diagnosis of rheumatoid arthritis, pseudogout, or gout in the affected joint
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: One course of LDRT
Participants will receive one course of LDRT |
Treatments will be given twice weekly over a duration of approximately 3 weeks. |
|
Sperimentale: Two courses of LDRT
Participants will receive two courses of LDRT |
Treatments will be given twice weekly over a duration of approximately 3 weeks. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 6 months
Lasso di tempo: Baseline to 6 months
|
WOMAC is a 24 item questionnaire that evaluates pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Typically rated using a 0 to 4 scale (0 = none, mild, moderate, severe, 4 = extreme), scores range from 0 to 96 points. Higher scores indicate worse symptoms and greater functional limitation. |
Baseline to 6 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 9 months
Lasso di tempo: Baseline to 9 months
|
WOMAC is a 24 item questionnaire that evaluates pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Typically rated using a 0 to 4 scale (0 = none, mild, moderate, severe, 4 = extreme), scores range from 0 to 96 points. Higher scores indicate worse symptoms and greater functional limitation. |
Baseline to 9 months
|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 12 months
Lasso di tempo: Baseline to 12 months
|
WOMAC is a 24 item questionnaire that evaluates pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Typically rated using a 0 to 4 scale (0 = none, mild, moderate, severe, 4 = extreme), scores range from 0 to 96 points. Higher scores indicate worse symptoms and greater functional limitation. |
Baseline to 12 months
|
|
Change in WOMAC pain sub-domain score
Lasso di tempo: Baseline to 12 months
|
Pain sub-domain has 5 items that evaluate pain in patients with hip or knee osteoarthritis. Typically rated using a 0 to 4 scale (0 = none, mild, moderate, severe, 4 = extreme), scores range from 0 to 20 points. Higher scores indicate worse pain. |
Baseline to 12 months
|
|
Change in WOMAC stiffness sub-domain score
Lasso di tempo: Baseline to 12 months
|
Stiffness sub-domain has 2 items that evaluate stiffness in patients with hip or knee osteoarthritis. Typically rated using a 0 to 4 scale (0 = none, mild, moderate, severe, 4 = extreme), scores range from 0 to 8 points. Higher scores indicate worse stiffness. |
Baseline to 12 months
|
|
Change in WOMAC joint function sub-domain score
Lasso di tempo: Baseline to 12 months
|
Stiffness sub-domain has 17 items that evaluate joint function in patients with hip or knee osteoarthritis. Typically rated using a 0 to 4 scale (0 = none, mild, moderate, severe, 4 = extreme), scores range from 0 to 68 points. Higher scores indicate greater physical limitations. |
Baseline to 12 months
|
|
Incidence of adverse events
Lasso di tempo: 6 months
|
Evaluated by CTCAE, v6.0. |
6 months
|
|
Change in use of pain relievers
Lasso di tempo: Baseline to 12 months
|
Participants will self-report how much and what pain relief medication they used while on study. |
Baseline to 12 months
|
|
Change in WOMAC score in one-joint treatment compared to two-joint treatment.
Lasso di tempo: Baseline, 6 months, 9 months, 12 months
|
WOMAC is a 24 item questionnaire that evaluates pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Typically rated using a 0 to 4 scale (0 = none, mild, moderate, severe, 4 = extreme), scores range from 0 to 96 points. Higher scores indicate worse symptoms and greater functional limitation. |
Baseline, 6 months, 9 months, 12 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jessica Schuster, MD, University of Wisconsin, Madison
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-1510
- UWMSN | SMPH | Radiation Medic (Altro identificatore: UW Madison)
- Protocol Version 9/29/2026 (Altro identificatore: UW Madison)
- UW26092 (Altro identificatore: UW Madison)
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