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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: Marissa Weiss
- Telefonnummer: 608-915-1201
- E-Mail: marissa.weiss@wisc.edu
Studienorte
-
-
Wisconsin
-
Madison, Wisconsin, Vereinigte Staaten, 53705
- University of Wisconsin - Madison
-
Kontakt:
- Marissa Weiss
- Telefonnummer: 608-915-1201
- E-Mail: marissa.weiss@wisc.edu
-
Hauptermittler:
- Jessica Schuster, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: One course of LDRT
Participants will receive one course of LDRT |
Treatments will be given twice weekly over a duration of approximately 3 weeks. |
|
Experimental: Two courses of LDRT
Participants will receive two courses of LDRT |
Treatments will be given twice weekly over a duration of approximately 3 weeks. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 6 months
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 9 months
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 months
|
Evaluated by CTCAE, v6.0. |
6 months
|
|
Change in use of pain relievers
Zeitfenster: 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.
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Jessica Schuster, MD, University of Wisconsin, Madison
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-1510
- UWMSN | SMPH | Radiation Medic (Andere Kennung: UW Madison)
- Protocol Version 9/29/2026 (Andere Kennung: UW Madison)
- UW26092 (Andere Kennung: UW Madison)
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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