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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiekontakt
- Navn: Marissa Weiss
- Telefonnummer: 608-915-1201
- E-post: marissa.weiss@wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53705
- University of Wisconsin - Madison
-
Ta kontakt med:
- Marissa Weiss
- Telefonnummer: 608-915-1201
- E-post: marissa.weiss@wisc.edu
-
Hovedetterforsker:
- Jessica Schuster, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: One course of LDRT
Participants will receive one course of LDRT |
Treatments will be given twice weekly over a duration of approximately 3 weeks. |
|
Eksperimentell: Two courses of LDRT
Participants will receive two courses of LDRT |
Treatments will be given twice weekly over a duration of approximately 3 weeks. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 6 months
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 9 months
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
|
Evaluated by CTCAE, v6.0. |
6 months
|
|
Change in use of pain relievers
Tidsramme: 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.
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jessica Schuster, MD, University of Wisconsin, Madison
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-1510
- UWMSN | SMPH | Radiation Medic (Annen identifikator: UW Madison)
- Protocol Version 9/29/2026 (Annen identifikator: UW Madison)
- UW26092 (Annen identifikator: UW Madison)
Plan for individuelle deltakerdata (IPD)
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