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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Marissa Weiss
- 電話番号：608-915-1201
- メール：marissa.weiss@wisc.edu
研究場所
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53705
- University of Wisconsin - Madison
-
コンタクト：
- Marissa Weiss
- 電話番号：608-915-1201
- メール：marissa.weiss@wisc.edu
-
主任研究者：
- Jessica Schuster, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：One course of LDRT
Participants will receive one course of LDRT |
Treatments will be given twice weekly over a duration of approximately 3 weeks. |
|
実験的：Two courses of LDRT
Participants will receive two courses of LDRT |
Treatments will be given twice weekly over a duration of approximately 3 weeks. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 6 months
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 9 months
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：6 months
|
Evaluated by CTCAE, v6.0. |
6 months
|
|
Change in use of pain relievers
時間枠：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.
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Jessica Schuster, MD、University of Wisconsin, Madison
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026-1510
- UWMSN | SMPH | Radiation Medic (その他の識別子：UW Madison)
- Protocol Version 9/29/2026 (その他の識別子：UW Madison)
- UW26092 (その他の識別子：UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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