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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Marissa Weiss
- 전화번호: 608-915-1201
- 이메일: marissa.weiss@wisc.edu
연구 장소
-
-
Wisconsin
-
Madison, Wisconsin, 미국, 53705
- University of Wisconsin - Madison
-
연락하다:
- Marissa Weiss
- 전화번호: 608-915-1201
- 이메일: marissa.weiss@wisc.edu
-
수석 연구원:
- Jessica Schuster, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: One course of LDRT
Participants will receive one course of LDRT |
Treatments will be given twice weekly over a duration of approximately 3 weeks. |
|
실험적: Two courses of LDRT
Participants will receive two courses of LDRT |
Treatments will be given twice weekly over a duration of approximately 3 weeks. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 6 months
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score - 9 months
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 6 months
|
Evaluated by CTCAE, v6.0. |
6 months
|
|
Change in use of pain relievers
기간: 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.
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jessica Schuster, MD, University of Wisconsin, Madison
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2026-1510
- UWMSN | SMPH | Radiation Medic (기타 식별자: UW Madison)
- Protocol Version 9/29/2026 (기타 식별자: UW Madison)
- UW26092 (기타 식별자: UW Madison)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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