- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07781059
The Predictive Value of Ultrasonographic Quadriceps Muscle Parameters for Genicular Nerve Block Outcomes in Knee Osteoarthritis
The Role of Quadriceps Muscle Architecture Parameters in Predicting the Success of Genicular Nerve Block in Patients With Chronic Knee Osteoarthritis Pain
The goal of this observational study is to learn whether thigh muscle structure can help predict pain relief after a genicular nerve block in people with knee osteoarthritis. A genicular nerve block is an injection used to reduce pain signals from the knee.
The main questions are:
- Are muscle thickness, fiber length, and fiber angle linked to pain relief after the procedure?
- Are these muscle measurements linked to changes in physical function and quality of life?
Participants are adults aged 50 to 80 with long-term pain from osteoarthritis in one knee. They are already scheduled to receive a genicular nerve block as part of their regular medical care. The study does not assign participants to receive this procedure.
Before the procedure, researchers will use ultrasound to measure the vastus lateralis muscle in the thigh. Participants will also answer questions about pain, daily function, and quality of life. Researchers will repeat these assessments after 1 hour, 3 weeks, and 3 months. Pain relief will be considered successful when pain is at least half as severe as it was before the procedure.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Pendik
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Istanbul, Pendik, 터키 (Türkiye), 34899
- Marmara University Pendik Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age between 50 and 80 years
- Unilateral symptomatic knee osteoarthritis
- Chronic knee pain for at least 3 months
- Clinical and radiographic confirmation of knee osteoarthritis
- Kellgren-Lawrence grade 3 or 4 knee osteoarthritis
- Inadequate clinical response despite analgesic therapy and physical therapy
- Clinical indication for genicular nerve block
Exclusion Criteria:
- History of surgery involving the knee region
- Bilateral symptomatic knee osteoarthritis
- Intra-articular knee injection within the previous 3 months
- Systemic disease that could affect study assessments
- Systemic or local infection
- Coagulation disorder
- Failure to provide written informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Patients With Chronic Knee Osteoarthritis Undergoing Ultrasound- Guided Genicular Nerve Block
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Ultrasound-guided genicular nerve block targeting the superomedial, superolateral, and inferomedial genicular nerves was performed as part of routine clinical management for chronic knee osteoarthritis.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Pain Intensity Assessed by the Numeric Rating Scale (NRS)
기간: Baseline , 3 weeks, and 3 months
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Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Changes from baseline will be evaluated following ultrasound-guided genicular nerve block.
Lower scores indicate lower pain intensity.
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Baseline , 3 weeks, and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Baseline Vastus Lateralis Muscle Thickness
기간: Baseline
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Vastus lateralis muscle thickness assessed by ultrasound and recorded in millimeters (mm).
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Baseline
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Baseline Vastus Lateralis Pennation Angle
기간: Baseline
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Description: Vastus lateralis pennation angle assessed by ultrasound and recorded in degrees (°).
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Baseline
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Baseline Vastus Lateralis Fascicle Length
기간: Baseline
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Description: Vastus lateralis fascicle length assessed by ultrasound and recorded in millimeters (mm).
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Baseline
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Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
기간: Baseline, 3 weeks, and 3 months after the procedure
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Description: Pain, stiffness, and physical function related to knee osteoarthritis will be assessed using the 24-item WOMAC questionnaire.
The total score ranges from 0 to 96, with higher scores indicating greater pain, stiffness, and functional impairment.
Changes from baseline will be evaluated following ultrasound-guided genicular nerve block.
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Baseline, 3 weeks, and 3 months after the procedure
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Change in Health-Related Quality of Life Assessed by the EQ-5D
기간: Baseline, 3 weeks, and 3 months after the procedure
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Description: Health-related quality of life will be assessed using the EQ-5D questionnaire.
Responses will be converted into an EQ-5D index score, where higher scores indicate better health status.
A score of 1 represents full health, 0 represents a health state equivalent to death, and negative scores represent health states considered worse than death.
Changes from baseline will be evaluated following ultrasound-guided genicular nerve block.
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Baseline, 3 weeks, and 3 months after the procedure
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
키워드
기타 연구 ID 번호
- 09.2019.1051
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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