2023-510079-74-00招募中3 期
Efficacy of ultrasound-monitored meniscal wall betamethasone infiltration on pain in relation to degenerative meniscal injury: a randomized, double-blind, placebo-controlled multicenter trial. MINUS (Meniscal INfiltration of corticosteroid guided with Ultra Sonography)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 5
- 主要终点
- The primary endpoint is the change in meniscal pain measured using the Visual Analog Scale (VAS) between the initial visit and the 1-month follow-up visit
研究概览
简要总结
The main objective is to evaluate the efficacy of ultrasound-guided meniscal wall infiltration of betamethasone versus ultrasound-guided meniscal wall infiltration of placebo, at 1 month, on meniscal pain in the treatment of meniscal pain of degenerative origin in adult.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient aged ≥ 18 years
- •Localized knee pain with tenderness over the medial or lateral joint space reproduced on clinical examination
- •Pain assessed with a VAS score > 4/10 despite first-line medical treatment including the use of tier I or II analgesics or NSAIDs
- •An MRI of the knee performed in the 6 months preceding the operation as part of the pre-treatment assessment
- •Medial or lateral degenerative meniscal lesion on MRI consistent with pain, confirmed by an investigating physician
- •Affiliation to the Social Security
- •Free and informed consent signed by the patient
排除标准
- •Patient under 18 years of age
- •History of corticosteroid injection in the knee concerned in the 3 months preceding inclusion
- •Use of NSAIDs and oral corticosteroids during the 48 hours preceding inclusion
- •Use of tier 3 analgesics for gonalgia in the 3 months prior to inclusion
- •Episodes of knee instability or true locking
- •Radiographic gonarthrosis with a Kellgren Lawrence stage > 1 authenticated on radiographic images taken within the last 6 months.
- •Known inflammatory rheumatism
- •Fibromyalgia as determined by the clinical investigator
- •Pregnancy and breastfeeding in progress
- •Contraindication to the use of injectable corticosteroids: septic arthritis, skin lesions at the injection site, severe coagulation disorders, hypersensitivity to one of the excipients
- •Contraindication to the use of systemic corticosteroids: acute infection, untreated and uncontrolled chronic infection, psychiatric or ophthalmological pathologies, unbalanced diabetes, uncontrolled hypertension
- •Patient under curatorship or guardianship
- •Contraindication to the use of lidocaine: known hypersensitivity to lidocaine hydrochloride, to local anaesthetics with an amide bond or to one of the excipients, patients with recurrent porphyrias
- •Patients on anticoagulants
- •Inability to speak, read or write French fluently
- •Patient deprived of liberty
- •Patients with psychiatric pathology
- •Patient who has had an MRI showing an unstable meniscal lesion confirmed by the coordinating radiologist: complete vertical tear of more than 10 mm in length, capsulomeniscal disinsertion of more than 10 mm in length, complex tear, T2 hypersignal tear of liquid type with passage of liquid testifying to the spreading of the edges, tear with displaced meniscal fragment, lesion of a posterior meniscal brake, lesion of the meniscotibial or meniscofemoral attachment
- •Patient with an MRI showing recent ligament injury(ies) (cruciate ligaments and/or collateral ligaments)
- •History of knee trauma less than 3 months
- •History of arthroscopy or open surgery of the involved knee
结局指标
主要结局
The primary endpoint is the change in meniscal pain measured using the Visual Analog Scale (VAS) between the initial visit and the 1-month follow-up visit
The primary endpoint is the change in meniscal pain measured using the Visual Analog Scale (VAS) between the initial visit and the 1-month follow-up visit
次要结局
- the evolution of the VAS score between the initial visit and the 3-month follow-up visit
- the evolution of the score of each dimension (Pain, Symptoms, Activities of daily living, Sport and recreation function, and Knee-related qualities of life) of the algo-functional scale KOOS (appendix 1) between the initial visit and the 1-month follow-up visit
- the evolution of each dimension of the algo-functional scale KOOS score between the initial visit and the 3-month follow-up visit
- the occurrence of adverse events (AEs) and serious AEs (SAEs) up to 3 months of follow-up
- Analgesic response is defined as a at least 50% reduction in pain (measured using the VAS scale) between the initial visit and the 1-month follow-up visit.
研究者
BELLOC
Scientific
Centre Hospitalier Universitaire De Toulouse
研究点 (5)
Loading locations...
相似试验
进行中（未招募）
1 期
Betamethasone meniscal infiltration under ultrasound control: a randomized, double-blind, placebo-controlled multicenter trial.meniscal pain of degenerative originCTIS2023-510079-74-00Centre Hospitalier Universitaire De Toulouse152
招募中
不适用
Meniscal extrusion in ultrasound as a new diagnostic tool for evaluation of medial and lateral meniscus functiohealthy subjectsDRKS00010963Klinikum rechts Isar, Abteilung für Sportorthopädie90
暂停
不适用
Efficacy of ultrasound-guided supra-inguinal fascia iliaca block for total hip replacementTotal hip replacementJPRN-UMIN000033483Showa university hospital15
招募中
不适用
Efficacy of shoulder injections in shoulder joint pain due to frozen shoulderCTRI/2017/06/008919Department of Radiodiagnosis98
尚未招募
不适用
low back pain and buttock paiCTRI/2021/05/033690IPGMER and SSKM hospital