Direct comparison of intra-articular saline injections with an education plus exercise program for treatment of knee osteoarthritis symptoms: A randomised, open label, controlled, evidence based trial - DISCO

The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark0 个研究点目标入组 200 人开始时间: 2019年4月16日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•- Age =50 years.
•- Body Mass index = 35
•- A clinical diagnosis of tibiofemoral OA in the target knee according to the American College of Rheumatology.
•- Average knee pain in the last week during weight bearing activities of at least 4 on a 0 to 10 points scale (0=no pain; 10=worst possible pain).
•- Verification of clinical diagnosis by definite tibiofemoral OA on posterior-anterior weight bearing semi-flexed knee radiographs with severity equivalent to Kellgren and Lawrence grade 2 or more.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•- Intra-articular treatments of any kind of either knee 3 months before inclusion
•- Scheduled surgery during study participation
•- Knee joint fluid aspiration within 3 month of baseline visit
•- Participation in exercise therapy within 3 months of baseline visit
•- Evidence of other inflammatory joint disease (e.g. rheumatoid arthritis or gout)
•- History of knee surgery within 12 months
•- History of arthroplasty in the target knee
•- Use of oral glucocorticoids
•- Use of synthetic or non-synthetic opioids
•- Other musculoskeletal, neurological, medical conditions precluding participation in exercise
•- Contraindications to intra-articular injections, such as wounds or skin rash over injection site.
•- Contraindications to exercise
•- Planning to start other treatment for knee OA in the study participation period
•- Regional pain syndromes
•- Generalised pain syndromes such as fibromyalgia
•- Lumbar or cervical nerve root compression syndromes
•- Pregnancy or insufficient anti-conception therapy for female fertile patients
•- Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as large knee joint effusion, uncontrolled diabetes, psychiatric disorders, or opiate dependency.

发起方

The Parker Institute, Bispebjerg and Frederiksberg Hospital, The Capital Region of Denmark