Pilot study to evaluate a joint stress test to induce joint discomfort in healthy subjects with activity-related joint discomfort – a prospective 3-arm study with healthy subjects and subjects with mild-to-moderate osteoarthritis as control group - BTS1100/17

onza Consumer Health & Nutrition0 个研究点目标入组 45 人开始时间: 2018年7月13日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•BMI 19 - 29.9 kg / m2;
•Performing joint-bearing sports (e.g.soccer, handball, etc.) for at least 2 times per week;
•Do not experience knee joint pain > 2 when performing the joint function test;
•HEALTHY SUBJECTS WITH ACTIVITY RELATED JOINT DISCOMFORT:
•Performing joint-bearing sports (e.g.soccer, handball, etc.) for at least 2 times per week;
•Having knee joint pain of at least 5 on a 11-point Likert scale when performing the joint function test;
•OSTEOARTHRITIS SUBJECTS:
•Knee joint problems in everyday life and under load
•Diagnosed osteoarthrosis: Kellgren 2 or 3
•Ability to perform the joint function test.
•Reversible knee-joint discomfort during or immediately after physical activity over a period of at least 3 months.

•Joint replacement of the knee, Planned surgical intevention during the next 2 months Intra-articular therapy within the last 3 months, Severe cardiovascular disease or other comorbidities (e.g., myocardial infarction, stroke, diabetes, etc.), Subjects not willing to abstain from intake of analgesic medication 24 hours prior to and during visits, Participation in a clinical study with an investigational product within 30 days before screening, Female patients that are pregnant or nursing, Abuse of drugs or alcohol, Known alcohol abuse or drug abuse.
•Additional criteria for healthy persons and subjects with activity-related joint discomfort:
•Diagnosed osteoarthrosis, rheumatism or other joint disorder, Acute knee pain at rest or during daily life activities, Acute knee injury or previous serious injury unless cured and if not more than 2 years ago.
•Additional criteria for osteoarthrosis patients:
•Rheumatism or other joint disorder, Activated gonarthrosis or acute injury.

发起方

onza Consumer Health & Nutrition