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
- Conditions
- HealthyM17Gonarthrosis [arthrosis of knee]
- Registration Number
- DRKS00014277
- Lead Sponsor
- onza Consumer Health & Nutrition
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 45
BMI 19 - 29.9 kg / m2;
HEALTHY:
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pilot study to identify test parameters that will allow for evaluation of healthy subjects with activity related joint discomfort. Parameters to be tested are listed in the secondary outcome tab.
- Secondary Outcome Measures
Name Time Method - Joint function test<br>- Flexibility/ Range of motion knee joint (passive and active) (pre, 0h, 30 min, 2h, 24h post)<br>- Reach test (pre, 0h, 30 min, 2h, 24h post)<br>- Acute knee joint discomfort (at rest and after single-leg squat) (pre, 0h, 30min, 2h, 4h, 6h, 12h, 24h post)<br>- Maximum deterioration range of motion (passive and active)<br>- Maximum deterioration Reach test<br>- Maximum acute knee joint discomfort (at rest and after a single-leg squat)<br>- Time to first onset of pain while performing the joint function test<br>- Time to reach 5 on Likert scale or time to exhaustion while performing the joint function test<br>- Complete time of joint stress test<br>-Time to complete relief of pain post-completion of joint function test (only healthy and ArJD)<br>- Maximal pain while performing the joint stress test