Trial document




This trial has been registered retrospectively.
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  DRKS00014277

Trial Description

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Title

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

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Trial Acronym

BTS1100/17

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URL of the Trial

http:///

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Brief Summary in Lay Language

The aim of this study is to develop a joint function test that will allow selection of healthy subjects who have activity related joint discomfort. For this purpose, 3 groups will be examined: healthy subjects, healthy subjects with activity related joint discomfort, and osteoarthritis subjects. As endpoints parameters like repetition until occurrence of a defined discomfort / pain, flexibility, and discomfort after burden will be evaluated at defined time points. To test reliability the test will be repeated after 14 days

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Brief Summary in Scientific Language

A 3-arm pilot study will investigate the suitability and reliability of a joint function test. For this purpose, 3 groups will be examined: healthy subjects, healthy subjects with activity related joint discomfort, and osteoarthritis subjects.The joint function test will be done at baseline and at day 14 to confirm test-retest reliability.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00014277
  •   2018/07/13
  •   [---]*
  •   no
  •   Approved
  •   F-2017-088, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Healthy
  •   M17 -  Gonarthrosis [arthrosis of knee]
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Interventions/Observational Groups

  •   Healthy subjects performing the joint function test for a maximum of 10 minutes or reaching joint discomfort of at least 5 on a 11-point Liker scale. The test will be performed at screening , visit 1 and visit 2 with two weeks between the tests. At visit 1 and 2, endpoints will be assessed at defined time points over a time interval of 24h (see secondary endpoints).
  •   Healthy subjects with activity-related join discomfort performing the joint function test for a maximum of 10 min or until reaching joint discomfort of at least 5 on a 11-point Liker scale. The test will be performed at screening, visit 1 and visit 2 with two weeks between the tests. At visit 1 and 2, endpoints will be assessed at defined time points over a time interval of 24h (see secondary endpoints).
  •   Patients with mild-to-moderate osteoarthritis performing the joint function test for a maximum of 10 minutes or reaching joint discomfort of at least 5 on a 11-point Liker scale. The test will be performed at screening, visit 1 and visit 2 with two weeks between the tests. At visit 1 and 2, endpoints will be assessed at defined time points over a time interval of 24h (see secondary endpoints).
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

- Joint function test
- Flexibility/ Range of motion knee joint (passive and active) (pre, 0h, 30 min, 2h, 24h post)
- Reach test (pre, 0h, 30 min, 2h, 24h post)
- Acute knee joint discomfort (at rest and after single-leg squat) (pre, 0h, 30min, 2h, 4h, 6h, 12h, 24h post)
- Maximum deterioration range of motion (passive and active)
- Maximum deterioration Reach test
- Maximum acute knee joint discomfort (at rest and after a single-leg squat)
- Time to first onset of pain while performing the joint function test
- Time to reach 5 on Likert scale or time to exhaustion while performing the joint function test
- Complete time of joint stress test
-Time to complete relief of pain post-completion of joint function test (only healthy and ArJD)
- Maximal pain while performing the joint stress test

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/02/05
  •   45
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

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.

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Exclusion Criteria

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.

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Addresses

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    • Lonza Consumer Health & Nutrition
    • Mr.  Dr.  James  Lugo 
    • 5451 Industrial Way
    • 94510  Benicia
    • United States
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    • Lonza Consumer Health & Nutrition
    • Mr.  Dr.  James  Lugo 
    • 5451 Industrial Way
    • 94510  Benicia
    • United States
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    • BioTeSys GmbH
    • Ms.  Antje  Micka 
    • Schelztorstr. 54-56
    • 73728  Esslingen
    • Germany
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Sources of Monetary or Material Support

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    • Lonza Consumer Health & Nutrition
    • Mr.  Dr.  James  Lugo 
    • 5451 Industrial Way
    • 94510  Benicia
    • United States
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Status

  •   Recruiting complete, follow-up complete
  •   2018/08/01
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.