Primary objective:The purpose of this study is to evaluate the short term effect of a patellar strap on symptoms and sports participation in children with Osgood-Schlatter disease.Secondary objective: The second objective of this study is to…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
First part of the study:
VAS pain score after ten single leg decline squats (for each condition).
Second part op the study:
The difference in the average VAS pain score during sports between the baseline
week and the intervention week.
Secondary outcome
First part of the study:
- VAS pain score after the maximal vertical jump test.
- VAS pain score after the triple hop test.
- The height in meters of the highest jump during the maximal vertical jump
test.
- The distance in meters that is covered by three jumps during the triple hop
test.
Second part of the study:
- The difference in the average VAS pain score the two hours after sports
between the baseline week and the intervention week.
- The difference in the average VAS pain score the morning after sports between
the baseline week and the intervention week.
Background summary
Osgood-Schlatter disease is a traction apophysitis of the proximal tibia due to
repetitive strain on the secondary ossification center of the tibial
tuberosity. This overuse injury is prevalent in growing children, especially
boys, who are actively engaged in sports. Osgood-Schlatter disease can
negatively influence the course of a child*s sports career. Orthosis like a
patellar strap are sometimes used to reduce the pain in this condition, so
children can continue to be active in sports. However, very little scientific
evidence for a positive effect on symptoms and sports participation is
available yet.
Study objective
Primary objective:
The purpose of this study is to evaluate the short term effect of a patellar
strap on symptoms and sports participation in children with Osgood-Schlatter
disease.
Secondary objective:
The second objective of this study is to determine the relationship between the
effectiveness of a patellar strap and injury-specific, sports-specific and
personal factors.
Study design
This study is divided in two parts. Subjects who participate in the first part
of the study are asked to participate in de second part also.
The first part (controlled situation) is a randomized controlled crossover
experiment. The subjects serve as their own control by performing three
functional tests in three different conditions (in a randomized order).
The three conditions are:
1. Patellar strap
2. Placebo tape (kinesiotape)
3. Control condition (no patellar strap/no placebo tape)
The three functional tests are:
1. Single leg decline squats
2. Maximal vertical jump test
3. Triple hop test.
All subjects will execute all tests under all conditions during one session.
The second part (sport specific situation) is a cohort study. All subjects will
have a baseline week (no intervention) and an intervention week (patellar
strap), in which they train and compete in their own environment. They will be
asked to document the following in a 2-week log: the amount of pain during and
after every training/competition and the duration and number of
training/competitions.
Intervention
In first part, participants perform three functional tests (single leg decline
squat, maximal vertical jump test, triple hop test) in three different
conditions (patellar strap, placebo tape, control condition).
In the second part, participants train and compete in their own environment and
fill out a log during a baseline week (no intervention) and an intervention
week (patellar strap).
Study burden and risks
The research question can only be answered by studying children with
Osgood-Schlatter disease. The outcome of the study outweighs the burden for the
children. The estimated duration of the first part of the study is 90 minutes;
of the second part 30 minutes. The risks are negligible, as all tests are also
performed during physical examination when children visit the outpatient clinic
and during usual rehabilitation sessions or sports activities. Knowledge gained
with this study can help physicians and physiotherapists to advise children
with Osgood-Schlatter disease and their parents regarding the use of a patellar
strap.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
1. Age 8-15 years.
2. Diagnosis of Osgood-Schlatter disease based on clinical symptoms in combination with redness, prominence and pain at palpation of the tibial tuberosity.
3. Duration of symptoms for over 4 weeks.
4. SOS score < 80.
Exclusion criteria
1. Signs or symptoms of other knee pathologies.
2. Other injury to the affected leg.
3. Chronic joint disease(s).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54011.042.15 |
| OMON | NL-OMON21775 |