|- candidate number||22905|
|- NTR Number||NTR5499|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-sep-2015|
|- Secondary IDs||NL 54011.042.15 |
|- Public Title||The use of a patellar strap in children with Osgood-Schlatter disease: a pilot study of the short term effect on symptoms and sports participation.|
|- Scientific Title||The use of a patellar strap in children with Osgood-Schlatter disease: a pilot study of the short term effect on symptoms and sports participation.|
|- ACRONYM||Patellar strap in OS.|
|- hypothesis||We expect to find a positive effect on Osgood-Schlatter disease complaints as a result of the use of a patellar strap.|
|- Healt Condition(s) or Problem(s) studied||Osgood-Schlatter disease|
|- 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).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2015|
|- planned closingdate||31-dec-2016|
|- Target number of participants||40|
|- Interventions||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 subject directly scores the experienced pain on the VAS pain scale after each test. In addition, the height of the jumps of the maximal vertical jump test and the covered distances of the triple hop test will be documented for each subject.
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.
|- Primary outcome||The visual analogue scale (VAS) for pain will be used as the main study parameter in both parts of the study. The visual analogue scale consists of a pre-measured horizontal line, where the ends of the line represent the extreme limits of pain intensity. The child is asked to make a mark along the line to indicate the intensity of his/her pain. Current evidence suggests that visual analogue scales are superior for measuring pain intensity in clinical trials. Visual analogue scales
have been extensively researched and show good acceptability, responsivity and validity for children aged 8 years and older. An advantage of the visual analogue scales is the increased responsivity in pain intensity scoring due to the interval or ratio measurement continuum. We have chosen to use the Faces Pain Scale-Revised in addition to the visual analogue scale. This is especially advised for children between the ages of 8 and 12 years, as it might reduce failure rates.
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.
|- Timepoints||1. Baseline week (no intervention).|
2. Intervention week (patellar strap).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD. I. Akker-Scheek, van den|
|- CONTACT for SCIENTIFIC QUERIES||PhD. I. Akker-Scheek, van den|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|- Brief 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. |
The main 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. 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.
|- Main changes (audit trail)|
|- RECORD||24-sep-2015 - 5-jan-2016|