|- candidate number||21097|
|- NTR Number||NTR4991|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-dec-2014|
|- Secondary IDs||NL 51658.042.14 |
|- Public Title||The use of a patellar strap in athletes with a jumperís knee: A pilot study on the effect on symptoms, proprioception and tendon structure|
|- Scientific Title||The TOPPRO 2 study: Tendinopathy of Pain Relieving Orthoses 2
|- ACRONYM||TOPPRO 2|
|- hypothesis||A patellar strap reduces pain, has a positive effect on knee joint proprioception and tendon structure. |
|- Healt Condition(s) or Problem(s) studied||Jumper's knee, Patellar tendinopathy|
|- Inclusion criteria||- Age 18-50 years|
- Current symptoms of knee pain in the patellar tendon or its patellar or tibial insertion in connection with training and competition in one or both knees
- Duration of symptoms for over three months (to exclude acute inflammatory tendon problems and de novo partial ruptures).
- Palpation tenderness at the corresponding painful area.
- VISA-P score < 80.
- Participating athlete
- No use of a patellar strap during sports in the week prior to the study.
|- Exclusion criteria||- Signs or symptoms of other (co-)existing knee pathologies|
- Use of drugs with a putative effect on patellar tendinopathy in the last year on daily basis or painkillers
- Neurologic disorders which might influence pain and propriocepsis
- Knee surgery or injection therapy with corticosteroids in the last preceding three months
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2015|
|- planned closingdate||1-jan-2016|
|- Target number of participants||25|
|- Interventions||Subjects visit the center for sports medicine two times.
During the first visit the patellar tendons of the participants are scanned using UTC and all subjects perform three functional tests (10 single leg decline squats, maximal vertical jump test and a triple hop test) and a proprioception test in two different conditions. The two conditions are: with patellar strap and a control condition. The order of the conditions is balanced between subjects. Directly after each test, the participant scores on a VAS pain scale the experienced pain during the test. Furthermore, the maximal vertical jump height and the distance covered in the triple hop test are documented.
After this visit, subjects wear the Genupoint patellar strap during sports for one week.
During the second visit (after one week of athletic performance with strap) the patellar tendons are again scanned using UTC. In addition participants fill out a questionnaire about the wearing comfort of the strap.
|- Primary outcome||The difference in Visual Analogue Scale (VAS) for pain after ten single leg decline squats between the patellar strap and control condition will be used as the main study outcome in this study.
|- Secondary outcome||The difference in VAS pain score between both conditions (control and strap) during the jump test and the triple hop test are secondary outcomes, as well as the height (m) and distance (m) measured during these tests. In addition, the difference in proprioception (Joint Position Sense expressed by the deviation in millimeters from a marker) between both conditions is also a secondary outcome measure.
The difference in percentage of echotypes 1,2,3 and 4 between the follow up UTC measurement (effect of a patellar strap) compared to the baseline UTC measurement (no patellar strap) are also secondary outcomes. Finally, the comfort grade (0-10) of wearing the Genupoint patellar strap is a secondary outcome parameter. |
|- Timepoints||1. Baseline (after one control week, with athletic performance without orthosis)|
2. After one week of athletic performance with the Genupoint patellar strap
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Drs. A.J. Vries, de|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A.J. Vries, de|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Bauerfeind Benelux B.V.|
|- Brief summary||Patellar tendinopathy (PT) is a common painful overuse injury which often interferes with the sports career of jumping athletes. Orthoses like a patellar strap are commonly used to reduce pain and to remain active in sports. A recent study (de Vries et al, in preperation) showed that pain can decrease with the use of a patellar strap, but it is unknown if this positive effect can be found with another type of strap and what the effect on proprioception and tendon structure is. Furthermore, the relationship between the effectiveness of the use of a patellar strap and tendon structure is unclear. |
|- Main changes (audit trail)|
|- RECORD||1-dec-2014 - 31-mrt-2015|