|- candidate number||29562|
|- NTR Number||NTR7498|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-sep-2018|
|- Secondary IDs||EACO 99.04/18 Hogeschool van Arnhem en Nijmegen (HAN) Review Board under number EACO 99.04/18|
|- Public Title||The Effect of Compression Shorts on Footballers with Groin Pain|
|- Scientific Title||The Effect of Compression Shorts on Pain and Performance in Male Football Players with Groin Pain – A Double Blinded Randomized Controlled Trial|
|- hypothesis||We hypothesise that zoned high compression shorts significantly decrease groin pain in football players without reducing performance.|
|- Healt Condition(s) or Problem(s) studied||Inguinal Pain, Groin injury, Adductor injury, Adductor related groin pain, Pubic related groin pain, Inguinal related groin pain, Iliopsoas related groin pain|
|- Inclusion criteria||Participants are considered eligible for this trial when they are male football players with at least four weeks of groin pain, who have a minimum score of two out of ten on the Numeric Pain Rating Scale (NPRS) for their groin pain experienced during football, who compete at amateur levels, and who still play matches despite them suffering from groin pain.|
Their groin pain will classified according the Doha consensus statement on term and definitions on groin pain in athletes and at least one the four clinical entities should be found present (adductor-related groin pain, iliopsoas-related groin pain, inguinal-related groin pain, and/or pubic-related groin pain) (Weir et al. 2015).
|- Exclusion criteria||Potential participants with a clinical suspicion of hip-related groin pain or other causes of groin pain (Weir et al. 2015) will be excluded. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2018|
|- planned closingdate||1-dec-2018|
|- Target number of participants||33|
|- Interventions||All participants commence the testing procedure with completing the Dutch Hip and Groin Outcome Score questionnaire (HAGOS) (Tak et al. 2018) in order to establish a baseline measurement of the levels of groin related symptoms and problems experienced. |
All physical tests are then performed under three conditions: once wearing normal sports clothes (no compression), once wearing zoned high compression (ZHC) shorts, and once wearing non-zoned low compression (NZLC) shorts. Participants perform each of the following three tests three times under each test condition: the Copenhagen Five-second Squeeze (CS) with hand held dynamometry, the Illinois Agility Test (IAT), and a maximum ball shooting test (ST).
After the physical tests are completed under each of the three conditions, the participants are instructed to take both the ZHC-short and the NZLC-short home and wear them both for two weeks each during their football training sessions and matches. After each training and match the participants are instructed to report the following on a form; the duration of the football session in minutes, the intensity of the football session on the Borg-scale (range 6-20) (Borg 1998), the average pain of the session on the NPRS (0-10), and the comfort of the short on a numeric rating scale (NRS) (0-10). After each period of wearing one of two shorts for two weeks the participants are instructed to complete the HAGOS again. Return envelopes will be provided to each participant.
|- Primary outcome||Pain and performance. |
|- Secondary outcome||Duration of the football sessions (minutes), Intensity of the football sessions (Borg-scale), and wearing comfort of the shorts. |
|- Timepoints||Pain and performance scores are measured and taken directly after each trail of the physical tests. |
Duration and intensity of the football sessions, and the comfort of wearing the shorts should be noted immediately after the football session by the participant. This data is collected by the investigators when the data is provided to the investigators by the participants.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Roald Otten|
|- CONTACT for SCIENTIFIC QUERIES|| Roald Otten|
|- Sponsor/Initiator ||University of Bath (UK), Department of Health, MSc Sports Physiotherapy, Hogeschool van Arnhem en Nijmegen|
(Source(s) of Monetary or Material Support)
|Knap‘man® Shapewear Europe B.V., Andijk, The Netherlands|
|- Brief summary||To investigate the effects of zoned high compression shorts and non-zoned low compression shorts on pain and performance in football players with groin pain.
|- Main changes (audit trail)|
|- RECORD||18-sep-2018 - 7-okt-2018|