Clinical trial NCT03311490: The Spraino Pilot Trial
Official title: A Randomized Pilot Trial to Evaluate the Preliminary Effect and Safety of Using Spraino® to Prevent Lateral Ankle Sprains in Indoor Sports (The Spraino Pilot Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Athletes With Previous Lateral Ankle Sprain(s)
Keywords: Ankle Sprain
Prophylaxis
Indoor Sports
Ligamentous sprain
Prevention
Lead sponsor: Spraino
Sponsor class: INDUSTRY
Collaborators: name: Copenhagen University Hospital, Hvidovre
name: Aalborg University
name: Metropolitan University College
name: The Copenhagen Center for Health Technology (CACHET)
First posted: 2017-10-17
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This pilot study will establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level, with a one-year follow-up.

All recruited participants will have a history of lateral ankle sprain in the preceding 24 months prior to the initiation of the trial. Half of the included participants will receive Spraino® to prevent lateral ankle sprains (intervention group). The other half will receive no intervention ("do-as-usual" control group). Both groups will be permitted to continue or initiate any usual care of their choice, except Spraino® in the control group. Short Message Services (SMS) will be used for registration of injury and exposure.

Detailed description: The purpose of this exploratory trial (named "The Spraino Pilot Trial") is to establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level (handball, basketball, floorball and badminton) when compared to a "do-as-usual" control group.

It is a randomized controlled pilot trial (Pilot-RCT) with a two-group parallel design and blinded outcome assessment. The trial will include prospective injury and exposure registration using a Short Message Services-system (SMS-Track) throughout a 52-week follow-up period (one calendar year).

It is anticipated that 500 participants, which approximates to 250 in each group, will be enrolled in the trial. The enrollment process will cease when at least 250 participants have been allocated to the intervention group. Only athletes participating in indoor sports with a history of a lateral ankle sprain in the preceding 24 months are eligible for inclusion in the trial. The participants will be randomized (1:1 allocation ratio) using numbered lots. The randomization process will ensure stratification for gender, sports discipline and level of play.

A full trial protocol, based on the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials" (Chan et al., 2013) and the "PREPARE Trial guide" (Bandholm et al., 2017), will be published and made publicly available. The trial report will adhere to the CONSORT 2010 statement, using the extension for randomized pilot and feasibility trials.

Being an exploratory pilot trial, the study is designed with a flat outcome structure with multiple evenly valued outcome measures. Thus, no primary and secondary outcome measure hierarchy exists.

Eligibility criteria: Inclusion Criteria:

* Participant is ≥ 18 years old at commencement of trial.
* Participant can read, speak and understand Danish.
* Participant can receive and reply to texts on a cell phone using Short Message Services (SMS).
* Participant performs indoor sports (Handball, basketball, floorball orbadminton) in a sub-elite level team with ≥ 2 weekly practice sessions.
* Participant has incurred ≥ 1 lateral ankle sprain injury in the preceding 24 months.
* Participant has returned to play at commencement of the trial.

Primary outcomes:
measure: Lateral ankle sprains
timeFrame: 52 weeks
measure: First-time non-contact lateral ankle sprains
timeFrame: 52 weeks
measure: Time-loss due to first-time non-contact lateral ankle sprains
timeFrame: 52 weeks
measure: Severe first-time non-contact lateral ankle sprains
timeFrame: 52 weeks
measure: Recurrent non-contact lateral ankle sprains
timeFrame: 52 weeks
measure: Time-loss due to recurrent non-contact lateral ankle sprains
timeFrame: 52 weeks
measure: Severe recurrent non-contact lateral ankle sprains
timeFrame: 52 weeks
measure: First-time lateral ankle sprains
timeFrame: 52 weeks
measure: Time-loss due to first-time lateral ankle sprains
timeFrame: 52 weeks
measure: Severe first-time lateral ankle sprains
timeFrame: 52 weeks
measure: Recurrent lateral ankle sprains
timeFrame: 52 weeks
measure: Time-loss due to recurrent lateral ankle sprains
timeFrame: 52 weeks
measure: Severe recurrent lateral ankle sprains
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
measure: Adverse effects from using Spraino®
timeFrame: 52 weeks
measure: Fear of re-injury
timeFrame: 52 weeks
measure: Ankle pain
timeFrame: 52 weeks
Locations:
city: Aalborg
country: Denmark
facility: Physical Activity and Human Performance, Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark
city: Hvidovre
country: Denmark
facility: Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University
Study officials:
affiliation: Center for Sensory Motor Interaction, Department of Health Science and Technology, Aalborg University, Denmark
name: Filip G Lysdal, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark
name: Kristian Thorborg, PhD
role: STUDY_DIRECTOR
affiliation: Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C), Clinical Research Centre, Amager-Hvidovre Hospital, Copenhagen University, Hvidovre, Denmark
name: Thomas Q Bandholm, PhD
role: STUDY_CHAIR
affiliation: School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland
name: Eamonn Delahunt, PhD
role: STUDY_CHAIR
References:
citation: Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
citation: Bandholm T, Christensen R, Thorborg K, Treweek S, Henriksen M. Preparing for what the reporting checklists will not tell you: the PREPARE Trial guide for planning clinical research to avoid research waste. Br J Sports Med. 2017 Oct;51(20):1494-1501. doi: 10.1136/bjsports-2017-097527. Epub 2017 Sep 7. No abstract available.
citation: Lysdal FG, Bandholm T, Tolstrup JS, Clausen MB, Mann S, Petersen PB, Gronlykke TB, Kersting UG, Delahunt E, Thorborg K. Does the Spraino low-friction shoe patch prevent lateral ankle sprain injury in indoor sports? A pilot randomised controlled trial with 510 participants with previous ankle injuries. Br J Sports Med. 2021 Jan;55(2):92-98. doi: 10.1136/bjsports-2019-101767. Epub 2020 Aug 12.