Foot orthoses for the prevention of lower limb overuse injuries in naval recruits: study protocol for a randomised controlled trial

Journal of Foot and Ankle Research

Hylton B. Menz¹  Karl B. Landorf¹  Shannon E. Munteanu¹  George S. Murley¹  Daniel R. Bonanno¹ 

[1] Lower Extremity and Gait Studies Program, College of Science, Health and Engineering, La Trobe University, Victoria 3086, Australia

关键词: Military personnel;    Leg injuries;    Orthotic devices;    Prevention;    Randomized controlled trial;   

Others  :  1225203
DOI  :  10.1186/s13047-015-0109-2

 received in 2015-05-20, accepted in 2015-09-03,  发布年份 2015

【 摘 要 】

Background

Foot orthoses are frequently used for the prevention of lower limb overuse injuries but evidence for their effectiveness is limited. The primary aim of this study is to determine if prefabricated foot orthoses reduce the incidence of lower limb overuse injuries in naval recruits undertaking 11 weeks of basic training.

Methods

This study is a participant and assessor blinded, parallel-group, randomised controlled trial. The trial will recruit participants undertaking 11 weeks of basic training at the Royal Australian Navy Recruit School, Cerberus, Victoria, Australia. Participants will be randomised to a control group (flat insole) or an intervention group (prefabricated foot orthosis). Over the 11 weeks of basic training, participants will document the presence and location of pain in weekly self-report diaries. The end-point for each participant will be the completion of 11 weeks of basic training. The primary outcome measure will be the combined incidence of four lower limb injuries (medial tibial stress syndrome, patellofemoral pain, Achilles tendinopathy, and plantar fasciitis/plantar heel pain) which are common among defence members. Secondary outcome measures include: (i) overall incidence of lower limb pain, (ii) severity of lower limb pain, (iii) time to injury, (iv) time to drop-out due to injury, (v) adverse events, (vi) number of lost training days, (vii) shoe comfort, and (viii) general health status. Data will be analysed using the intention-to-treat principle.

Discussion

This randomised controlled trial will evaluate the effectiveness of prefabricated foot orthoses for the prevention of common lower limb overuse injuries in naval recruits.

Trial registration

Australian New Zealand Clinical Trials Registry: ACTRN12615000024549.

【 授权许可】

   
2015 Bonanno et al.

【 图 表 】

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【 参考文献 】

• [1]Lopes AD, Hespanhol LC, Yeung SS, Costa L. What are the Main Running-Related Musculoskeletal Injuries? Sports Med. 2012; 42(10):891-905.
• [2]Franklyn-Miller A, Wilson C, Bilzon J, McCrory P. Foot orthoses in the prevention of injury in initial military training: a randomized controlled trial. Am J Sports Med. 2011; 39(1):30-7.
• [3]van Gent RN, Siem D, van Middelkoop M, van Os AG, Bierma-Zeinstra SMA, Koes BW. Incidence and determinants of lower extremity running injuries in long distance runners: a systematic review. Br J Sports Med. 2007; 41(8):469-80.
• [4]Kaufman KR, Brodine S, Shaffer R. Military training-related injuries: Surveillance, research, and prevention. Am J Prev Med. 2000; 18(3, Supplement 1):54-63.
• [5]Sherrard J, Lenné M, Cassell E, Stokes M, Ozanne-Smith J. Injury prevention during physical activity in the Australian Defence Force. J Sci Med Sport. 2004; 7(1):106-17.
• [6]Yeung SS, Yeung EW, Gillespie LD. Interventions for preventing lower limb soft-tissue running injuries. Cochrane Database Syst Rev. 2011;7.
• [7]Landorf KB, Keenan AM, Rushworth RL. Foot orthosis prescription habits of Australian and New Zealand podiatric physicians. J Am Podiatr Med Assoc. 2001; 91(4):174-83.
• [8]Barton CJ, Munteanu SE, Menz HB, Crossley KM. The efficacy of foot orthoses in the treatment of individuals with patellofemoral pain syndrome: a systematic review. Sports Med. 2010; 40(5):377-95.
• [9]Collins N, Bisset L, McPoil T, Vicenzino B. Foot orthoses in lower limb overuse conditions: a systematic review and meta-analysis. Foot Ankle Int. 2007; 28(3):396-412.
• [10]Hawke F, Burns J, Radford JA, Du Toit V. Custom-made foot orthoses for the treatment of foot pain. Cochrane Database Syst Rev. 2008; 3: Article ID CD006801
• [11]Larsen K, Weidich F, Leboeuf-Yde C. Can custom-made biomechanic shoe orthoses prevent problems in the back and lower extremities? A randomized, controlled intervention trial of 146 military conscripts. J Manipulative Physiol Ther. 2002; 25(5):326-31.
• [12]Milgrom C, Giladi M, Kashtan H, Simkin A, Chisin R, Margulies J, Steinberg R, Aharonson Z, Stein M. A Prospective Study of the Effect of a Shock-Absorbing Orthotic Device on the Incidence of Stress Fractures in Military Recruits. Foot Ankle Int. 1985; 6(2):101-4.
• [13]Mills K, Blanch P, Chapman AR, McPoil TG, Vicenzino B. Foot orthoses and gait: a systematic review and meta-analysis of literature pertaining to potential mechanisms. Br J Sports Med. 2010; 44(14):1035-46.
• [14]Landorf KB, Keenan AM. Do foot orthoses prevent injury? In: Evidence-based Sports Medicine. 2nd ed. MacAuley D, Best TM, editors. Blackwell Publishing, Malden, Massachusetts; 2007: p.73-92.
• [15]Schulz K, Altman D, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340:c332.
• [16]Moher D, Hopewell S, Schulz K, Montori V, Gøtzsche P, Devereaux P, Elbourne D, Egger M, Altman D. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340:c869.
• [17]National Statement on Ethical Conduct in Human Research 2007 (Updated May 2015). The National Health and Medical Research Council, the Australian Research Council and the Australian Vice-Chancellors’ Committee. Commonwealth of Australia, Canberra.
• [18]Ethical principles for medical research involving human subjects [http://www.wma.net/en/30publications/10policies/b3/] Accessed 7 September 2015.
• [19]Defence jobs recruitment centre [https://www.defencejobs.gov.au/recruitmentcentre/default.aspx] Accessed 7 September 2015.
• [20]Leger LA, Mercier D, Gadoury C, Lambert J. The multistage 20 m shuttle run test for aerobic fitness. J Sports Sci. 1988; 6(2):93-101.
• [21]Cotchett MP, Landorf KB, Munteanu SE, Raspovic A. Effectiveness of trigger point dry needling for plantar heel pain: study protocol for a randomised controlled trial. J Foot Ankle Res. 2010; 4(5):1-10.
• [22]Barton CJ, Bonanno D, Levinger P, Menz HB. Foot and ankle characteristics in patellofemoral pain syndrome: a case control and reliability study. J Orthop Sports Phys Ther. 2010; 40(5):286-96.
• [23]Yates B, White S. The Incidence and Risk Factors in the Development of Medial Tibial Stress Syndrome Among Naval Recruits. Am J Sports Med. 2004; 32(3):772-80.
• [24]Brushøj C, Larsen K, Albrecht-Beste E, Nielsen MB, Løye F, Hölmich P. Prevention of Overuse Injuries by a Concurrent Exercise Program in Subjects Exposed to an Increase in Training Load: A Randomized Controlled Trial of 1020 Army Recruits. Am J Sports Med. 2008; 36(4):663-70.
• [25]Finestone A, Novack V, Farfel A, Berg A, Amir H, Milgrom C. A Prospective Study of the Effect of Foot Orthoses Composition and Fabrication on Comfort and the Incidence of Overuse Injuries. Foot Ankle Int. 2004; 25(7):462-6.
• [26]Finestone A, Giladi M, Elad H, Salmon A, Mendelson S, Eldad A, Milgrom C. Prevention of stress fractures using custom biomechanical shoe orthoses. Clin Orthop Relat Res. 1999; 360:182-90.
• [27]Redmond AC, Crosbie J, Ouvrier RA. Development and validation of a novel rating system for scoring standing foot posture: the Foot Posture Index. Clin Biomech (Bristol, Avon). 2006; 21(1):89-98.
• [28]Bennell K, Talbot R, Wajswelner H, Techovanich W, Kelly D, Hall AJ. Intra-rater and inter-rater reliability of a weight-bearing lunge measure of ankle dorsiflexion. Aust J Physiother. 1998; 44(3):175-80.
• [29]Munteanu SE, Strawhorn AB, Landorf KB, Bird AR, Murley GS. A weightbearing technique for the measurement of ankle joint dorsiflexion with the knee extended is reliable. J Sci Med Sport. 2009; 12(1):54-9.
• [30]Perrott MA, Pizzari T, Opar M, Cook J. Development of Clinical Rating Criteria for Tests of Lumbopelvic Stability. Rehabil Res Pract. 2012; 2012:1-7.
• [31]Ware J, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996; 34(3):220-33.
• [32]Besson H, Brage S, Jakes RW, Ekelund U, Wareham NJ. Estimating physical activity energy expenditure, sedentary time, and physical activity intensity by self-report in adults. Am J Clin Nutr. 2010; 91(1):106-14.
• [33]Lacey RJ, Lewis M, Jordan K, Jinks C, Sim J. Interrater Reliability of Scoring of Pain Drawings in a Self-Report Health Survey. Spine. 2005; 30(16):E455-8.
• [34]Garrow AP, Silman AJ, Macfarlane GJ. The Cheshire Foot Pain and Disability Survey: a population survey assessing prevalence and associations. Pain. 2004; 110(1–2):378-84.
• [35]Chatterton BD, Muller S, Thomas MJ, Menz HB, Rome K, Roddy E. Inter and intra-rater repeatability of the scoring of foot pain drawings. J Foot Ankle Res. 2013; 6(44):1-7.
• [36]Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. Br J Sports Med. 2009; 43(3):169-71.
• [37]de Vos RJ, Weir A, van Schie HM, Bierma-Zeinstra SMA, Verhaar JAN, Weinans H, Tol JL. Platelet-rich plasma injection for chronic achilles tendinopathy: A randomized controlled trial. JAMA. 2010; 303(2):144-9.
• [38]Bonanno DR, Landorf KB, Menz HB. Pressure-relieving properties of various shoe inserts in older people with plantar heel pain. Gait Posture. 2010; 33(3):385-9.
• [39]Revill SI, Robinson JO, Rosen M, Hogg MIJ. The reliability of a linear analogue for evaluating pain. Anaesthesia. 1976; 31(9):1191-8.
• [40]Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983; 17(1):45-56.
• [41]Munteanu SE, Scott LA, Bonanno DR, Landorf KB, Pizzari T, Cook JL, Menz HB. Effectiveness of customised foot orthoses for Achilles tendinopathy: a randomised controlled trial. Br J Sports Med. 2014.
• [42]Keech AC, Wonders SM, Cook DI, Gebski VJ. Balancing the outcomes: reporting adverse events. Med J Aust. 2004; 181(4):215-8.
• [43]Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, Wood AM, Carpenter JR. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ (Clinical research ed). 2009; 338:b2393.
• [44]Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001; 323(7321):1123-4.
• [45]Landorf KB. Clinical trials: the good, the bad and the ugly. In: Research methods in health: foundations for evidence-based practice. 2nd ed. Liamputtong P, editor. Oxford University Press, Melbourne; 2013: p.234-48.
• [46]Torgerson DJ, Torgerson CJ. Designing randomised trials in health education and the social sciences: an introduction. Houndmills, Basingstoke, Hampshire, Palgrave MacMillan; 2008.
• [47]Landorf KB, Keenan AM, Herbert RD. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Arch Intern Med. 2006; 166(12):1305-10.
• [48]Spink MJ, Menz HB, Fotoohabadi MR, Wee E, Landorf KB, Hill KD, Lord SR. Effectiveness of a multifaceted podiatry intervention to prevent falls in community dwelling older people with disabling foot pain: randomised controlled trial. BMJ. 2011; 342:d3411.
• [49]Bonanno DR, Landorf KB, Murley GS, Menz HB. Selecting control interventions for use in orthotic trials: the methodological benefits of sham orthoses. Contemp Clin Trials. 2015.
• [50]McCormick CJ, Bonanno DR, Landorf KB. The effect of customised and sham foot orthoses on plantar pressures. J Foot Ankle Res. 2013; 6(19):1-14.
• [51]Burns J, Crosbie J, Ouvrier R, Hunt A. Effective orthotic therapy for the painful cavus foot: a randomized controlled trial. J Am Podiatr Med Assoc. 2006; 96(3):205-11.
• [52]Redmond AC, Landorf KB, Keenan AM. Contoured, prefabricated foot orthoses demonstrate comparable mechanical properties to contoured, customised foot orthoses: a plantar pressure study. J Foot Ankle Res. 2009; 2(1):1-20. BioMed Central Full Text
• [53]Kulig K, Reischl SF, Pomrantz AB, Burnfield JM, Mais-Requejo S, Thordarson DB, Smith RW. Nonsurgical management of posterior tibial tendon dysfunction with orthoses and resistive exercise: a randomized controlled trial. Phys Ther. 2009; 89(1):26-37.
• [54]Murley GS, Landorf KB, Menz HB, Bird AR. Effect of foot posture, foot orthoses and footwear on lower limb muscle activity during walking and running: a systematic review. Gait Posture. 2009; 29(2):172-87.