A comparison of rigid tape and exercise, elastic tape and exercise and exercise alone on pain and lower limb function in individuals with exercise related leg pain: a randomised controlled trial

BACKGROUND: Exercise related leg pain (ERLP) is a common lower limb overuse injury characterised by pain located between the knee and ankle that occurs during activity. The high incidence of the condition, subsequent interference with participation in physical activity and substantial recovery time, highlights a need for effective interventions. Whilst many interventions have been described for the management of ERLP, currently there is a lack of high quality evidence for an effective intervention for the condition. METHODS/DESIGN: A single-blinded randomised controlled clinical trial will be conducted in a community setting. Forty-five female volunteers aged between 18 and 40 years with a history of insidious onset of pain located between the knee and ankle of at least one month duration that is aggravated by weight bearing activities will be recruited for the study. Suitable participants will be randomly allocated to one of three treatment groups for the 6 week intervention period: (i) exercise only, (ii) rigid anti-pronation tape and exercise, (iii) elastic anti-pronation tape and exercise. Outcomes will be measured at baseline, 1, 2 and 6 weeks using primary outcome measures of usual and worst pain visual analogue scale and global perceived improvement. Secondary outcome measures will include Foot and Ankle Ability Measure, Patient Specific Functional Scale and amount of activity in the previous week. In addition, participants will be contacted by phone to obtain primary and secondary outcome measures at 12, 18, 24 and 30 weeks. DISCUSSION: This article describes a single-blinded randomised controlled clinical trial that will utilise high quality methodologies in accordance with CONSORT guidelines. The results of this study will contribute to the limited knowledge regarding effective interventions for the management of ERLP. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12613000914763) ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/1471-2474-15-328) contains supplementary material, which is available to authorized users.