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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.

Franettovich Smith MM, Coates SS, Creaby MW - BMC Musculoskelet Disord (2014)

Bottom Line: 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.In addition, participants will be contacted by phone to obtain primary and secondary outcome measures at 12, 18, 24 and 30 weeks.

View Article: PubMed Central - PubMed

Affiliation: School of Physiotherapy, Australian Catholic University, Brisbane, Australia. melinda.smith@acu.edu.au.

ABSTRACT

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).

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Related in: MedlinePlus

Flow chart of participants through study.
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Fig1: Flow chart of participants through study.

Mentions: A randomised controlled clinical trial will be conducted in a community setting over a 12 month period. The Australian Catholic University Human Research Ethics Committee has granted ethical approval and all participants will provide informed written consent prior to commencement in the trial. An individual independent to the trial will perform the computer-generated randomisation sequence and preparation of envelopes containing the group allocation. The physiotherapist will communicate with participants regarding group allocation; due to the nature of the intervention it will not be possible to blind the treating physiotherapist or the participants. An assessor blinded to group allocation will perform outcome measurements at all time points. Data entry and statistical analysis will be performed by a blinded assessor. Figure 1 provides an overview of the study protocol.Figure 1


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.

Franettovich Smith MM, Coates SS, Creaby MW - BMC Musculoskelet Disord (2014)

Flow chart of participants through study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4201713&req=5

Fig1: Flow chart of participants through study.
Mentions: A randomised controlled clinical trial will be conducted in a community setting over a 12 month period. The Australian Catholic University Human Research Ethics Committee has granted ethical approval and all participants will provide informed written consent prior to commencement in the trial. An individual independent to the trial will perform the computer-generated randomisation sequence and preparation of envelopes containing the group allocation. The physiotherapist will communicate with participants regarding group allocation; due to the nature of the intervention it will not be possible to blind the treating physiotherapist or the participants. An assessor blinded to group allocation will perform outcome measurements at all time points. Data entry and statistical analysis will be performed by a blinded assessor. Figure 1 provides an overview of the study protocol.Figure 1

Bottom Line: 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.In addition, participants will be contacted by phone to obtain primary and secondary outcome measures at 12, 18, 24 and 30 weeks.

View Article: PubMed Central - PubMed

Affiliation: School of Physiotherapy, Australian Catholic University, Brisbane, Australia. melinda.smith@acu.edu.au.

ABSTRACT

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).

Show MeSH
Related in: MedlinePlus