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Trial registered on ANZCTR
Registration number
ACTRN12613000914763
Ethics application status
Approved
Date submitted
2/08/2013
Date registered
16/08/2013
Date last updated
15/02/2022
Date data sharing statement initially provided
13/03/2019
Date results information initially provided
15/02/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Taping and exercise for the treatment of exercise related leg pain.
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Scientific title
A comparison of the short term effects 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.
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Secondary ID [1]
282801
0
NIL
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Exercise related leg pain
289740
0
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Condition category
Condition code
Musculoskeletal
290070
290070
0
0
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Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation
290071
290071
0
0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arm 1: Participants in this group will receive advice and education related to load management and will be prescribed an exercise program to perform at home. Advice and education will be provided for the first week of the study. This will involve one individual face-to-face session of approximately 10-15 minutes with the treating physiotherapist for the study at the beginning of week 1 of the study. Individuals will be provided with a printed handout explaining exercise related leg pain and advised to monitor activity (load) and symptoms via the use of an activity diary. At the beginning of week 2, the participant will attend a half hour physiotherapy session where advice and education will be reinforced and training in the exercise program will occur. The exercise program will include two exercises: (i) foot form strengthening exercise, and (ii) gluteus medius and maximus strengthening exercise. Participants will be instructed to perform the exercises daily (the program will take no more than 10 to 15 minutes) and record in a training diary for the duration of week 2 of the study. At the beginning of week 3, the participant will attend a half hour physiotherapy session to reinforce advice and education, review the exercise program and progress exercises as able. Participants will be instructed to perform the exercises daily and record in a training diary for a further 4 weeks. Participants will be contacted weekly to check progress and encourage compliance.
Arm 2: Participants will receive advice and education related to load management, be prescribed a progressive exercise program and wear an augmented low-Dye (ALD) taping technique. At the beginning of week one, advice and education will be provided and ALD tape will be applied. Advice and education will involve one individual face-to-face session of approximately 10-15 minutes with the treating physiotherapist for the study. Individuals will be provided with a printed handout explaining exercise related leg pain and advised to monitor activity (load) and symptoms via the use of an activity diary. Throughout the study ALD taping will be applied to all participants by the same experienced physiotherapist using a rigid sports tape (38 mm zinc oxide adhesive, Leukosport BDF). ALD tape will remain in situ for the duration of the first week of the study. Participants will be re-taped half way through week 1. At the beginning of week 2, the participant will attend a half hour physiotherapy session where advice and education will be reinforced and training in the exercise program will occur. The exercise program will include the same two exercises as Arm 1 of the study: (i) foot form strengthening exercise, and (ii) gluteus medius and maximus strengthening exercise. Participants will be instructed to perform the exercises daily (the program will take no more than 10 to 15 minutes) and record in a training diary for the duration of week 2 of the study. At this session, the ALD tape will be re-applied. ALD tape will remain in situ for the duration of the second week of the study. Participants will be re-taped half way through week 2. At the beginning of week 3, the participant will attend a half hour physiotherapy session to reinforce advice and education, review the exercise program and progress exercises as able. Participants will be instructed to perform the exercises daily and record in a training diary for a further 4 weeks. Participants will be contacted weekly to check progress and encourage compliance. No tape will be applied during these final 4 weeks of the intervention.
Arm 3: Participants will receive advice and education related to load management, be prescribed a progressive exercise program and wear an anti-pronation elastic tape technique. At the beginning of week one, advice and education will be provided and the elastic tape technique will be applied. Advice and education will involve one individual face-to-face session of approximately 10-15 minutes with the treating physiotherapist for the study. Individuals will be provided with a printed handout explaining exercise related leg pain and advised to monitor activity (load) and symptoms via the use of an activity diary. Throughout the study the anti-pronation elastic taping technique will be applied to all participants by the same experienced physiotherapist (50mm, Beige Dynamic Tape). Elastic tape will remain in situ for the duration of the first week of the study. Participants will be re-taped half way through week 1. At the beginning of week 2, the participant will attend a half hour physiotherapy session where advice and education will be reinforced and training in the exercise program will occur. The exercise program will include the same two exercises as Arm 1 of the study: (i) foot form strengthening exercise, and (ii) gluteus medius and maximus strengthening exercise. Participants will be instructed to perform the exercises daily (the program will take no more than 10 to 15 minutes) and record in a training diary for the duration of week 2 of the study. At this session, the elastic tape will be re-applied. Elastic tape will remain in situ for the duration of the second week of the study. Participants will be re-taped half way through week 2. At the beginning of week 3, the participant will attend a half hour physiotherapy session to reinforce advice and education, review the exercise program and progress exercises as able. Participants will be instructed to perform the exercises daily and record in a training diary for a further 4 weeks. Participants will be contacted weekly to check progress and encourage compliance. No tape will be applied during these final 4 weeks of the intervention.
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Intervention code [1]
287624
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Treatment: Other
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Intervention code [2]
287625
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Rehabilitation
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Comparator / control treatment
Active control group: Arm 1
Participants in this group will receive advice and education related to load management and will be prescribed an exercise program to perform at home. Advice and education will be provided for the first week of the study. This will involve one individual face-to-face session of approximately 10-15 minutes with the treating physiotherapist for the study at the beginning of week 1 of the study. Individuals will be provided with a printed handout explaining exercise related leg pain and advised to monitor activity (load) and symptoms via the use of an activity diary. At the beginning of week 2, the participant will attend a half hour physiotherapy session where advice and education will be reinforced and training in the exercise program will occur. The exercise program will include two exercises: (i) foot form strengthening exercise, and (ii) gluteus medius and maximus strengthening exercise. Participants will be instructed to perform the exercises daily (the program will take no more than 10 to 15 minutes) and record in a training diary for the duration of week 2 of the study. At the beginning of week 3, the participant will attend a half hour physiotherapy session to reinforce advice and education, review the exercise program and progress exercises as able. Participants will be instructed to perform the exercises daily and record in a training diary for a further 4 weeks. Participants will be contacted weekly to check progress and encourage compliance.
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Control group
Active
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Outcomes
Primary outcome [1]
290123
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Severity of usual and worst pain over the preceding week using a 100mm visual analogue scale.
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Assessment method [1]
290123
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Timepoint [1]
290123
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At baseline and at 1, 2, and 6 weeks after intervention commencement; then 6, 12 and 26 weeks after cessation of intervention.
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Primary outcome [2]
290124
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Global perceived improvement using a 6 point Likert scale (completely recovered, much improved, improved, no change, worse and much worse).
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Assessment method [2]
290124
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Timepoint [2]
290124
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At 1, 2 and 6 weeks after intervention commencement.
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Secondary outcome [1]
303974
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Foot and Ankle Ability Measure
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Assessment method [1]
303974
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Timepoint [1]
303974
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At baseline and at 1, 2, and 6 weeks after intervention commencement.
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Secondary outcome [2]
303975
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Patient Specific Functional Scale
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Assessment method [2]
303975
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Timepoint [2]
303975
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At baseline and at 1, 2 and 6 weeks after intervention commencement.
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Secondary outcome [3]
303976
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Amount of activity performed in the previous week.
This will be expressed as kcal/day and determined using the method described by Sallis et al 1985. In this method independent self-reports of vigorous activity (at least 6 metabolic equivalents (METs) ) or moderate activity (3-5 METs) are used to calculate total energy expenditure (kilocalories per day).
Sallis JF, Haskell WL, Wood PD, et al. Physical activity assessment methodology in the Five-City Project. Am J Epidemiol. 1985; 121:91-106.
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Assessment method [3]
303976
0
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Timepoint [3]
303976
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At baseline and at 1, 2, and 6 weeks after intervention commencement; then 6, 12, 18, 24 weeks after cessation of intervention.
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Eligibility
Key inclusion criteria
Female volunteers will be eligible for participation in the trial on the basis of the following criteria: age 18 to 40 years, insidious onset of pain unrelated to any traumatic event, pain located between the knee and ankle of at least one month duration that is aggravated by weight bearing activities such as running, hopping or jumping, and worst pain over the previous week of at least 30mm on a 100mm visual analogue scale.
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Volunteers will be excluded if they have any of the following: a history of surgery to the lower limb, a cardiac condition, a known allergy to adhesive strapping tape, a known bleeding disorder or taking blood anti-coagulant medication, aichmophobia (fear of needles), known transmissible blood infection (e.g. HIV, hepatitis), or symptoms of radiculopathy or other neurologic involvement. Extensive previous exposure to either taping technique will also exclude volunteers from participation in order to prevent bias to one intervention.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
45 female volunteers will be recruited from paid advertisements in local community newspapers, and supported by regular postings of advertisements on noticeboards within the University and wider community (e.g. gymnasiums, sporting clubs, health clinics). Each potential participant who responds to advertisements will undergo a screening process (via phone or email) to determine eligibility. Eligible volunteers will be provided with an information sheet thoroughly explaining the study and informed written consent to participate in the study will be obtained. Once eligibility has been determined and the informed consent process completed, participants will be assigned an identification number.
Enrolled participants will attend a baseline testing session in which Primary and Secondary Outcome measures will be performed. At conclusion of all baseline measures, the participant will be notified of group allocation. For group allocation, a computer-generated table of random numbers (in three blocks) will be used for the randomisation sequence. An individual not otherwise involved in the study will place the randomisation sequence in a series of consecutively numbered opaque envelopes, and sign across the seal of the envelope. Allocation will be concealed from the outcome assessor at all times and from the physiotherapist delivering advice/education and exercise prescription until the point of treatment.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer-generated table of random numbers (in three blocks).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size calculations indicate that 45 participants will be sufficient to detect (i) a clinically significant improvement of 20mm in pain severity based on a standard deviation of 12.7mm, power of 0.80 and alpha level 0.05 and (ii) a clinically significant improvement of 9 points on the Foot and Ankle Ability Measure based on a standard deviation of 26.7, power of 0.80 and alpha level of 0.05.
Data processing and data entry will be performed by a research assessor who is blinded to group allocation. Statistical analyses will be performed on a blinded, intention to treat basis using SPSS software. Demographic data and clinical characteristics of pain at baseline will be examined for comparability across the three intervention groups.
The primary outcome measure of global perceived improvement will be dichotomised to either success (completely recovered, much improved, improved) or no success (no change, worse, much worse) and expressed as relative risk reduction and numbers needed to treat.
To evaluate the effect of the interventions on pain and function (Visual Analogue Scale, Foot and Ankle Ability Measure), a two-way repeated measure analysis of covariance, with between subject factor of group and within subject factor of test session, will be performed.
Age, weight and height will be included as covariates and the alpha level will be set at 0.05. Significant effects on the repeated measure analysis of covariance will be followed up with tests of simple contrasts for pairwise comparisons with a Bonferroni corrected alpha level to account for multiple comparisons.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
31/01/2014
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Actual
7/02/2014
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Date of last participant enrolment
Anticipated
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Actual
3/06/2019
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Date of last data collection
Anticipated
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Actual
27/12/2019
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Sample size
Target
45
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Accrual to date
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Final
42
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
7222
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4014 - Banyo
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Recruitment postcode(s) [2]
12231
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
12232
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4101 - South Brisbane
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Recruitment postcode(s) [4]
22299
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4072 - University Of Queensland
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Funding & Sponsors
Funding source category [1]
287701
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University
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Name [1]
287701
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Australian Catholic University
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Address [1]
287701
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1100 Nudgee Road
Banyo 4014 QLD
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Country [1]
287701
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Australia
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Primary sponsor type
Individual
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Name
Dr Melinda Smith
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Address
School of Health and Rehabilitation Sciences
The University of Queensland
Level 8, Therapies Annexe Building #84A
St Lucia, Brisbane, Queensland 4072
Australia
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Country
Australia
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Secondary sponsor category [1]
286433
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Individual
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Name [1]
286433
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Dr Mark Creaby
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Address [1]
286433
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School of Exercise Science
Australian Catholic University
PO Box 456
Virginia 4014 QLD
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Country [1]
286433
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Australia
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Other collaborator category [1]
277544
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Individual
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Name [1]
277544
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Sonia Coates
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Address [1]
277544
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School of Physiotherapy
Australian Catholic University
PO Box 968
North Sydney, 2059, NSW
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Country [1]
277544
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289661
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Australian Catholic University Human Research Ethics Committee
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Ethics committee address [1]
289661
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Chair, HREC
c/o Office of the Deputy Vice Chancellor (Research)
Australian Catholic University
Melbourne Campus
Locked Bag 4115
FITZROY, VIC, 3065
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Ethics committee country [1]
289661
0
Australia
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Date submitted for ethics approval [1]
289661
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Approval date [1]
289661
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14/03/2013
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Ethics approval number [1]
289661
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2013 32Q
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Ethics committee name [2]
300090
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The University of Queensland's Human Research Ethics Committee
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Ethics committee address [2]
300090
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Cumbrae-Stewart Building #72
The University of Queensland
St Lucia
4072
QLD
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Ethics committee country [2]
300090
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Australia
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Date submitted for ethics approval [2]
300090
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03/04/2018
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Approval date [2]
300090
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04/04/2018
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Ethics approval number [2]
300090
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2018000607
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Summary
Brief summary
Exercise related leg pain (ERLP) is a common lower limb overuse injury that often leads to interruption of physical activity. Appropriate management of ERLP is vital in assisting individuals to return to full activity, particularly given that previous history of injury is a strong risk factor in development of the condition. Taping techniques of the leg/ankle/foot are frequently used by clinicians in the management of ERLP. Despite this, no scientific study has evaluated the effectiveness of taping to reduce symptoms and improve function in ERLP. Whilst there is one previous study that has investigated the effect of rigid taping techniques on lower limb movement patterns, muscle activity and foot posture, there is no study that has investigated the effects of elastic taping. This is concerning given the rapid clinical uptake of these elastic taping techniques. An improved understanding of these taping techniques will facilitate the clinician in selecting the most suitable technique and increase the likelihood of success. This project aims to evaluate the effectiveness of rigid and elastic taping techniques in addition to exercise alone for the treatment of exercise related leg pain. We hypothesise that the addition of rigid or elastic taping to exercise will produce superior improvements in pain and function compared to exercise alone.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
41298
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Dr Melinda Smith
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Address
41298
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School of Health and Rehabilitation Sciences
The University of Queensland
Level 8, Therapies Annexe Building #84A
St Lucia, Brisbane Queensland 4072
Australia
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Country
41298
0
Australia
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Phone
41298
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+61 7 3365 1379
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Fax
41298
0
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Email
41298
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[email protected]
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Contact person for public queries
Name
41299
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Dr Melinda Smith
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Address
41299
0
School of Health and Rehabilitation Sciences
The University of Queensland
Level 8, Therapies Annexe Building #84A
St Lucia, Brisbane Queensland 4072
Australia
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Country
41299
0
Australia
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Phone
41299
0
+61 7 3365 1379
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Fax
41299
0
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Email
41299
0
[email protected]
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Contact person for scientific queries
Name
41300
0
Dr Melinda Smith
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Address
41300
0
School of Health and Rehabilitation Sciences
The University of Queensland
Level 8, Therapies Annexe Building #84A
St Lucia, Brisbane Queensland 4072
Australia
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Country
41300
0
Australia
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Phone
41300
0
+61 7 3365 1379
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Fax
41300
0
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Email
41300
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Group data will be available
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
15090
Study protocol
Franettovich Smith, Coates, S. S., & Creaby, M. W. (2014). 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. BMC Musculoskeletal Disorders, 15(1), 328–328. https://doi.org/10.1186/1471-2474-15-328
https://rdcu.be/cGWuN
[email protected]
Nil
15091
Informed consent form
[email protected]
15092
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
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.
2014
https://dx.doi.org/10.1186/1471-2474-15-328
N.B. These documents automatically identified may not have been verified by the study sponsor.
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