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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
Type of registration
Prospectively registered

Titles & IDs
Public title
Taping and exercise for the treatment of exercise related leg pain.
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.
Secondary ID [1] 282801 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise related leg pain 289740 0
Condition category
Condition code
Musculoskeletal 290070 290070 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 290071 290071 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287624 0
Treatment: Other
Intervention code [2] 287625 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 290123 0
Severity of usual and worst pain over the preceding week using a 100mm visual analogue scale.
Timepoint [1] 290123 0
At baseline and at 1, 2, and 6 weeks after intervention commencement; then 6, 12 and 26 weeks after cessation of intervention.
Primary outcome [2] 290124 0
Global perceived improvement using a 6 point Likert scale (completely recovered, much improved, improved, no change, worse and much worse).
Timepoint [2] 290124 0
At 1, 2 and 6 weeks after intervention commencement.
Secondary outcome [1] 303974 0
Foot and Ankle Ability Measure
Timepoint [1] 303974 0
At baseline and at 1, 2, and 6 weeks after intervention commencement.
Secondary outcome [2] 303975 0
Patient Specific Functional Scale
Timepoint [2] 303975 0
At baseline and at 1, 2 and 6 weeks after intervention commencement.
Secondary outcome [3] 303976 0
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.
Timepoint [3] 303976 0
At baseline and at 1, 2, and 6 weeks after intervention commencement; then 6, 12, 18, 24 weeks after cessation of intervention.

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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2014
Actual
7/02/2014
Date of last participant enrolment
Anticipated
Actual
3/06/2019
Date of last data collection
Anticipated
Actual
27/12/2019
Sample size
Target
45
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7222 0
4014 - Banyo
Recruitment postcode(s) [2] 12231 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 12232 0
4101 - South Brisbane
Recruitment postcode(s) [4] 22299 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 287701 0
University
Name [1] 287701 0
Australian Catholic University
Country [1] 287701 0
Australia
Primary sponsor type
Individual
Name
Dr Melinda Smith
Address
School of Health and Rehabilitation Sciences
The University of Queensland
Level 8, Therapies Annexe Building #84A
St Lucia, Brisbane, Queensland 4072
Australia
Country
Australia
Secondary sponsor category [1] 286433 0
Individual
Name [1] 286433 0
Dr Mark Creaby
Address [1] 286433 0
School of Exercise Science
Australian Catholic University
PO Box 456
Virginia 4014 QLD
Country [1] 286433 0
Australia
Other collaborator category [1] 277544 0
Individual
Name [1] 277544 0
Sonia Coates
Address [1] 277544 0
School of Physiotherapy
Australian Catholic University
PO Box 968
North Sydney, 2059, NSW
Country [1] 277544 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289661 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 289661 0
Ethics committee country [1] 289661 0
Australia
Date submitted for ethics approval [1] 289661 0
Approval date [1] 289661 0
14/03/2013
Ethics approval number [1] 289661 0
2013 32Q
Ethics committee name [2] 300090 0
The University of Queensland's Human Research Ethics Committee
Ethics committee address [2] 300090 0
Ethics committee country [2] 300090 0
Australia
Date submitted for ethics approval [2] 300090 0
03/04/2018
Approval date [2] 300090 0
04/04/2018
Ethics approval number [2] 300090 0
2018000607

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41298 0
Dr Melinda Smith
Address 41298 0
School of Health and Rehabilitation Sciences
The University of Queensland
Level 8, Therapies Annexe Building #84A
St Lucia, Brisbane Queensland 4072
Australia
Country 41298 0
Australia
Phone 41298 0
+61 7 3365 1379
Fax 41298 0
Email 41298 0
melinda.smith@uq.edu.au
Contact person for public queries
Name 41299 0
Melinda Smith
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
Country 41299 0
Australia
Phone 41299 0
+61 7 3365 1379
Fax 41299 0
Email 41299 0
melinda.smith@uq.edu.au
Contact person for scientific queries
Name 41300 0
Melinda Smith
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
Country 41300 0
Australia
Phone 41300 0
+61 7 3365 1379
Fax 41300 0
Email 41300 0
melinda.smith@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Group data will be available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15090Study protocolFranettovich 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/cGWuNMelinda.smith@uq.edu.au Nil
15091Informed consent form  Melinda.smith@uq.edu.au
15092Ethical approval  Melinda.smith@uq.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA 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.2014https://dx.doi.org/10.1186/1471-2474-15-328
N.B. These documents automatically identified may not have been verified by the study sponsor.