Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000074897
Ethics application status
Approved
Date submitted
13/01/2012
Date registered
16/01/2012
Date last updated
2/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The application of sports tape to change muscle activity during a computer task.
Scientific title
Does inhibition taping reduce muscle activity during a prolonged computer typing task in healthy individuals more than sham taping and no tape condition?
Secondary ID [1] 279724 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
muscle activity during a computer task 285564 0
Condition category
Condition code
Musculoskeletal 285753 285753 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 285759 285759 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be required to complete 3 x 15 mins of standard typing under three conditions applied to the dominant trapezius muscle (muscle on top of the shoulder): no taping; sham taping; inhibitory taping. For the inhibitory taping, a rigid tape will be applied from the anterior aspect of the mid clavicle across the body of the Upper Trapezius muscles to approximately the level of the seventh rib with a posterio-inferior force to bunch the Upper Trapezius muscle fibres. For sham taping, tape will be applied without tension on the same spot of the Upper Trapezius as the inhibitory taping. Activity of this muscle during the three typing conditions will be evaluated using surface electromyography (sEMG) (non-invasive). Participants will complete a baseline 15 minute typing task immediately prior to each 15 minute intervention period (i.e. 30 minutes typing in total).
Taping will be removed after 15mins of a typing task.
Wash-out period between the 3 x 15 min testing sessions will be 3 days at least.
Intervention code [1] 284022 0
Rehabilitation
Comparator / control treatment
Arm 1: Sham taping (tape will be applied without tension on the same spot of the Upper Trapezius as the inhibitory taping)
Arm 2: Control (no taping)
Control group
Placebo

Outcomes
Primary outcome [1] 286280 0
The Amplitude Probability Distribution Function (APDF) of muscle activity of the upper and lower trapezius
This is calculated from data collected using sEMG.
Timepoint [1] 286280 0
during 15mins of a typing task before an intervention (ie, inhibition taping, sham taping or control) and during the intervention
The first 15 minute typing task will occur immediately prior to the 15 minute intervention period (i.e. 30 minutes typing in total).
Secondary outcome [1] 295501 0
The proportion of the APDF of the upper trapezius to that of the lower trapezius
This is calculated from data collected using sEMG.
Timepoint [1] 295501 0
Myoelectric data will be collected for 10sec prior to the intervention and then during the 15mins standard typing task and during each intervention (sham taping, inhibition taping and control).

Eligibility
Key inclusion criteria
Asymptomatic healthy individuals without any history of head, neck and shoulder pain or trauma for which the individuals have sought medical treatment
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with contraindication for taping (eg, skin diseases), symptoms which may affect a typing task (eg, carpal tunnel syndrome, cervical radiculopathy, and neuromuscular disorders) or score of above 2 in the Neck Disability Index (NDI).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Asymptomatic participants will be recruited via notices and flyers on university notice boards. Notices may also be placed on community notice boards in surrounding suburbs. The project will be advertised to students prior to lectures after having obtained the lecturers permission.
Participants will sign a consent form. Information on participants’ age, sex, relevant medical history, height and weight will then be collected. They will then complete two questionnaires, the NDI and a computer use questionnaire.
This study is a randomised cross-over design. Firstly, each participant will select one card from an envelope in which the order of the three interventions will be written (eg, Time 1: inhibition taping, Time 2: no tape, Time 3: sham taping). The participant gives this card to the attending researcher without viewing the contents. The envelope will contain 6 cards – corresponding to the number of possible combinations of the three conditions. The order of the intervention will be known to the therapist applying the tape only and the order of application will be blinded to each participant and the researcher undertaking the data analysis and collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 7058 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 284503 0
University
Name [1] 284503 0
The University of Queensland
Country [1] 284503 0
Australia
Primary sponsor type
Individual
Name
Hiroshi Takasaki
Address
Division of Physiotherapy, School of Health and Rehabilitation Science, The University of Queensland, Brisbane, Queensland, 4067
Country
Australia
Secondary sponsor category [1] 283433 0
Individual
Name [1] 283433 0
Venerina Johnston
Address [1] 283433 0
Division of Physiotherapy, School of Health and Rehabilitation Science, The University of Queensland, Brisbane, Queensland, 4067
Country [1] 283433 0
Australia
Other collaborator category [1] 260438 0
Individual
Name [1] 260438 0
Blane Delbridge
Address [1] 260438 0
Division of Physiotherapy, School of Health and Rehabilitation Science, The University of Queensland, Brisbane, Queensland, 4067
Country [1] 260438 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286485 0
Medical Research Ethics Committee
Ethics committee address [1] 286485 0
The University of Queensland, Brisbane, 4067
Ethics committee country [1] 286485 0
Australia
Date submitted for ethics approval [1] 286485 0
Approval date [1] 286485 0
12/01/2012
Ethics approval number [1] 286485 0
2011001309

Summary
Brief summary
Background: A primary source for the development of upper extremity musculoskeletal disorders is prolonged muscle activity. Cognitive work-load, visual load and repetitive low-load tasks during the use of a computer can increase Trapezius muscle activity, resulting in pain around the neck and shoulders. It is believed clinically, that inhibition McConnell taping applied across muscle fibers can reduce muscle activity, potentially contribute to alleviation of muscle stiffness and pain. However, there are few high quality studies which have investigated the effectiveness of this taping with varying outcomes. Hence, a comprehensive study is warranted.
Study design: Randomized Placebo Controlled Assessor Blinded Cross-over design
Subjects: Sixty asymptomatic volunteers will be recruited from university staff and students
Measures: Myoelectric activity of the upper and lower trapezius will be recorded during 3 x 15 minutes computer work using surface electromyography. The EMG data will be analysed using the Amplitude Probability Distribution Function, which is appropriate for the assessment of muscle load during a prolonged functional task.
Procedures: All subjects will perform a 15 minute standardized computer task in 3 conditions, which will be separated by at least one week as a wash-out period, following a baseline assessment with the 15 minute standardized computer task in each timepoint. Order of the 3 conditions will be randomised. In Condition 1, a rigid tape will be applied from the anterior aspect of the mid clavicle across the body of the Upper Trapezius muscles to approximately the level of the seventh rib with a posterio-inferior force to bunch the Upper Trapezius muscle fibres. In Condition 2, a tape will be applied without tension on the same spot of the Upper Trapezius (Placebo tape). Condition 3 will be the control condition without any tape applied. On completion of the taping, a towel will conceal the taping from view. The effect of taping in each allocated condition will be statistically analysed with repeated measures ANOVA or Freedman tests.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33627 0
Address 33627 0
Country 33627 0
Phone 33627 0
Fax 33627 0
Email 33627 0
Contact person for public queries
Name 16874 0
Hiroshi Takasaki
Address 16874 0
Division of Physiotherapy, School of Health and Rehabilitation Science, The University of Queensland, Brisbane, Queensland, 4067
Country 16874 0
Australia
Phone 16874 0
+61 7 3365 2275
Fax 16874 0
Email 16874 0
[email protected]
Contact person for scientific queries
Name 7802 0
Hiroshi Takasaki
Address 7802 0
Division of Physiotherapy, School of Health and Rehabilitation Science, The University of Queensland, Brisbane, Queensland, 4067
Country 7802 0
Australia
Phone 7802 0
+61 7 3365 2275
Fax 7802 0
Email 7802 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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