Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000821291
Ethics application status
Approved
Date submitted
9/05/2018
Date registered
14/05/2018
Date last updated
7/08/2019
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Effects between Dynamic Taping and Rigid Taping in Symptomatic Volleyball Players with Shoulder Anterior Instability
Scientific title
Comparison of Effects between Dynamic Taping and Rigid Taping in Symptomatic Volleyball Players with Shoulder Anterior Instability
Secondary ID [1] 294769 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Anterior Instability
307668 0
Condition category
Condition code
Musculoskeletal 306734 306734 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 306735 306735 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The dynamic taping group (5cm, Dynamic Tape Eco® ): a single session of dynamic taping by a physiotherapist. First, patients will be asked to relax their forearm on a table with slight shoulder flexion and abduction, keep the scapula in an upward rotated and posteriorly tilted position. The middle 10cm of the first tape will be used as the anchor and it will be placed on the distal 1/3 humerus. The posterior part of the tape will be spiral to the medial side and go straight up along the humerus, cover the anterior side of the glenohumeral joint, then go to the back, follow the direction of lower trapezius muscle fiber and finish at the area of T10-T12. Patients will be asked to keep the scapula in the same position then flex the shoulder to 90 degrees. The anterior part of the tape will be spiral up along the humerus and cover the anterior side of the glenohumeral joint, then finish in the pectoral area.
Before the physiotherapist applies the second and the third tapes, patients will be asked to go back to the starting position, the second tape will start on anterior deltoid, then go up posteriorly and cover the AC joint, finish in the cervicothoracic junction. The third tape will start on posterior deltoid, then go up anteriorly and cover the AC joint, finish on the medial third of the clavicle.
The taping will be taken off after the post-test.
Two taping conditions will occur on the same day and there will be a 15-minutes interval between two conditions.
Intervention code [1] 301070 0
Rehabilitation
Comparator / control treatment
The rigid tape group (3.8cm, Leukotape®, and 5cm, hypafix tape):
a single session of rigid taping by a physiotherapist. Patients will be asked to relax their forearms on a table with slight shoulder flexion and abduction, keep the scapula in an upward rotated and posteriorly tilted position. The first tape will start on anterior deltoid, then go up posteriorly and cover the AC joint, finish on the cervicothoracic junction. The second tape will start on posterior deltoid, then go up anteriorly and cover the AC joint, finish on the medial third of the clavicle. The third tape will start on the coracoid process, cover the anterior side of the glenohumeral joint and go back to the midline, finish at the area of T10-T12.
The taping will be taken off after the post-test.
Two taping conditions will occur on the same day and there will be a 15-minutes interval between two conditions.
Control group
Active

Outcomes
Primary outcome [1] 305731 0
Primary outcome 1: Pain intensity assessed by a numeric rating scale (NRS).
Timepoint [1] 305731 0
Baseline, immediately after dynamic taping and immediately after rigid taping. Timepoint of during sports activity will be added.
Primary outcome [2] 305732 0
Primary outcome 2: Anterior displacement of the humeral head assessed by a laser displacement sensor (OD max 350-100T1, SICK Taiwan Co., Ltd, Taipei, Taiwan) and a Hand-held dynamometer (MicroFET 2TM, MicroFET, Draper, UT, USA). This is a composite outcome
Timepoint [2] 305732 0
Baseline, immediately after dynamic taping and immediately after rigid taping
Primary outcome [3] 305733 0
Primary outcome 3: Tape comfort and restriction assessed by a self-designed questionnaire, including subjective comfort and restriction in resting, during movement and during exercising after taping, this is a composite outcome
Timepoint [3] 305733 0
Immediately after dynamic taping and immediately after rigid taping
Secondary outcome [1] 346302 0
Secondary outcome 1: dynamic anterior displacement of the humeral head will be assessed by the Kinetic Medial Rotation Test (KMRT) of the shoulder. A laser sensor instrument will be used to quantify the change of distance after taping.
Timepoint [1] 346302 0
Baseline, immediately after dynamic taping and immediately after rigid taping
Secondary outcome [2] 346303 0
Secondary Outcome 2:Perceived improvement will be assessed by the global rating of change scale (GROC)
Timepoint [2] 346303 0
Immediately after dynamic taping and immediately after rigid taping
Secondary outcome [3] 346304 0
Secondary Outcome 3: Shoulder abduction range of motion will be assessed by a universal goniometer.
Timepoint [3] 346304 0
Baseline, immediately after dynamic taping and immediately after rigid taping
Secondary outcome [4] 346727 0
Secondary Outcome 4: Shoulder flexion range of motion will be assessed by a universal goniometer.
Timepoint [4] 346727 0
Baseline, immediately after dynamic taping and immediately after rigid taping
Secondary outcome [5] 346728 0
Secondary Outcome 5: Shoulder external rotation range of motion will be assessed by a universal goniometer.
Timepoint [5] 346728 0
Baseline, immediately after dynamic taping and immediately after rigid taping
Secondary outcome [6] 346729 0
Secondary Outcome 6: Shoulder internal rotation range of motion will be assessed by a universal goniometer.
Timepoint [6] 346729 0
Baseline, immediately after dynamic taping and immediately after rigid taping

Eligibility
Key inclusion criteria
1. Patients with shoulder pain during overhead activity aged from 18-30 years
2. Insidious onset
3. Positive shoulder anterior instability tests
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute shoulder pain
2. Symptom reproduced by neck movement or tenderness over AC joint.
3. Previous allergic response to tape.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Gender will be used for stratification
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures analyses of variance (ANOVA) with 2 within-subjects factors and appropriate post-hoc pairwise comparisons will be used to determine if there will be significant differences in outcome variables. The significant level will be set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2018
Actual
12/12/2018
Date of last participant enrolment
Anticipated
31/08/2019
Actual
27/04/2019
Date of last data collection
Anticipated
31/08/2019
Actual
29/04/2019
Sample size
Target
40
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 10371 0
Taiwan, Province Of China
State/province [1] 10371 0
Taipei city

Funding & Sponsors
Funding source category [1] 299374 0
University
Name [1] 299374 0
National Yang-Ming University
Country [1] 299374 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
No.155, Sec.2, Linong Street, Beitou District, Taipei, 112 Taiwan (ROC)
Country
Taiwan, Province Of China
Secondary sponsor category [1] 298653 0
None
Name [1] 298653 0
Address [1] 298653 0
Country [1] 298653 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300277 0
National Yang-Ming University Institutional Review Board (IRB)
Ethics committee address [1] 300277 0
Ethics committee country [1] 300277 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 300277 0
15/03/2018
Approval date [1] 300277 0
19/04/2018
Ethics approval number [1] 300277 0
YM107029F

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

Contacts
Principal investigator
Name 83130 0
A/Prof Tzyy-Jiuan Wang
Address 83130 0
No.155, Sec.2, Linong Street, Beitou District, Taipei
Country 83130 0
Taiwan, Province Of China
Phone 83130 0
+886-2-2826-7091
Fax 83130 0
+886-2-2820-1841
Email 83130 0
[email protected]
Contact person for public queries
Name 83131 0
Tzyy-Jiuan Wang
Address 83131 0
No.155, Sec.2, Linong Street, Beitou District, Taipei
Country 83131 0
Taiwan, Province Of China
Phone 83131 0
+886-2-2826-7091
Fax 83131 0
+886-2-2820-1841
Email 83131 0
[email protected]
Contact person for scientific queries
Name 83132 0
Tzyy-Jiuan Wang
Address 83132 0
No.155, Sec.2, Linong Street, Beitou District, Taipei
Country 83132 0
Taiwan, Province Of China
Phone 83132 0
+886-2-2826-7091
Fax 83132 0
+886-2-2820-1841
Email 83132 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.