Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000624381
Ethics application status
Approved
Date submitted
14/12/2016
Date registered
1/05/2017
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2024
Date results provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Kinesio Taping on the upper limb function in people with damage to the rotator cuff
Scientific title
Influence of kinesio taping method on functionality of the upper limb with damage to the rotator cuff.
Secondary ID [1] 290741 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rotator cuff injuries 301321 0
Condition category
Condition code
Musculoskeletal 301077 301077 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 301496 301496 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Material
The research material will constitute 80 persons at the age from 20 to 65 with rotator cuff injury of I and II stage. Patients will be divided into four 20-person group. To the group, I and II will be categorised persons with the injury to the I stage, of which in the I group (examined group) will be applied Kinesio Taping and 6-week rehabilitation programme, and in the II group (control group) only 6-week rehabilitation programme.
To group III and IV will be recruited patients with the II stage injury. In group III (examined group) will be applied Kinesio Taping together with a 6-week rehabilitation programme and in the IV group (control group) only 6-week rehabilitation programme.
The rehabilitation will take place on Academy of Physical Education in Cracow.
Method
At all persons involved in the project will be made twice ultrasound examination (before and after completion of the rehabilitation program, ie. after 6 weeks), functional examination according to Orthopaedic Cyriax Medicine and three-time measurement of muscle strength with Biodex System 4 dynamometer (before the first put Kinesio Tape on, after its primary application and after the end of the 6 week rehabilitation). The examination will be performed in the dynamic conditions – isometric contraction and isokinetic contarction. Moreover, every examined person will complete DASH and UEFI questionnaires, determining the feelings for the size of disability of upper limb, NHP questionnaire assessing the QoL and with VAS scale (pain assessment), each person will assess your own pain troubles. These questionnaires and VAS scale will be completed by the examined persons twice – before beginning a rehabilitation program and after its completion.
Ultrasound examination will be aimed at establishing the kind and sizes of damage within the rotator cuff. Every examination will be performed by the same doctor and with the same device for ultrasonography.
For patients from examined groups, apart from the participation in a rehabilitation programme, will be applied Kinesio Tapes of Cure Tape company on damaged muscles, and - in any case - on deltoid muscle. Then, after the tape application will be executed the measurement of muscle strength again. Tapes at each patient will be changed every 4 days within 6 weeks. The first application will be made immediately after performing the examination with Biodex System 4 dynamometer.
The tape application and supervision over rehabilitation program (running the program) will be performed by the same physical therapist (author of the project) at all examined persons.
Rehabilitation programme
The training will last for 6 weeks, patients will do exercises 3 times a week. During the day, they will be undergo one 40-minute session of rehabilitation. Patients, categorised to the group with the II stage of the damage, will undertake the exercises of internal rotation from 7th rehabilitation session. The patients categorised to the group with I stage of the demage will commence internal rotation from 1st rehabilitation session. A summary description of the session of rehabilitation: warming up exercises – duration 5 -10 minutes before the main exercises, the main exercises: stretching exercises and strengthening exercise.
A summary description of the session of rehabilitation:
Warming up exercises – duration 5 -10 minutes before the main exercises,
The main exercises:
a) stretching exercises: for muscles: deltoid muscle, infraspinatus muscle, supraspinatus muscle and subscapularis muscle
b) strengthening exercises: for ascending and central part of the trapezius muscle,
for supraspinatus muscle and teres minor, for pectoral muscles and infraspinatus muscle - internal rotation, for deltoid muscle, supraspinatus muscle and teres minor - external rotation,for biceps and triceps, for central and rear part of the deltoid muscle, supraspinatus muscle and the central part of the trapezius muscle, for serratus anterior muscle and the central part of the trapezius muscle, for internal rotation: front part of the deltoid muscle, pectoral muscles, subscapularis muscle and latissimus dorsi muscle, for external rotation: rear part of the deltoid muscle, infraspinatus muscle, teres minor.

The patients will be register of attendance at sessions.
Intervention code [1] 296647 0
Rehabilitation
Intervention code [2] 296998 0
Treatment: Other
Comparator / control treatment
control group will have only 6-week rehabilitation programme without Kinesio Taping method. Besides the examination protocol is the same as in research group.
Control group
Active

Outcomes
Primary outcome [1] 300496 0
level of dysfunction assesed by Disabilities of the Arm, Shoulder and Hand questionnaire, Upper Extermity Functional Index questionnaire
Timepoint [1] 300496 0
before 6-weeks rehabilitation program and immediately after 6-weeks rehabilitation program
Secondary outcome [1] 330122 0
assessment of quality of life after rotator cuff injury by Nottingham Health Profile
Timepoint [1] 330122 0
before 6-weeks rehabilitation program and immediately after 6-weeks rehabilitation program
Secondary outcome [2] 331115 0
strength of rotator cuff muscules measured by Biodex System 4
Timepoint [2] 331115 0
In the control group muscules strenght will be measured before 6-weeks rehabilitation program and immediately after 6-weeks rehabilitation program.
In the intervention group muscules strenght will be measured immediately prior to and following the first tape application, and at 6 weeks.
Secondary outcome [3] 331116 0
level of pain measured by VAS scale
Timepoint [3] 331116 0
before 6-weeks rehabilitation program and immediately after 6-weeks rehabilitation program
Secondary outcome [4] 332938 0
functional examination according to Orthopaedic Cyriax Medicine
Timepoint [4] 332938 0
before 6-weeks rehabilitation program and immediately after 6-weeks rehabilitation program
Secondary outcome [5] 332939 0
Severity of rotator cuff damage, assessed by ultrasound
Timepoint [5] 332939 0
before 6-weeks rehabilitation program and immediately after 6-weeks rehabilitation program

Eligibility
Key inclusion criteria
- 20 - 60 years of age
- rotator cuff injury
- lack of neuromuscular abnormalities/disturbances, skin diseases (dermatopathy).
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
– advanced degenerative alterations of the shoulder joint,
– complete breakage of tendon any one of muscles of the rotator cuff,
– damage to the tendons of other muscles of shoulder joint surrounding (with the exception of the rotator cuff)
– damage to the ligaments of the shoulder girdle,
– postoperative status of surrounding and of very shoulder joint,
– previous injuries within the shoulder joint,
– non-muscle injuries of shoulder joint surrounding,
– neuromuscular abnormalities/disturbances,
– skin diseases (dermatopathy).

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/05/2017
Actual
15/05/2017
Date of last participant enrolment
Anticipated
18/06/2017
Actual
11/03/2019
Date of last data collection
Anticipated
30/07/2017
Actual
22/04/2019
Sample size
Target
80
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8500 0
Poland
State/province [1] 8500 0
Malopolska

Funding & Sponsors
Funding source category [1] 295171 0
University
Name [1] 295171 0
University of Physical Education in Krakow
Country [1] 295171 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Krakow
Address
al. Jana Pawla II 78
31-571 Krakow
Country
Poland
Secondary sponsor category [1] 293996 0
None
Name [1] 293996 0
Address [1] 293996 0
Country [1] 293996 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296519 0
Bioethics Commission at the Regional Medical Chamber in Krakow
Ethics committee address [1] 296519 0
Ethics committee country [1] 296519 0
Poland
Date submitted for ethics approval [1] 296519 0
12/02/2015
Approval date [1] 296519 0
15/04/2015
Ethics approval number [1] 296519 0
41/KBL/OIL/2015

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

Contacts
Principal investigator
Name 70294 0
A/Prof Aneta Bac
Address 70294 0
The University of Physical Education
al. Jana Pawla II 78
31-571 Krakow
Country 70294 0
Poland
Phone 70294 0
+48126831065
Fax 70294 0
Email 70294 0
[email protected]
Contact person for public queries
Name 70295 0
Aneta Bac
Address 70295 0
The University of Physical Education
al. Jana Pawla II 78
31-571 Krakow
Country 70295 0
Poland
Phone 70295 0
+48126831065
Fax 70295 0
Email 70295 0
[email protected]
Contact person for scientific queries
Name 70296 0
Aneta Bac
Address 70296 0
The University of Physical Education
al. Jana Pawla II 78
31-571 Krakow
Country 70296 0
Poland
Phone 70296 0
+48126831065
Fax 70296 0
Email 70296 0
[email protected]

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


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
SourceTitleYear of PublicationDOI
Dimensions AIThe influence of the Kinesio Taping on selected ultrasonography measurements, and quality of life in patients with rotator cuff lesions2020https://doi.org/10.1038/s41598-020-75701-6
N.B. These documents automatically identified may not have been verified by the study sponsor.