Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001335583
Ethics application status
Approved
Date submitted
30/10/2015
Date registered
7/12/2015
Date last updated
22/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neuromuscular control mechanism in overarm athletes with shoulder impingement syndrome
Scientific title
In patients with shoulder impingement syndrome, what is the effect of kinesiology taping versus placebo taping on proprioception of scapulothoracic and glenohumeral joint, scapular kinematics and muscle activity, and the relationship among the three?
Secondary ID [1] 287749 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder impingement syndrome. 296619 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296860 296860 0 0
Physiotherapy
Musculoskeletal 297038 297038 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For the KT group, a licensed physiotherapist taped both the upper (I tape) and lower (Y tape) trapezius using the Kinesiology tape. The Y tape was applied to encircle the lower trapezius, and a fully stretched I-shaped tape was applied perpendicular to the muscle belly of the upper trapezius. The 3M Micropore tape without any stretch tension was applied for the placebo group.
The application for both groups only performed once, and removed immediately after the evaluation finished.
Intervention code [1] 293150 0
Rehabilitation
Intervention code [2] 293151 0
Treatment: Devices
Comparator / control treatment
The 3M Micropore tape without any stretch tension was applied for the placebo group.
The placebo tape is applied in the same manner and anatomical locations as the KT group but without any stretch tension.
Control group
Placebo

Outcomes
Primary outcome [1] 296468 0
The scapular joint position sense was measured as the reposition errors in the direction of scapular elevation, depression, protraction and retraction by Liberty electromagnetic tracking system.
Timepoint [1] 296468 0
Immediately before and after kinesiology taping applied.
Primary outcome [2] 296469 0
Kinematic data of the scapula measured by Liberty electromagnetic tracking system.
Timepoint [2] 296469 0
During arm elevation in the scapular plane immediately before and after Kinesiology taping applied.
Primary outcome [3] 296470 0
Surface electromyography was used to collect the muscle activity of upper trapezius, lower trapezius, and serratus anterior.
Timepoint [3] 296470 0
During arm elevation in the scapular plane immediately before and after Kinesiology taping applied.
Secondary outcome [1] 318521 0
Pain intensity assessed by numeric rating scale (NRS).
Timepoint [1] 318521 0
Baseline, before pretest evaluation and kinesiology taping applied.
This variable is collected for the baseline comparison between intervention group and placebo group.
Secondary outcome [2] 318522 0
Shoulder range of motion measured by an universal goniometer
Timepoint [2] 318522 0
Baseline, before pretest evaluation and kinesiology taping applied.
This variable is collected for the baseline comparison between intervention group and placebo group.
Secondary outcome [3] 318523 0
Shoulder muscle strength recorded by a hand-held dynanometer.
Timepoint [3] 318523 0
Baseline, before pretest evaluation and kinesiology taping applied.
This variable is collected for the baseline comparison between intervention group and placebo group.

Eligibility
Key inclusion criteria
Patients with shoulder impingement syndrome with age between 20 and 45 years old and showed two or more positive signs in the following impingement screening tests: (1) subacromion pain with shoulder elevation or tenderness on the greater trochanter of the humerus; (2) Neer impingement test; (3)Hawkins-Kennedy impingement test; (4) Empty can test; (5) painful arc with active shoulder elevation.
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) a history of shoulder dislocation, fracture or surgery; (2) neurological symptoms or anesthesia on upper extremity; (3) acute stage or failure to complete the examination.

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/10/2012
Date of last participant enrolment
Anticipated
Actual
1/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 7283 0
Taiwan, Province Of China
State/province [1] 7283 0
Taipei

Funding & Sponsors
Funding source category [1] 292298 0
Government body
Name [1] 292298 0
Ministry of science and technology
Country [1] 292298 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Yi-fen Shih
Address
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 290981 0
None
Name [1] 290981 0
Nil
Address [1] 290981 0
Nil
Country [1] 290981 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293774 0
Institutional Review Board of Taipei Veterans General Hospital
Ethics committee address [1] 293774 0
Ethics committee country [1] 293774 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 293774 0
01/05/2012
Approval date [1] 293774 0
22/07/2012
Ethics approval number [1] 293774 0
2012-07-009 A

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

Contacts
Principal investigator
Name 61222 0
A/Prof Yi-Fen Shih
Address 61222 0
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 61222 0
Taiwan, Province Of China
Phone 61222 0
+886 2 2826 7340
Fax 61222 0
+886 2 2820 1841
Email 61222 0
[email protected]
Contact person for public queries
Name 61223 0
Yi-Fen Shih
Address 61223 0
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 61223 0
Taiwan, Province Of China
Phone 61223 0
+886 2 2826 7340
Fax 61223 0
+886 2 2820 1841
Email 61223 0
[email protected]
Contact person for scientific queries
Name 61224 0
Yi-Fen Shih
Address 61224 0
No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
Country 61224 0
Taiwan, Province Of China
Phone 61224 0
+886 2 2826 7340
Fax 61224 0
+886 2 2820 1841
Email 61224 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

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

Documents added automatically
No additional documents have been identified.