Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000074493
Ethics application status
Approved
Date submitted
25/11/2015
Date registered
22/01/2016
Date last updated
22/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Altered Corticospinal Excitability of Scapular Muscles in Patients with Shoulder Impingement Syndrome
Scientific title
Between patients with shoulder impingement syndrome and healthy control subjects, what is the difference of central neuromuscular control, muscle activity, scapular kinematics, and relationship among the three?
Secondary ID [1] 287984 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder impingement syndrome 296859 0
Condition category
Condition code
Musculoskeletal 297093 297093 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 297094 297094 0 0
Physiotherapy
Neurological 297198 297198 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The cortical representations of trapezius and serratus anterior muscles were examined while the subjects were seated with arm elevation of 90 degrees in the scapular plane. We used transcranial magnetic stimulation (TMS) to find the hot spot of the target muscles and the active motor threshold (AMT), motor evoked thresholds (MEPs), response latency and the cortical silent period (CSP). In addition, we stimulated the sites around the hot spot to find the mapping area and calculated the center gravity of mapping area (COG) of each target muscle. For the scapular kinematics experiment We used the Liberty electromagnetic tracing system to collect the scapular kinematics data and the scapular muscle activities were measured using the electromyography at the same time. The total duration last for about 1.5 to 2 hours.
Intervention code [1] 293324 0
Early Detection / Screening
Comparator / control treatment
The healthy control subjects were recruited in this study in order to compare the differences of central neuromuscular control, scapular kinematics, muscle activity, and the relationship among the three with patients with impingement syndrome.
Control group
Active

Outcomes
Primary outcome [1] 296701 0
The central neuromuscular control of trapezius and serratus anterior muscles were examined by transcranial magnetic stimulation (TMS)(MagStim 200 stimulator, MagStim Company,UK )
Timepoint [1] 296701 0
Immediately after the history taking.
Primary outcome [2] 296702 0
Kinematic data of the scapula measured by Liberty electromagnetic tracking system.
Timepoint [2] 296702 0
After the history taking and central neuromuscular control evaluation.
Primary outcome [3] 296703 0
Surface electromyography was used to collect the muscle activity of upper trapezius, lower trapezius, and serratus anterior.
Timepoint [3] 296703 0
After the history taking and central neuromuscular control evaluation.
Secondary outcome [1] 319141 0
Shoulder muscle strength recorded by a hand-held dynanometer.
Timepoint [1] 319141 0
Immediately after the central neuromuscular control, muscle activity and scapular kinematics evaluation.

Eligibility
Key inclusion criteria
Patients with shoulder impingement syndrome with age between 20 and 45 years old; exercise induced shoulder pain for 3 months; painful arc with active shoulder elevation; 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. Asymptomatic subjects were recruited from personal contacts. The inclusion criteria for control group included no current symptom and past history of the testing shoulder.
Minimum age
20 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) a history of shoulder dislocation, or trauma; (2) shoulder surgery in the past 6 months; (3) neurological symptoms or anesthesia on upper extremity; (3) seizure; (4) any mental implantation.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/02/2013
Date of last participant enrolment
Anticipated
Actual
10/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 7371 0
Taiwan, Province Of China
State/province [1] 7371 0
Taipei

Funding & Sponsors
Funding source category [1] 292455 0
Government body
Name [1] 292455 0
Ministry of science and technology
Country [1] 292455 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] 291153 0
None
Name [1] 291153 0
Nil
Address [1] 291153 0
Nil
Country [1] 291153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293917 0
Institutional Review Board of Taipei Veterans General Hospital
Ethics committee address [1] 293917 0
Ethics committee country [1] 293917 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 293917 0
Approval date [1] 293917 0
23/07/2012
Ethics approval number [1] 293917 0

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

Contacts
Principal investigator
Name 61786 0
A/Prof Yi-Fen Shih
Address 61786 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 61786 0
Taiwan, Province Of China
Phone 61786 0
+886 2 2826 7340
Fax 61786 0
+886 2 2820 1841
Email 61786 0
[email protected]
Contact person for public queries
Name 61787 0
Yi-Fen Shih
Address 61787 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 61787 0
Taiwan, Province Of China
Phone 61787 0
+886 2 2826 7340
Fax 61787 0
+886 2 2820 1841
Email 61787 0
[email protected]
Contact person for scientific queries
Name 61788 0
Yi-Fen Shih
Address 61788 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 61788 0
Taiwan, Province Of China
Phone 61788 0
+886 2 2826 7340
Fax 61788 0
+886 2 2820 1841
Email 61788 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
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