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Trial registered on ANZCTR


Registration number
ACTRN12619000752167
Ethics application status
Approved
Date submitted
25/04/2019
Date registered
21/05/2019
Date last updated
3/10/2019
Date data sharing statement initially provided
21/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sports related shoulder-back injuries and movement control in loaded overarm sports - The effect of specified exercise intervention for preventing recurrent sports related shoulder-back injuries
Scientific title
In patients with sports related shoulder-back injuries and movement control in loaded overarm sports, Could specified exercise intervention for managing risk predictors prevent recurrent sports injuries?
Secondary ID [1] 297982 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sports related shoulder injuries 312395 0
sports related back injuries 312710 0
Condition category
Condition code
Injuries and Accidents 310954 310954 0 0
Other injuries and accidents
Musculoskeletal 310973 310973 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 310974 310974 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The following evaluation will be performed for identifying the situation of risk predictors.

1. Strength: The strength of major muscles in loaded overarm sports, including bilateral biceps brachii, deltoid, trapezius, pectoris major, shoulder external rotator, latissimus dorsi, gluteus maximum, hamstring, quadriceps, hip abductor and hip rotator, will be measured by hand-held dynamometer.
2. Range of motion: All direction of movement in injury-related joints, bilateral shoulder, hip, knee, ankle, and thoracic, lumbar spine, will be measured by goniometer/ inclinometer.
3. Functional movement assessment: Y-balance test for upper limb and functional movement screening (FMS)
4. Kinematics, muscle activation and foot pressure: The kinematic data, muscle activation and foot pressure will be recorded when performing loaded overarm sports. For the kinematic variables, there include joint movement of bilateral shoulder, hip, knee, ankle and thoracic, lumbar spine. The electromyography will measurement in the injured side, which include biceps brachii, deltoid, upper and lower trapizeus, erector spinus, gluteus maximum, quadriceps and semitendinosus. A pair of foot pressure insole will put inside the shoes during test.

For improving the movement control, each individual in experimental group will receive a specified one-on-one exercise program. These exercise program are designed based on the results of functional movement assessment, target Borg RPE set as 3, and perform by physiotherapies with 30 minutes per section, twice a week for 12 weeks. For example, the shoulder movement control training, performing dissociation shoulder movement slowly and smoothly, will be assigned for subject who has uncontrolled movement, e.g. cannot just perform the movement in one joint which has some accompany movement in other joint, and pain in shoulder joint.
Subjects will be asked to participate at least 20 sections, and sign in an intervention calendar for counting the attending rate.
Incident of sports related shoulder-back injuries will be recognized from the interview by physiotherapies per 2 weeks and following up for 24 weeks.
Intervention code [1] 314216 0
Prevention
Comparator / control treatment
The control group will not receive any intervention.
Control group
Active

Outcomes
Primary outcome [1] 319776 0
Incident of sports related shoulder injuries by a 10 min interview with a questionnaire which is designed for this study
Timepoint [1] 319776 0
Assessed every 2 weeks for 36 weeks after initial evaluation
Primary outcome [2] 319967 0
Incident of sports related back injuries by a 10 min interview with a questionnaire which is designed for this study
Timepoint [2] 319967 0
Assessed every 2 weeks for 36 weeks after initial evaluation
Secondary outcome [1] 369506 0
Strength by hand-held dynamometer
Timepoint [1] 369506 0
Initiation of study and 12 weeks.
Secondary outcome [2] 370006 0
Range of motion by goniometer/ inclinometer
Timepoint [2] 370006 0
Initiation of study and 12 weeks.
Secondary outcome [3] 370009 0
Functional movement assessment by Y-balance test set
Timepoint [3] 370009 0
Initiation of study and 12 weeks.
Secondary outcome [4] 370010 0
Joint range of motion during movemenmt by motion capture system
Timepoint [4] 370010 0
Initiation of study and 12 weeks.
Secondary outcome [5] 370102 0
Muscle activation by EMG sensor
Timepoint [5] 370102 0
Initiation of study and 12 weeks.
Secondary outcome [6] 370103 0
Foot pressure by F-scan
Timepoint [6] 370103 0
Initiation of study and 12 weeks.

Eligibility
Key inclusion criteria
1. Performing the loaded overarm sports more than 3 years and under regular training with instruction more than a year.
2. Occurring shoulder-back pain which is related to the loaded overarm sports more than 3 months and paused the training more 3 days in a past year..
Minimum age
15 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute pain/ injury
2. Cervical pathology
3. Neurological / systemic disease
4. Ant musculoskeletal surgery
5. Pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All subject will be randomized into either the control or the intervention group by drawing lots
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 21413 0
Taiwan, Province Of China
State/province [1] 21413 0
Taipei

Funding & Sponsors
Funding source category [1] 302505 0
Government body
Name [1] 302505 0
Ministry of Science and Technology
Country [1] 302505 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] 302413 0
None
Name [1] 302413 0
Address [1] 302413 0
Country [1] 302413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303161 0
Institutional Review Board of National Yang-Ming University
Ethics committee address [1] 303161 0
Ethics committee country [1] 303161 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 303161 0
25/02/2019
Approval date [1] 303161 0
24/09/2019
Ethics approval number [1] 303161 0
YM108033F

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

Contacts
Principal investigator
Name 92694 0
Prof Yi-Fen Shih
Address 92694 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 92694 0
Taiwan, Province Of China
Phone 92694 0
+886, 2, 28267340
Fax 92694 0
+886, 2, 28201841
Email 92694 0
yfshih@ym.edu.tw
Contact person for public queries
Name 92695 0
Yi-Fen Shih
Address 92695 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 92695 0
Taiwan, Province Of China
Phone 92695 0
+886, 2, 28267340
Fax 92695 0
+886, 2, 28201841
Email 92695 0
yfshih@ym.edu.tw
Contact person for scientific queries
Name 92696 0
Yi-Fen Shih
Address 92696 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 92696 0
Taiwan, Province Of China
Phone 92696 0
+886, 2, 28267340
Fax 92696 0
+886, 2, 28201841
Email 92696 0
yfshih@ym.edu.tw

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No additional documents have been identified.