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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
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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?
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Secondary ID [1]
297982
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
sports related shoulder injuries
312395
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sports related back injuries
312710
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Condition category
Condition code
Injuries and Accidents
310954
310954
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0
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Other injuries and accidents
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Musculoskeletal
310973
310973
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0
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Other muscular and skeletal disorders
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Physical Medicine / Rehabilitation
310974
310974
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
314216
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Prevention
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Comparator / control treatment
The control group will not receive any intervention.
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Control group
Active
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Outcomes
Primary outcome [1]
319776
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Incident of sports related shoulder injuries by a 10 min interview with a questionnaire which is designed for this study
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Assessment method [1]
319776
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Timepoint [1]
319776
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Assessed every 2 weeks for 36 weeks after initial evaluation
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Primary outcome [2]
319967
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Incident of sports related back injuries by a 10 min interview with a questionnaire which is designed for this study
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Assessment method [2]
319967
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Timepoint [2]
319967
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Assessed every 2 weeks for 36 weeks after initial evaluation
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Secondary outcome [1]
369506
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Strength by hand-held dynamometer
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Assessment method [1]
369506
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Timepoint [1]
369506
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Initiation of study and 12 weeks.
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Secondary outcome [2]
370006
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Range of motion by goniometer/ inclinometer
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Assessment method [2]
370006
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Timepoint [2]
370006
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Initiation of study and 12 weeks.
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Secondary outcome [3]
370009
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Functional movement assessment by Y-balance test set
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Assessment method [3]
370009
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Timepoint [3]
370009
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Initiation of study and 12 weeks.
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Secondary outcome [4]
370010
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Joint range of motion during movemenmt by motion capture system
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Assessment method [4]
370010
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Timepoint [4]
370010
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Initiation of study and 12 weeks.
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Secondary outcome [5]
370102
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Muscle activation by EMG sensor
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Assessment method [5]
370102
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Timepoint [5]
370102
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Initiation of study and 12 weeks.
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Secondary outcome [6]
370103
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Foot pressure by F-scan
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Assessment method [6]
370103
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Timepoint [6]
370103
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Initiation of study and 12 weeks.
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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..
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Minimum age
15
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Acute pain/ injury
2. Cervical pathology
3. Neurological / systemic disease
4. Ant musculoskeletal surgery
5. Pregnant
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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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
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/05/2020
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2022
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21413
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Taiwan, Province Of China
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State/province [1]
21413
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Taipei
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Funding & Sponsors
Funding source category [1]
302505
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Government body
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Name [1]
302505
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Ministry of Science and Technology
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Address [1]
302505
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106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C.
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Country [1]
302505
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Taiwan, Province Of China
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Primary sponsor type
Individual
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Name
Yi-fen Shih
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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.
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Country
Taiwan, Province Of China
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Secondary sponsor category [1]
302413
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None
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Name [1]
302413
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Address [1]
302413
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Country [1]
302413
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303161
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Institutional Review Board of National Yang-Ming University
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Ethics committee address [1]
303161
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No. 155, Li-Nong Street Section 2, Pei-Tou District, Institutional Review Board of National Yang-Ming University Taipei, Taiwan 112.
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Ethics committee country [1]
303161
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Taiwan, Province Of China
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Date submitted for ethics approval [1]
303161
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25/02/2019
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Approval date [1]
303161
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24/09/2019
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Ethics approval number [1]
303161
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YM108033F
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Summary
Brief summary
Background and purpose: Shoulder and back injuries are the most common injury segments in loaded overarm sports, such as weightlifting. However, the associated risk factors for injury prevention have never been explored in the previous studies. Therefore we would like to examine the effectiveness of the risk factor management and motor control training intervention on the prevention of weightlifting related shoulder and back injuries.
Methods:
We plan to recruit 60 high school/ collegiate students who have participated in weightlifting activities for more than three years, and have had repeated shoulder or back injury histories. These subject will be divided into the control group or the intervention group randomly. The demographic data will be collected, followed by measurement of musculoskeletal characteristics and motor control performance of the shoulder and back. Afterwards, the measurement of kinematics and muscle activation of the shoulder, trunk, hip, knee, and ankle, and foot pressure will be carried out during the snatch task. The control group will be monitored for 36 weeks, and the intervention group will undergo the risk factor management and motor control training for 12 weeks, followed by another 24 weeks follow-up. The effectiveness of intervention will be assessed by comparing the injury incidence and severity between the two groups.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
92694
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Prof Yi-Fen Shih
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Address
92694
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No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
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Country
92694
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Taiwan, Province Of China
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Phone
92694
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+886, 2, 28267340
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Fax
92694
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+886, 2, 28201841
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Email
92694
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[email protected]
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Contact person for public queries
Name
92695
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Prof Yi-Fen Shih
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Address
92695
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No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
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Country
92695
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Taiwan, Province Of China
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Phone
92695
0
+886, 2, 28267340
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Fax
92695
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+886, 2, 28201841
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Email
92695
0
[email protected]
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Contact person for scientific queries
Name
92696
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Prof Yi-Fen Shih
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Address
92696
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No. 155, Li-Nong Street Section 2, Pei-Tou District,
National Yang-Ming University Department of Physical Therapy and Assistive Technology Taipei, Taiwan 112.
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Country
92696
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Taiwan, Province Of China
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Phone
92696
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+886, 2, 28267340
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Fax
92696
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+886, 2, 28201841
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Email
92696
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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