UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Acronym	Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Scientific Title	Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Scientific Title:Acronym	Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Region	Asia(except Japan)

Condition
Condition	pre to post-intervention
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of Therapeutic Exercise, with and without Kinesiotaping, on Clinical Outcomes in Individuals with Scapular Dyskinesis and Shoulder Impingement syndrome
Basic objectives2	Others
Basic objectives -Others	comparison the effect of corrective exercises with and without taping on pain, Electromyography, kinematics and muscle strength in female badminton players with scapular dyskinesia
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pain
Key secondary outcomes	function-DASH score kinematics Penn Shoulder Score (Total, Pain, Satisfaction, and Function)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Medicine
Interventions/Control_1	Therapeutic Exercise with taping
Interventions/Control_2	Therapeutic Exercise alone
Interventions/Control_3	control: placebo
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	45 years-old >=
Gender	Male and Female
Key inclusion criteria	Participants were eligible for this study if they had SD based on observational examination and a positive scapular assistance test or reposition test, to ensure the SIS symptoms were related to SD.
Key exclusion criteria	Participants were excluded if they had a history of surgery, fracture, or dislocation and traumatic onset of shoulder pain; existence of type 3 acromion; massive rotator cuff tear; a long head of bicep tendon tear; or degenerative joint disorder at the shoulder complex, any rheumatologic, systemic, or neurologic disorders; any neuro-musculoskeletal disorder (including cervical radiculopathy); a body mass index >30kg/m2; being pregnant, and, receiving steroid injections and physical therapy during the previous 6 months before the study.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Sarvenaz Middle name Last name Kazemipour
Organization	Kharazmi university
Division name	department of biomechanics and sport injuries
Zip code	4352763633
Address	tehran-mirdamad-sout razan street, faculty of PE
TEL	009802122258084
Email	kazempour.sarvenaz@yahoo.com

Public contact
Name of contact person	1st name amir Middle name Last name letafatkar
Organization	kharazmi University
Division name	department of biomechanics and sport injuries
Zip code	4353663663
Address	tehran-mirdamad-sout razan street, faculty of PE
TEL	00989195394692
Homepage URL
Email	letafatkaramir@yahoo.com

Sponsor
Institute	kharazmi university
Institute
Department

Funding Source
Organization	no funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	kharazmi uiversity
Address	tehran
Tel	982182883590
Email	healthcontrol@kharazmi.ac.ir

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	170
Results
Results date posted
Results Delayed
Results Delay Reason	we are submission process to journalals
Date of the first journal publication of results
Baseline Characteristics	TE+KT (n=40) TE alone (n=40) Control (n=40) P value Age, years; mean (SD) 35.4 (4.4) 40.5 (5.5) 37.5 (6.3) 0.209 Weight, kg; mean (SD) 76.1 (5.3) 73.7 (7.2) 69.4 (8.1) 0.398 Gender - female; n (%) 20 (50) 22 (55) 21 (52.5) 0.522 Arm Dominance - dominant; n (%) 11 (55) 12 (60) 12 (60) 0.528 Duration of symptoms; n (%) - - - - 6-12 weeks 14 (35) 14 (35) 13 (32.5) 0.675 Greater than 12 weeks 26 (65) 26 (65) 27 (67.5) 0.648
Participant flow
Adverse events	No significant adverse events were reported during the study. Subjects were advised to perform the exercises as long as they felt no pain or soreness. Some of the subjects (three in group 1 and four in group 2) experienced fatigue or self-limited soreness and required longer periods of rest between exercise repetitions, subsequently duration of exercise sessions was longer than stated at the outset and in some cases total dose of exercise prescription was not achieved during the first two weeks of the treatment.
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 01 Day
Date of IRB	2018 Year 08 Month 26 Day
Anticipated trial start date	2019 Year 01 Month 20 Day
Last follow-up date	2019 Year 05 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 23 Day
Last modified on	2021 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040274