UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the effects of Sensorimotor training programs on pain, electromyography and kinematics in patients with Scapular Downward Rotation Syndrome
Title of the study (Brief title)	The effects of Sensorimotor training programs in patients with Scapular Downward Rotation Syndrome
Region	Asia(except Japan)

Condition
Condition	Scapular Downward Rotation Syndrome
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of the effects of six weeks sensorimotor training and sensorimotor plus passive interventions program on pain, electrical activity of selected scapular muscles and kinematics in people with scapular downward rotation syndrome (SDRS)
Basic objectives2	Others
Basic objectives -Others	To evaluate the differences between intervention programs
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain, electrical activity of selected scapular muscles and kinematics.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Intervention 1: 6-week sensorimotor training program; 3 sessions per week (1 hour each session
Interventions/Control_2	Intervention 2: 6-week sensorimotor plus Passive Interventions program; 3 sessions per week (1 hour each session)
Interventions/Control_3	Control group; total of 3 hours per week home exercise program described postural correction on daily activities.
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	20 years-old <=
Age-upper limit	27 years-old >=
Gender	Male
Key inclusion criteria	The inclusion criteria were: (1) the downwardly rotated scapula (the inferior angle moves medially, and the glenoid fossa rotates to face caudally); (2) the acromioclavicular joint lower than the sternoclavicular joint; (3) the vertebral border of the scapula less than 3 inches from the spine with tape measure (measured from the midpoint of the vertebral border of the scapula to the corresponding thoracic spinous process); (4) previous history of neck pain at least for 6 weeks; and (5) VAS score at rest between 3 and 7 (severe pain).
Key exclusion criteria	Subjects with cervical spinal fractures, neck rotation ROM of < 20 degrees, radiating pain to the upper extremity, history of unresolved cancer, neurological disorders and subjects with severe musculoskeletal disorders were excluded. Subjects were also excluded if they missed practice for three consecutive sessions or more due to neck or shoulder pain.
Target sample size	132

Research contact person
Name of lead principal investigator	Amir Letafatkar
Organization	Kharazmi University
Division name	Faculty of Physical Education and Sport Sciences
Address	Faculty of Physical Education, Kharazmi University, South Hesari St., Mirdamad Blvd., Tehran
TEL	00989357365993
Email	amir.letafatkar@khu.ac.ir

Public contact
Name of contact person	Alireza Derakhshani
Organization	Kharazmi University
Division name	Faculty of Physical Education and Sport Sciences
Address	Faculty of Physical Education, Kharazmi University, South Hesari St., Mirdamad Blvd., Tehran
TEL	00989364331192
Homepage URL
Email	std_alireza.derakhshani@khu.ac.ir

Sponsor
Institute	Kharazmi university
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2018 Year 05 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 06 Day
Last modified on	2018 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036041