UMIN-CTR Clinical Trial

Public title

Comparing the effects of SUREE programs on people with Scapular Downward Rotation Syndrome: Randomized Clinical Trial

Acronym

Effects of SUREE in Subjects with SDRS

Scientific Title

Comparing the effects of SUREE programs on people with Scapular Downward Rotation Syndrome: Randomized Clinical Trial

Scientific Title:Acronym

Effects of SUREE in Subjects with SDRS

Region

Asia(except Japan)

Condition

Scapular Downward Rotation Syndrome

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of 6-week Scapular Upward Rotation and Elevation Exercises (SUREE) with and without Visual Feedback on pain, ROM and proprioception in people with Scapular Downward Rotation Syndrome (SDRS)

Basic objectives2

Others

Basic objectives -Others

To evaluate the differences between 6-week SUREE with and without Visual Feedback programs

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Pain intensity, Neck flexion and rotation ROM and proprioception in subjects with Scapular Downward Rotation Syndrome before and after interventions

Key secondary outcomes

Differences between 6-week SUREE with and without Visual Feedback programs

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Intervention 1: 6-week SUREE program; 3 sessions per week (1 hour each session)

Interventions/Control_2

Intervention 2: 6-week SUREE plus visual feedback program; 3 sessions per week (1 hour each session)

Interventions/Control_3

Intervention 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

Age-lower limit

20

years-old

<=

Age-upper limit

27

years-old

>=

Gender

Male and Female

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

42

Name of lead principal investigator

1st name
Middle name
Last name	Amir Letafatkar

Organization

Kharazmi University

Division name

Faculty of Physical Education and Sport Sciences

Zip code

Address

Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj

TEL

00989357365993

Email

letafatkaramir@yahoo.com

Name of contact person

1st name
Middle name
Last name	Alireza Derakhshani

Organization

Kharazmi University

Division name

Faculty of Physical Education and Sport Sciences

Zip code

Address

Faculty of Physical Education, Kharazmi University, Kharazmi Blvd., Shahid Beheshti St., Karaj

TEL

00989364331192

Homepage URL

Email

alireza.derakhshani71@gmail.com

Institute

Kharazmi University

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

The results showed statistically significant changes within the experimental groups in all variables except for the neck rotation ROM in the SUREE without Visual Feedback. However, there were no changes in the control group before and after the interventions in all dependent variables. Also, there were no significant differences between both experimental groups concerning all dependent variables except for the rotation ROM.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2017

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

11

Month

03

Day

Last modified on

2017

Year

12

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033836