History
# Registration date Revision Id
4 2020-06-20, 1399/03/31 139743
3 2020-02-01, 1398/11/12 120427
2 2019-10-11, 1398/07/19 107589
1 2019-05-28, 1398/03/07 91779
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Comparison of the effect of corrective exercises with and without Cognitive Functional exercises on pain, Kinesiophobia, disability, electromyography and alignment of scapula in people with chronic neck pain Along with scapular downward rotation syndrome
Design
The statistical population of the present study was men aged 25 to 40 years with chronic neck pain. Among them, subjects with lower scapular swing syndrome were selected according to the criteria of entering the research and randomly divided into three groups: intervention 1 (corrective exercises) , Intervention (2) (corrective exercises with functional cognitive exercises) and control group will be divided.
Settings and conduct
Kharazmi University of Tehran
Participants/Inclusion and exclusion criteria
- People with neck pain for at least three months - Pain amount, gaining a rating between 3 -5 in the visual grading system of pain - Having a disability score score of between 15 and 24 from a functional disability questionnaire - A neck pain that the doctor has not mentioned for a specific reason - People with lower scapular syndrome
Intervention groups
corrective exercises corrective exercises with Cognitive Functional exercises
Main outcome variables
pain, Kinesiophobia, disability, electromyography and alignment of scapula

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180813040787N1
Registration date: 2019-05-28, 1398/03/07
Registration timing: prospective

Last update: 2019-05-28, 1398/03/07
Update count: 3
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Noorollah Jhavdane
Name of organization / entity
Kharazmi university
Country
Iran (Islamic Republic of)
Phone
+98 21 4471 8356
Email address
njavdaneh68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-31, 1398/03/10
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of corrective exercises with and without Cognitive Functional exercises on pain, Kinesiophobia, disability, electromyography and alignment of scapula in people with chronic neck pain Along with scapular downward rotation syndrome
Public title
Comparison of the effect of corrective exercises with and without Cognitive Functional exercises on pain, Kinesiophobia, disability, electromyography and alignment of scapula in people with chronic neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- People with neck pain for at least three months - Pain amount, gaining a rating between 3 -5 in the visual grading system of pain - Having a disability score score of between 15 and 24 from a functional disability questionnaire - A neck pain that the doctor has not mentioned for a specific reason People with scapular downward rotation syndrome
Exclusion criteria:
- Having any history of fracture and surgery in the shoulder joint - Shoulder instability - The presence of any shoulder injury such as shoulder dislocation, tendonitis and frozen shoulder - The kyphosis angle is greater than 50 and less than 20 degrees - The cranio angle is less than 45 degrees and more than 60 degrees - lack of regular participation in training programs for two consecutive sessions and three non-consecutive sessions prolapsed disk with nerve symptoms. - Spinal surgery. - There is a definite structural damage in the neck. - severe mental illnesses.
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected according to the criteria for entering the research and are randomly divided into three groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
KHARAZMI UNIVERCITY
Street address
TEHRAN
City
TEHRAN
Province
Tehran
Postal code
1493944541
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.KHU.REC.1398.011

Health conditions studied

1

Description of health condition studied
non-specific Chronic neck pain
ICD-10 code
xiii
ICD-10 code description
xiii Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
pain rate - disability- Kinesiophobia-electromyography -alignment of scapula
Timepoint
pre and post test
Method of measurement
Pain Visual Scale - Neck Disability Questionnaire, Tampa Motion Scare Questionnaire - Electromyographic Device

Secondary outcomes

1

Description
Scapular kinematics- flexion relaxation phenomenon- Self-efficacy
Timepoint
pre and post tesr
Method of measurement
IMU sensor, electromyographic device-self-efficacy questionnaire

Intervention groups

1

Description
Intervention group: CORRECTIVE exercise
Category
Treatment - Other

2

Description
Intervention group: CORRECTIVE exercise whit Cognitive Functional exercises
Category
Treatment - Other

3

Description
Control group:
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center of Kharazmi University
Full name of responsible person
amir letafat kar
Street address
karaj- University Square-Kharazmi University-Faculty of Physical Education and Sport Sciences
City
karaj
Province
Alborz
Postal code
۴۹۱۱-۱۵۷۱۹
Phone
+98 21 4471 8356
Email
njavdaneh68@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
kharazmi University
Full name of responsible person
amir letafatkar
Street address
تهران
City
tehran
Province
Tehran
Postal code
7595153714
Phone
+98 21 4471 8356
Email
letafatkaramir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
kharazmi University
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
kharazmi University
Full name of responsible person
noorollah javdaneh
Position
-
Latest degree
Ph.D.
Other areas of specialty/work
Sports Rehabilitation
Street address
tehran
City
tehran
Province
Tehran
Postal code
9575153714
Phone
+98 21 4471 8356
Email
njavdaneh68@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
kharazmi University
Full name of responsible person
noorollah javdaneh
Position
Sports Rehabilitation
Latest degree
Ph.D.
Other areas of specialty/work
Sports Rehabilitation
Street address
tehran
City
tehran
Province
Tehran
Postal code
7595153714
Phone
+98 21 4471 8356
Email
njavdaneh68@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
kharazmi University
Full name of responsible person
noorollah javdaneh
Position
Sports Rehab
Latest degree
Ph.D.
Other areas of specialty/work
Sports Rehab
Street address
tehran
City
tehran
Province
Tehran
Postal code
7595153714
Phone
+98 21 4471 8356
Email
njavdaneh68@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as dependent variables,The average of all samples, can be shared in scientific articles.
When the data will become available and for how long
The date of access is September 2019.
To whom data/document is available
Personal information is confidential and General outcomes in paper form Available to everyone..
Under which criteria data/document could be used
Information is not available to anyone.General outcomes in paper form Available to everyone.
From where data/document is obtainable
Noorollah javdaneh Phone: 09176616415 Email: njavdaneg68@gmail.com
What processes are involved for a request to access data/document
-
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