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
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General information
2019-07-26, 1398/05/04
2020-02-01, 1398/11/12
20192020-0702-2601 00:00:00
2019-07-27, 1398/05/05
2020-03-02, 1398/12/12
20192020-0703-2702 00:00:00
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 20 to 45 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 -7 in the visual grading system of pain
- Having a disability score score of between 15 and 30 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
Adding measurement variables, Record date of completion of trial,Change the blindness of the study
Acronym
IRCT registration information
IRCT registration number:IRCT20180813040787N1
Registration date:2019-05-28, 1398/03/07
Registration timing:prospective
Last update:2020-06-20, 1399/03/31
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
2019-05-29, 1398/03/08
Actual recruitment end date
2020-02-01, 1398/11/12
Trial completion date
2020-03-02, 1398/12/12
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 -7 in the visual grading system of pain
- Having a disability score score of between 15 and 30 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
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Actual sample size reached:
72
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)
Single blinded
Blinding description
Outcome evaluator and data analyzer are kept blind. The assessor was blinded to the group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
KHARAZMI UNIVERSITY
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
Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
pain rate
Timepoint
pre and post test
Method of measurement
Pain Visual Scale
2
Description
Disability
Timepoint
pre and post test
Method of measurement
Neck Disability Questionnaire
3
Description
electromyography
Timepoint
pre and post test
Method of measurement
Electromyographic Device
4
Description
alignment of scapula
Timepoint
pre and post test
Method of measurement
caliper
5
Description
Kinesiophobia
Timepoint
pre and post
Method of measurement
Tampa Scale for Kinesiophobia
Secondary outcomes
1
Description
Scapular kinematics-
Timepoint
pre and post tesr
Method of measurement
IMU Sensor,
2
Description
flexion relaxation phenomenon
Timepoint
pre and post test
Method of measurement
Electromyographic Device
3
Description
Self-efficacy
Timepoint
pre and post test
Method of measurement
Self-efficacy Questionnaire
4
Description
Quality of life
Timepoint
pre and post test
Method of measurement
SF-36 Questionnaire
5
Description
Pain catastrophizing
Timepoint
pre and post
Method of measurement
Pain catastrophizing Scale
6
Description
Self-efficacy for pain management
Timepoint
pre and post
Method of measurement
Self-efficacy for pain management
7
Description
Self-efficacy for physical function
Timepoint
pre and post
Method of measurement
Self-efficacy for physical function
8
Description
Fear-Avoidance Beliefs
Timepoint
pre and post
Method of measurement
Fear-Avoidance Beliefs Questionnaire (FABQ)
9
Description
Depression
Timepoint
pre and post
Method of measurement
Depression Questionnaire
10
Description
Anxiety
Timepoint
pre and post
Method of measurement
Anxiety Questionnaire
11
Description
range of motion of neck
Timepoint
pre and post test
Method of measurement
IMU Sensor
Intervention groups
1
Description
Intervention group: CORRECTIVE exercise;scapula stabilization exercises were performed with and without resistance. In non-resistance exercises, body weight was used to perform the exercises, and in the exercises with resistance, free weights and elastic bands were used as resistance exercises. . . The CFT aimed at altering the perception of pain consisted of patient education regarding the multidimensional nature of ongoing pain, management of flair-ups, visual and kinesthetic motor imagery , functional training, and mirror feedback . Rest time between each set was 30 seconds and between each exercise one minute.
Category
Treatment - Other
2
Description
Intervention group: CORRECTIVE exercise whit Cognitive Functional exercises;The CFT consisted of patient education regarding the multidimensional nature of ongoing pain, management of flair-ups, visual and kinesthetic motor imagery , functional training, and mirror feedback. The CFT aimed at altering the perception of pain consisted of patient education regarding the multidimensional nature of ongoing pain, management of flair-ups, visual and kinesthetic motor imagery , functional training, and mirror feedback
Category
Treatment - Other
3
Description
Control group: The control group attended a single session where they were instructed in a home exercise program mainly focused on posture during daily task as well as demonstrations of lifting, pushing, pulling tasks as well as office ergonomics (computer placement, chair and desk adjustments etc.).
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.