Protocol summary
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Study aim
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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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Design
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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.
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Settings and conduct
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Kharazmi University of Tehran
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Participants/Inclusion and exclusion criteria
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- 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
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Intervention groups
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corrective exercises
corrective exercises with Cognitive Functional exercises
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Main outcome variables
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pain, Kinesiophobia, disability, electromyography and alignment of scapula
General information
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Reason for update
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Adding measurement variables, Record date of completion of trial,Change the blindness of the study
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Acronym
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IRCT registration information
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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
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Registration date
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2019-05-28, 1398/03/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-31, 1398/03/10
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Expected recruitment end date
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2019-07-11, 1398/04/20
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Actual recruitment start date
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2019-05-29, 1398/03/08
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Actual recruitment end date
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2020-02-01, 1398/11/12
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Trial completion date
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2020-03-02, 1398/12/12
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Scientific title
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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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Public title
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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
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 20 years old to 45 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
36
Actual sample size reached:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples are selected according to the criteria for entering the research and are randomly divided into three groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Outcome evaluator and data analyzer are kept blind. The assessor was blinded to the group allocation.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-05-12, 1398/02/22
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Ethics committee reference number
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IR.KHU.REC.1398.011
Health conditions studied
1
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Description of health condition studied
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non-specific Chronic neck pain
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ICD-10 code
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xiii
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ICD-10 code description
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Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
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Description
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pain rate
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Timepoint
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pre and post test
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Method of measurement
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Pain Visual Scale
2
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Description
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Disability
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Timepoint
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pre and post test
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Method of measurement
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Neck Disability Questionnaire
3
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Description
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electromyography
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Timepoint
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pre and post test
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Method of measurement
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Electromyographic Device
4
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Description
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alignment of scapula
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Timepoint
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pre and post test
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Method of measurement
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caliper
5
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Description
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Kinesiophobia
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Timepoint
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pre and post
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Method of measurement
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Tampa Scale for Kinesiophobia
Secondary outcomes
1
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Description
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Scapular kinematics-
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Timepoint
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pre and post tesr
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Method of measurement
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IMU Sensor,
2
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Description
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flexion relaxation phenomenon
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Timepoint
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pre and post test
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Method of measurement
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Electromyographic Device
3
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Description
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Self-efficacy
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Timepoint
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pre and post test
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Method of measurement
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Self-efficacy Questionnaire
4
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Description
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Quality of life
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Timepoint
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pre and post test
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Method of measurement
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SF-36 Questionnaire
5
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Description
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Pain catastrophizing
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Timepoint
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pre and post
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Method of measurement
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Pain catastrophizing Scale
6
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Description
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Self-efficacy for pain management
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Timepoint
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pre and post
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Method of measurement
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Self-efficacy for pain management
7
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Description
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Self-efficacy for physical function
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Timepoint
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pre and post
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Method of measurement
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Self-efficacy for physical function
8
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Description
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Fear-Avoidance Beliefs
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Timepoint
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pre and post
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Method of measurement
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Fear-Avoidance Beliefs Questionnaire (FABQ)
9
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Description
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Depression
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Timepoint
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pre and post
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Method of measurement
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Depression Questionnaire
10
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Description
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Anxiety
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Timepoint
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pre and post
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Method of measurement
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Anxiety Questionnaire
11
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Description
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range of motion of neck
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Timepoint
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pre and post test
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Method of measurement
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IMU Sensor
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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
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Category
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Treatment - Other
3
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Description
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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.).
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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kharazmi University
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Proportion provided by this source
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20
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Only part of the data, such as dependent variables,The average of all samples, can be shared in scientific articles.
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When the data will become available and for how long
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The date of access is September 2019.
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To whom data/document is available
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Personal information is confidential and General outcomes in paper form Available to everyone..
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Under which criteria data/document could be used
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Information is not available to anyone.General outcomes in paper form Available to everyone.
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From where data/document is obtainable
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Noorollah javdaneh
Phone: 09176616415
Email: njavdaneg68@gmail.com
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What processes are involved for a request to access data/document
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Comments
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