Protocol summary
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Study aim
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The effectiveness of adding postural reeducation techniques to the manual therapy on pain, range of motion (ROM) and function of patients with nonspecific chronic neck pain
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Design
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Randomized, controlled clinical trial with a block group design of 32 patients perform .for Block randomization of general posture reeducation was used spss soft ware
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Settings and conduct
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randomized Patients with non-specific chronic neck pain are selected from patients who are refered to physiotherapy clinics. Then, subjects are assigned to two groups of control and intervention according to block randomization.
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Participants/Inclusion and exclusion criteria
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a. Inclusion criteria:
1. Having non specific neck pain for 3 months or more
2. Existence of pain based of VAS more than 3 and 4
3. Age between 18-47
4. Both sex with normal body mass index
5. No smoking habits, have a regular physical activities
b. Exclusion criteria:
1. Limited neck range of motion
2. Night pain
3. No patient satisfaction to participation in study
4. Any radicular pain
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Intervention groups
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Both groups will receive techniques 10 sessions, 45 minute each, according to the participants’ needs. Each group will receive manual therapy.
In control group: This group receives manual therapy techniques that include the release of soft tissue and muscle energy.
In intervention group: This group will receive manual therapy including soft tissue release and muscle energy techniques the same as the control group, Additionally general posture reeducation will add to their treatment program..
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Main outcome variables
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1-Pain
2-Range of motion
3-Funtion
General information
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Reason for update
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Unfortunately, the start date of the patients' recruitment and the end date of the interventions were incorrectly entered and corrected.
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Acronym
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GPRE
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IRCT registration information
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IRCT registration number:
IRCT20210717051912N1
Registration date:
2021-08-28, 1400/06/06
Registration timing:
prospective
Last update:
2022-05-22, 1401/03/01
Update count:
1
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Registration date
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2021-08-28, 1400/06/06
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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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2021-09-07, 1400/06/16
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Expected recruitment end date
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2021-11-21, 1400/08/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effectiveness of adding postural reeducation techniques to the manual therapy of patients with nonspecific chronic neck pain: A Randomized Clinical Trial.
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Public title
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Study of general posture reeducation of exercise on neck pain patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having non specific neck pain for 3 months or more
Existence of pain based of VAS more than 3 and 4
Age between 18-47
Both sex with normal body mass index
No smoking habits, have a regular physical activities
Exclusion criteria:
Limited neck ROM
Night pain
No patient satisfaction to participation in study
Any radicular pain
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Age
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From 18 years old to 47 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
16
16 subjects per group
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The allocation of individuals to the two groups will be by random allocation. Block randomization will be used. The therapist divides people into subgroups called blocks. 8 to four blocks are selected. Individuals in each block are randomly divided into two groups: control (A) and treatment (B). we have 32 per in block each group 16 per in intervention group and 16 per in control group To do this, Excel computer software is used.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2021-07-17, 1400/04/26
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Ethics committee reference number
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IR.USWR.REC.1400.101
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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M95.9
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ICD-10 code description
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Acquired deformity of musculoskeletal system, unspecified
Primary outcomes
1
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Description
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1- pain.
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Timepoint
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Before, after and 2 weeks follow up
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Method of measurement
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Visual analog scale
2
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Description
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2.Range of motion
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Timepoint
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Before, after and 2 weeks follow up
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Method of measurement
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Goniometer
3
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Description
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3.Function
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Timepoint
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Before, after and 2 weeks follow up
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Method of measurement
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Neck disability index questionnaire
Intervention groups
1
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Description
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intervention group: Manual therapy includes: soft tissue release and muscle energy training, in addition to postural re-training techniques added to their treatment program.
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Category
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Rehabilitation
2
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Description
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Control group: This group receives manual therapy such as soft tissue release and muscle energy techniques(MET) .
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Category
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Diagnosis
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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No
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Title of funding source
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university of social welfare and rehabilitation sciences
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Proportion provided by this source
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100
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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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Some of the data, such as information about the consequences, can be shared.
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When the data will become available and for how long
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Starting the access period: 6 months after publition the results.
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To whom data/document is available
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Researchers working in academic and academic institutions.
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Under which criteria data/document could be used
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Only statistical analyzes can be used to find treatment for improvement of patients.
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From where data/document is obtainable
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Applicants can be guided by email authors.
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What processes are involved for a request to access data/document
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First, they will email the authors of the study and we Will be answered within a week.
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Comments
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