History
# Registration date Revision Id
2 2022-05-17, 1401/02/27 227065
1 2021-08-28, 1400/06/06 195474
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  • General information

    2021-08-07, 1400/05/16
    2021-09-07, 1400/06/16
    2021-08-21, 1400/05/30
    2021-11-21, 1400/08/30
    empty
    Unfortunately, the start date of the patients' recruitment and the end date of the interventions were incorrectly entered and corrected.
    empty
    متاسفانه تاریخ شروع فراخوانی بیماران و تاریخ اتمام انجام مداخلات به اشتباه وارد شده بود که اصلاح شد.
  • Recruitment centers

    #1
    Name of recruitment center - English: کلینیک فیزیوتراپی پاس وکلینیک ارتوپدی دکتر رشادی
    Name of recruitment center - Persian: pas clinic and doctor reshadi klinic
    Full name of responsible person - English: حبیب رشادی و مصتفی بذرفکن
    Full name of responsible person - Persian: habib reshadi and mostafa bazrafkan
    Street address - English: east ferdows blvd/no 281 1 floor
    Street address - Persian: بلوار فردوس شرق پ 281 ط 1 کلینیک پاس 4
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1481645371
    Phone: +98 21 4495 2198
    Fax:
    Email: fatmayeniyol1995@gmail.com
    Web page address:
    Name of recruitment center - English: Private physiotherapy clinic
    Name of recruitment center - Persian: کلینیک فیزیوتراپی خصوصی
    Full name of responsible person - English: Mustafa Bazrafkan
    Full name of responsible person - Persian: مصطفی بذرافکن
    Street address - English: East Ferdows Boulevard No. 281, 1st floor, Pass Clinic
    Street address - Persian: بلوار فردوس شرق پ 281 طبقه 1 کلینیک پاس
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1481645371
    Phone: +98 21 4495 2198
    Fax:
    Email: fatmayeniyol1995@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: clinic orthopedics dr reshadi
    Name of recruitment center - Persian: کلینیک ارتوپدی دکتر رشادی
    Full name of responsible person - English: habib reshadi
    Full name of responsible person - Persian: حبیب رشادی
    Street address - English: poonek mirzababaei blvd.imam hasan ave.4 floor
    Street address - Persian: پونک میرزابابیی بلوار. کوچه امام حسن ط 4
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1481645371
    Phone: +98 21 4601 0929
    Fax:
    Email: fatmayeniyol1995@gmail.com
    Web page address:
    Name of recruitment center - English: Orthopedic Clinic
    Name of recruitment center - Persian: کلینیک ارتوپدی
    Full name of responsible person - English: Dr Habib reshadi
    Full name of responsible person - Persian: دکتر حبیب رشادی
    Street address - English: Punak Blvd. Mirzababaei. Imam Hassan Alley, 4th floor
    Street address - Persian: پونک. بلوار میرزابابایی. کوچه امام حسن طبقه 4
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1481645371
    Phone: +98 21 4601 0929
    Fax:
    Email: fatmayeniyol1995@gmail.com
    Web page address:

Protocol summary

Study aim
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
Design
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
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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..
Main outcome variables
1-Pain 2-Range of motion 3-Funtion

General information

Reason for update
Unfortunately, the start date of the patients' recruitment and the end date of the interventions were incorrectly entered and corrected.
Acronym
GPRE
IRCT registration information
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
Registration date
2021-08-28, 1400/06/06
Registrant information
Name
Fatma Yeniyol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 7357
Email address
fatmayeniyol1995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-07, 1400/06/16
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of adding postural reeducation techniques to the manual therapy of patients with nonspecific chronic neck pain: A Randomized Clinical Trial.
Public title
Study of general posture reeducation of exercise on neck pain patients
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 47 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 32
More than 1 sample in each individual
Number of samples in each individual: 16
16 subjects per group
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
Ethics Committee of the University of Social Welfare and Rehabilitation Sciences
Street address
Daneshjoo Blvd., Koodkiar Alley, University of Social Welfare and Rehabilitation Sciences
City
tehran
Province
Tehran
Postal code
1481645371
Approval date
2021-07-17, 1400/04/26
Ethics committee reference number
IR.USWR.REC.1400.101

Health conditions studied

1

Description of health condition studied
non specific chronic neck pain
ICD-10 code
M95.9
ICD-10 code description
Acquired deformity of musculoskeletal system, unspecified

Primary outcomes

1

Description
1- pain.
Timepoint
Before, after and 2 weeks follow up
Method of measurement
Visual analog scale

2

Description
2.Range of motion
Timepoint
Before, after and 2 weeks follow up
Method of measurement
Goniometer

3

Description
3.Function
Timepoint
Before, after and 2 weeks follow up
Method of measurement
Neck disability index questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: Manual therapy includes: soft tissue release and muscle energy training, in addition to postural re-training techniques added to their treatment program.
Category
Rehabilitation

2

Description
Control group: This group receives manual therapy such as soft tissue release and muscle energy techniques(MET) .
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Private physiotherapy clinic
Full name of responsible person
Mustafa Bazrafkan
Street address
East Ferdows Boulevard No. 281, 1st floor, Pass Clinic
City
tehran
Province
Tehran
Postal code
1481645371
Phone
+98 21 4495 2198
Email
fatmayeniyol1995@gmail.com

2

Recruitment center
Name of recruitment center
Orthopedic Clinic
Full name of responsible person
Dr Habib reshadi
Street address
Punak Blvd. Mirzababaei. Imam Hassan Alley, 4th floor
City
tehran
Province
Tehran
Postal code
1481645371
Phone
+98 21 4601 0929
Email
fatmayeniyol1995@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
dr.hamid reza khoramkhorshid
Street address
Daneshjoo Blvd., Koodkiar Alley, University of Social Welfare and Rehabilitation Sciences
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2822
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
university of social welfare and rehabilitation sciences
Proportion provided by this source
100
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Mosallanezhad
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Daneshjoo Blvd., Koodkiar Alley, University of Social Welfare and Rehabilitation Sciences
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2895
Email
zmosallanezhad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra Mosallanezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Daneshjoo Blvd., Koodkiar Alley, University of Social Welfare and Rehabilitation Sciences
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2895
Email
Zmosallanezhad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Zahra mosallanezhad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Daneshjoo Blvd., Koodkiar, University of Social Welfare and Rehabilitation Sciences
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7173 2895
Email
zmosallanezhad@yahoo.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
Some of the data, such as information about the consequences, can be shared.
When the data will become available and for how long
Starting the access period: 6 months after publition the results.
To whom data/document is available
Researchers working in academic and academic institutions.
Under which criteria data/document could be used
Only statistical analyzes can be used to find treatment for improvement of patients.
From where data/document is obtainable
Applicants can be guided by email authors.
What processes are involved for a request to access data/document
First, they will email the authors of the study and we Will be answered within a week.
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