The effectiveness of adding postural reeducation techniques to the manual therapy of patients with nonspecific chronic neck pain: A Randomized Clinical Trial.
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
Acronym
GPRE
IRCT registration information
IRCT registration number:IRCT20210717051912N1
Registration date:2021-08-28, 1400/06/06
Registration timing:retrospective
Last update:2021-08-28, 1400/06/06
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
2021-08-07, 1400/05/16
Expected recruitment end date
2021-08-21, 1400/05/30
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
ethichs committee of university of social welfare and rehabilitation sciences
Street address
bolwar daneshjoo kodekyar uswr university
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
کلینیک فیزیوتراپی پاس وکلینیک ارتوپدی دکتر رشادی
Full name of responsible person
حبیب رشادی و مصتفی بذرفکن
Street address
east ferdows blvd/no 281 1 floor
City
tehran
Province
Tehran
Postal code
1481645371
Phone
+98 21 4495 2198
Email
fatmayeniyol1995@gmail.com
2
Recruitment center
Name of recruitment center
clinic orthopedics dr reshadi
Full name of responsible person
habib reshadi
Street address
poonek mirzababaei blvd.imam hasan ave.4 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.