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The Effects of 12 Weeks of Neck Stabilization, Core Stabilization Exercises and Combined Protocol on Pain and Disability in elderly people with Chronic Non-Specific Neck Pain in Tehran city

Protocol summary

Study aim
Determining the effect of 12 weeks of neck stability training, central and combined stability on pain and disability of non-specific chronic neck pain among elderly people in Tehran
Design
The clinical trial has no control group and includes 3 intervention groups, community based and pragmatic, with parallel groups, randomized therapies. The randomization was done by random numbers and the sample size was 103. The sample size before exercise was 106.
Settings and conduct
The present study is a semi-experimental and applied field-based method. First, nonspecific chronic neck pain patients were enrolled from nursing centers in 22 areas of Tehran. The practice protocol will be such that the exercise sessions under the supervision of a physiotherapist will be done one day in a 12-week session per 25 to 30 minutes.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients volunteering in nursing homes, people over 60 years of age, having full vigilance, experiencing chronic non-bad pain, ability to converse in Persian, and not having vision and hearing problems with a score of more than 3 pain will be included in the study. exclusion criteria: Patients with history of neck surgery, psychological, cardiovascular, neurological, neurological, incomplete course of treatment, simultaneous use of other therapies, exacerbation of pain and disability symptoms by exercises, harmfulness of practice with doctor's diagnosis
Intervention groups
1. A group of exercises dedicated to the stability of the neck 2. Special stability training group 3. Combined exercise group
Main outcome variables
Neck Pain; neck disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180412039280N2
Registration date: 2019-03-27, 1398/01/07
Registration timing: retrospective

Last update: 2019-03-27, 1398/01/07
Update count: 0
Registration date
2019-03-27, 1398/01/07
Registrant information
Name
mohsen poursadeghiyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0084
Email address
mo.poursadeghiyan@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-08-11, 1396/05/20
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2017-09-23, 1396/07/01
Trial completion date
2017-09-23, 1396/07/01
Scientific title
The Effects of 12 Weeks of Neck Stabilization, Core Stabilization Exercises and Combined Protocol on Pain and Disability in elderly people with Chronic Non-Specific Neck Pain in Tehran city
Public title
The Effects of 12 Weeks of Neck Stabilization, Core Stabilization Exercises and Combined Protocol on Pain and Disability in Subjects with Chronic Non-Specific Neck Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients volunteering in nursing homes people over 60 years of age having full vigilance experiencing chronic non-bad pain ability to converse in Persian not having vision and hearing problems with a score of more than 3 pain
Exclusion criteria:
Patients with a history of neck surgery mental illness cardiovascular disease neurological diseases failure to complete treatment courses simultaneous use of other therapies (such as massage etc.) exacerbation of pain and disability symptoms by exercising harmful exercise therapy for the individual The diagnosis of a specialist doctor
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 106
Actual sample size reached: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
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 University of social welfare and rehabilitation sciences
Street address
University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2017-07-17, 1396/04/26
Ethics committee reference number
IR.USWR.REC.1396.156

Health conditions studied

1

Description of health condition studied
Nonspecific chronic neck pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
1- pain among non-specific chronic neck pain among elderly people in Tehran.
Timepoint
pain was evaluated just before exercise, eighth week of exercise and 1 week after end of exercise period.
Method of measurement
Pain Detection Questionnaire, Visual Analogue Scale

2

Description
2.1- Disability among non-specific chronic neck pain among elderly people in Tehran.
Timepoint
disability was evaluated just before exercise, eighth week of exercise and 1 week after end of exercise period.
Method of measurement
Neck Disability Assessment Questionnaire, Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Central stability training group: 6 patients trained for central stability exercise for 12 week by physiotherapist
Category
Rehabilitation

2

Description
Intervention group2: Neck Stability Exercise: In this group, six patients underwent training for physiotherapists of central fitness exercises extracted from sources for 12 weeks.
Category
Rehabilitation

3

Description
Intervention group 3: Combined exercises: involving neck stability exercises and central stabilization exercises. In this group, 6 patients underwent training for physiotherapists of central fitness exercises extracted from sources for 12 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Center of Kahrizak
Full name of responsible person
Mohsen Poursadeghiyan
Street address
Dr. Hakim Zad Blvd, The old road of Qom, Kahrizak
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0043
Email
poursadeghiyan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Ahmad Ali Akbari Kamrani
Street address
University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0153
Email
poursadeghiyan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Reza Nabi amjad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Karaj University of medical Science, Karaj, Iran
City
karaj
Province
Tehran
Postal code
1985713834
Phone
+98 26 3343 3007
Email
reazamjad8504@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohsen Poursadeghiyan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Health
Street address
University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0043
Email
poursadeghiyan@gmail.com
Web page address
http://poursadeghiyan.uswr.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohsen Poursadeghiyan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Health
Street address
University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., daneshjo Blvd.,Evin,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21222180043
Email
poursadeghiyan@gmail.com
Web page address
http://poursadeghiyan.uswr.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The participant data file will not be published and is confidential.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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