Protocol summary

Study aim
The effect of 8 weeks of an exercise battery including stretching, isometric and strengthening exercises on the disability, quality of life, pressure pain intensity and threshold of female employees with non-specific chronic neck pain
Design
24 female employees suffering from non-specific chronic neck pain in Amol city will be randomly divided into two groups (experimental = combined exercises) and (control = no exercises) according to the inclusion and exclusion criteria, and the available sampling method. Participants will be participating at the study for eight weeks.
Settings and conduct
The current research is a clinical trial. All the participants in the intervention group will carry out the exercises for 8 weeks under the supervision of a corrective exercise specialist in person and online at a specific place.
Participants/Inclusion and exclusion criteria
Criteria for entering the research: female employees suffering from non-specific chronic neck pain with an age range between 30 and 55 years - neck pain for more than three months - having general health Exclusion criteria from the research: people who have a history of surgery on the neck - people who have a history of sports and championships - people who have uncontrolled heart disease - people who are suspected and infected with Corona
Intervention groups
Exercise group intervention: The exercises in this exercise intervention is included a series of stretching, isometric and strengthening exercises in the neck, shoulders and shoulders for eight weeks and three sessions per week. Control group intervention: The subjects in the control group will not receive any exercise intervention.
Main outcome variables
Reducing neck muscle pain, reducing shoulder pain, restoring muscle balance by strengthening weakened muscles and stretching shortened muscles, increasing mobility, reducing mechanical load.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201030049193N5
Registration date: 2024-01-18, 1402/10/28
Registration timing: prospective

Last update: 2024-01-18, 1402/10/28
Update count: 0
Registration date
2024-01-18, 1402/10/28
Registrant information
Name
Mahdi Hosseinzadeh
Name of organization / entity
Sport Sciences Research Institute of Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 7714 6478
Email address
metti@ssrc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of an exercise battery including stretching, isometric and strengthening exercises on the disability, quality of life, pressure pain intensity and threshold of female employees with nonspecific chronic neck pain
Public title
The effect of 8 weeks of an exercise battery including stretching, isometric and strengthening exercises on non-specific chronic neck pain
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 30 to 55 years A female employee of Amol city offices Having general health Having chronic neck pain: it means pain that has been going on for three months and has no specific cause.
Exclusion criteria:
Having a regular history of sports and championships Having background and joint diseases Using any kind of medicine or pain reliever and treatment strategy to solve neck pain problems People who are suspected or infected with Corona History of neck surgery Uncontrolled heart disease
Age
From 30 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
People are randomly assigned to one of the two study groups with the help of a table of random numbers and receive the intervention related to the same group
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to create blinding of a blind strain, first, general information regarding how to test and how to perform the exercise will be given to the two groups, and no information will be provided to the controllers in which exercise group and placement. The outcome assessor will be blinded to the group the participants would be assigned.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethic committee of sport sciences research institute of Iran (SSRI)
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-11-22, 1402/09/01
Ethics committee reference number
IR.SSRC.REC.1402.196

Health conditions studied

1

Description of health condition studied
Chronic non-specific neck pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
intensity of pain
Timepoint
Pre-test (before the start of the study) and post-test (at the end of the study)
Method of measurement
Pain intensity variable is measured by visual pain intensity measurement scale.

Secondary outcomes

1

Description
disability
Timepoint
Pre-test (before starting the study) and post-test (at the end of the study)
Method of measurement
Persian neck disability index questionnaire will be used to evaluate functional disability in daily activities.

2

Description
quality of life
Timepoint
Pre-test (before starting the study) and post-test (at the end of the study)
Method of measurement
The short form of the health survey questionnaire will be used to evaluate the quality of life in daily activities.

3

Description
Pressure pain threshold
Timepoint
Pre-test (before starting the study) and post-test (at the end of the study)
Method of measurement
Digital dynamometer will be used for 3-point pain threshold test, pressure pain test and 36-point pain threshold test.

Intervention groups

1

Description
Intervention group: After the pre-tests, they will be entered the training phase. The exercises in this training intervention includes stretching, isometric and strengthening exercises. The exercises consists of a set of movements for 8 weeks, 3 sessions per week, and 1-3 sets, and each set intends for 1-18 repetitions for the subjects. The duration of each session lasts from 45 minutes to 1 hour, the first and last 10 minutes of which includes warming up and cooling down, respectively. The progress in the exercises will be determined based on the pain intensity of each subject.
Category
Treatment - Other

2

Description
Control group: After the pre-tests, this group will be asked not to participate in any training or treatment program.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
North Non-Profit University
Full name of responsible person
Dr. Raheleh Ghafari
Street address
Shomal Faculty of Physical Education and Sports Sciences, Imamzadeh Abdullah crossroads , 5 km of Haraz road , Amol
City
Amol
Province
Mazandaran
Postal code
۸۴۵۹۶-۴۶۱۶۱
Phone
+98 11 4420 3711
Fax
+98 11 4420 3755
Email
rh.ghaffari@gmail.com
Web page address
https://shomal.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Non-Profit University of Shomal
Full name of responsible person
Saeid Fallahian
Street address
Shomal Faculty of Physical Education and Sports Sciences, Imamzadeh Abdullah crossroads , 5 km of Haraz road , Amol
City
Amol
Province
Mazandaran
Postal code
۸۴۵۹۶-۴۶۱۶۱
Phone
+98 11 4420 3756
Fax
Email
s.fallahian1@gmail.com
Web page address
https://shomal.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shomal University
Proportion provided by this source
100
Public or private sector
Private
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
Sport Sciences Research Institute of Iran
Full name of responsible person
Mahdi Hosseinzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Phone
+98 21 8852 9121
Fax
Email
Metti@ssrc.ac.ir
Web page address
https://orcid.org/0000-0001-6019-8205

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sport Sciences Research Institute of Iran
Full name of responsible person
Dr. Mahdi Hosseinzadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport injuries
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Phone
+98 21 7714 6478
Fax
+98 21 8873 9092
Email
metti@ssrc.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Non-Profit University of Shomal
Full name of responsible person
Maryam Habibollahnataj Omran
Position
Student
Latest degree
Master
Other areas of specialty/work
Pathology and corrective movements
Street address
Shomal Faculty of Physical Education and Sports Sciences, Imamzadeh Abdullah crossroads , 5 km of Haraz road , Amol
City
Amol
Province
Mazandaran
Postal code
۸۴۵۹۶-۴۶۱۶۱
Phone
+98 11 4420 3711
Fax
+98 11 4420 3755
Email
maryam.habibnatajj@gmail.com
Web page address
https://shomal.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
There is no more information.
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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