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Comparison the effect of neck stabilization exercise and dynamic neuromuscular stabilization on pain intensity, forward head angle and muscle activity of employees with chronic non-specific neck pain

Protocol summary

Study aim
The effect of neck stabilization exercise and dynamic neuromuscular stabilization exercise on forward head posture and muscle activity in patients with chronic non-specific neck pain
Design
Retrospective studies with two intervention group and one control group, with parallel groups, double-blind, slot-drawing method, phase 2 on 42 patients
Settings and conduct
In the pre-test, pain intensity, electrical activities (erector spinae, sternocleidomastoid, upper trapezius), head forward angle are measured. Then groups 1 and 2 received a 6-week intervention, while no intervention was performed in the control group. At the end again pain intensity, electrical activities (erector spinae, sternocleidomastoid, upper trapezius), head forward angle are measured. Measurements were performed at Razi University, Kermanshah. Exercises were performed at the Razi University, Kermanshah.
Participants/Inclusion and exclusion criteria
Having persistent neck pain for more than 3 month, Neck pain for which the specialist doctor did not mention a specific cause, No specific structural damage in the neck, women
Intervention groups
The experimental groups received an 6-week corrective exercise (CE) program. The control group was asked to maintain their ordinary daily activities and not to participate in any exercise programs.
Main outcome variables
Pain intensity, forward head angle, electrical activity of upper trapezius neck, sternocleidomastoid, cervical erector spine .

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200622047888N3
Registration date: 2023-11-14, 1402/08/23
Registration timing: retrospective

Last update: 2023-11-14, 1402/08/23
Update count: 0
Registration date
2023-11-14, 1402/08/23
Registrant information
Name
Aynollah Sakinepoor
Name of organization / entity
Kharazmi University, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 83 4522 6103
Email address
asakenapoor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-05-17, 1402/02/27
Actual recruitment start date
2023-05-05, 1402/02/15
Actual recruitment end date
2023-05-17, 1402/02/27
Trial completion date
2023-05-17, 1402/02/27
Scientific title
Comparison the effect of neck stabilization exercise and dynamic neuromuscular stabilization on pain intensity, forward head angle and muscle activity of employees with chronic non-specific neck pain
Public title
neck stabilization and dynamic neuromuscular stabilization exercises and muscle activity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects who had persistent neck pain (more than three months). Subjects who used the computer for at least four hours a day Subjects who got score three from the visual analog scale one week before the pre-test. Subjects who got score between 3 and 7 in the visual pain grading system (scale 0=10 cm). Neck pain for which the specialist doctor did not mention a specific cause Subjects who were female.
Exclusion criteria:
Neck pain for which a specialist doctor has mentioned a specific cause. Specific structural damage in the neck, neck disc Spine surgery
Age
From 32 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Actual sample size reached: 42
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomly assigned to two intervention groups (intervention group one: dynamic neuromuscular stabilization and intervention group two: neck stabilization exercise), and control group by drawing a number from 1 to 54, prepared in advance by the trainer and placed in sealed envelopes in a box. The number envelopes were placed inside a box. The trainer was asked to pick 15 envelopes from the numbers inside the box for each group. The randomization sequence was not disclosed until participants had completed their baseline assessments. The assessor was blinded to group allocation
Blinding (investigator's opinion)
Double blinded
Blinding description
The randomization sequence was not disclosed until patients completed their baseline assessments. The statistician and the assessor were blind to group allocation. Patients were not blind to the interventions (intervention group one: dynamic neuromuscular stabilization and intervention group two: neck stabilization exercise), but did not know which group was the treatment therapy.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
2023-11-02, 1402/08/11

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Hormozgan University of Medical Sciences
Street address
Imam Hossein Street
City
Bandar Abas
Province
Hormozgan
Postal code
7919693116
Approval date
2023-08-04, 1402/05/13
Ethics committee reference number
IR.HUMS.REC.1402.219

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
Electrical activity of muscles
Timepoint
The electrical activity of muscles were measured before and six weeks after the stabilization exercise and dynamic neuromuscular stabilization exercises
Method of measurement
The ground reaction forces is measured by sixteen channel electromyography device

Secondary outcomes

1

Description
Forward head angle
Timepoint
Forward head angle was measured before and after the six the neck stabilization exercise and dynamic neuromuscular stabilization exercises
Method of measurement
Forward head was measured by photogrammetric method.

2

Description
Pain intensity
Timepoint
pain intensity was measured before and after the six the neck stabilization exercise and dynamic neuromuscular
Method of measurement
Pain intensity was measured by the numeric pain rating scale method.

3

Description
Electrical activity of muscles
Timepoint
Electrical activity of muscles was measured before and after the six the neck stabilization exercise and dynamic neuromuscular
Method of measurement
Electrical activity of muscles was measured by electromyography device.

Intervention groups

1

Description
Intervention group1: Intervention group 1: In this group the electrical activity of muscles, pain intensity and forward head angle is respectively measured by electromyography device, the numeric pain rating scale (NPRS), camera respectively. Then Subjects receive neck stabilization exercise for six weeks, and then at the end of the six weeks the electrical activity of muscles is measured again. Training sessions consist of six weeks with three training sessions per week for one hour.
Category
Treatment - Other

2

Description
Intervention group2: Intervention group 2: In this group the electrical activity of muscles, pain intensity and forward head angle is respectively measured by electromyography device, the numeric pain rating scale (NPRS), camera respectively. Then Subjects receive dynamic neuromuscular stabilization exercise for six weeks, and then at the end of the six weeks the electrical activity of muscles is measured again. Training sessions consist of six weeks with three training sessions per week for one hour.
Category
Treatment - Other

3

Description
Control group: The control group was asked to maintain their ordinary daily activities and not to participate in any exercise programs
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi University, Kermanshah
Full name of responsible person
Ainollah Sakinepoor
Street address
Street Hor
City
Eslam Abad Garb
Province
Kermanshah
Postal code
6761753164
Phone
+98 83 4522 6103
Email
asakenapoor@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University, Kermanshah
Full name of responsible person
Ainollah Sakinepoor
Street address
HOR Street
City
Eslam Abad Garb
Province
Kermanshah
Postal code
6761753164
Phone
+98 83 4522 6103
Email
asakenapoor@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
It is a personal financial source
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
The Razi University, Kermanshah
Full name of responsible person
Ainollah Sakinepoor
Position
PhD, sport injury and corrective exercises
Latest degree
Ph.D.
Other areas of specialty/work
Sport injury and corrective exercises
Street address
HOR Street
City
Eslam Abad Garb
Province
Kermanshah
Postal code
6761753164
Phone
+98 83 4522 6103
Email
asakenapoor@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The Razi University, Kermanshah
Full name of responsible person
Ainollah Sakinepoor
Position
PhD, sport injury and corrective exercises
Latest degree
Ph.D.
Other areas of specialty/work
Sport injury and corrective exercises
Street address
HOR Street
City
Eslam Abad Garb
Province
Kermanshah
Postal code
6761753164
Phone
+98 83 4522 6103
Email
asakenapoor@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The Razi University, Kermanshah
Full name of responsible person
Ainollah Sakinepoor
Position
PhD, sport injury and corrective exercises
Latest degree
Ph.D.
Other areas of specialty/work
Sport injury and corrective exercises
Street address
HOR Street
City
Eslam Abad Garb
Province
Kermanshah
Postal code
6761753164
Phone
+98 83 4522 6103
Email
asakenapoor@yahoo.com

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
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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