Protocol summary

Study aim
our study aim to compare the effects of mobilization and strength training on pain and quality of life in patient with forward head posture
Design
A concealed ,randomized ,assesor blind clinical trial with a parallel group design of 34 patient enrolled between from may,2022 to july 2022 for two month,
Settings and conduct
its will conduct in chaduhary akram teaching hospital and this trial is assesor blind
Participants/Inclusion and exclusion criteria
inclusion criteria: Patient with chronic neck pain for more than 3 month Patient with neck disability index less than 24 Patient with prolong sitting workspace enviourment Patient with chronic headache age between 23 to 57 Exclusion criteria En Patient with congenital/acquired postural deformities like scoliosis patient undergone the neck surgeries patient with spinal diseases like compression,tumors,neurological deficits patient with neck fracture and inflammatory disease
Intervention groups
Group A Intervention group: Subjects will told to perform head nodding action to gradually target and hold the 5 pressure levels for 10 seconds between 22 mmHg and 30 mmHg. The minimum satisfactory performance requirements were 26 mmHg. Each session of consisted of 3 sets, with each set having 10 repetitions. Sessions were performed for a total of 6 weeks with 4 days in a week under the supervision of the therapist for total 8 weeks of the total trial Group B Intervention group: will given the mobilization exercises total of three sets will conducted, with one set consisting of repeating the motion that will maintained for 10 s up to 10 times. A break of 5 s will provided per one movement and 30 s per one set. Therefore, the total exercise time will be less <10 min.this treatment will continue for 8 weeks.
Main outcome variables
Pain will be assessed by using Visual analog scale and quality of life will be calculated with Sf36 quality of life scale

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220414054537N2
Registration date: 2022-07-18, 1401/04/27
Registration timing: retrospective

Last update: 2022-07-18, 1401/04/27
Update count: 0
Registration date
2022-07-18, 1401/04/27
Registrant information
Name
Faisal Ghafoor
Name of organization / entity
The Superior University
Country
Pakistan
Phone
+92 42 38104221
Email address
faisal.ghafoor@superior.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-10, 1401/03/20
Expected recruitment end date
2022-06-15, 1401/03/25
Actual recruitment start date
2022-06-13, 1401/03/23
Actual recruitment end date
2022-06-20, 1401/03/30
Trial completion date
2022-08-20, 1401/05/29
Scientific title
Comparsion of the effectiveness of mobilization and strength training in improving pain and quality of life in patient with forward head posture
Public title
effects of mobilization and strength training in patient with forward head posture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with chronic neck pain for more than 3 month Patient with neck disability index less than 24 Patient with prolong sitting workspace enviourment Patient with chronic headache age between 23 to 57
Exclusion criteria:
Patient with congenital/acquired postural deformities like scoliosis patient undergone the neck surgeries patient with spinal diseases like compression,tumors,neurological deficits patient with neck fracture and inflammatory disease
Age
From 23 years old to 57 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 34
Actual sample size reached: 34
Randomization (investigator's opinion)
Randomized
Randomization description
After baseline assessment patients were divided into two groups A and B randomly by gold fish bowl method. Randomization was done by one of the accessors who was not be a part of research and patient treatment. Randomization assignments was kept in opaque, sealed envelopes and was unsealed by researcher after a baseline treatment. After randomization, the participants in the study was only one to be informed about the allocation of program by the therapist, remaining were unaware of the interventions applied in the other group from may,2022 to july 2022 for two month
Blinding (investigator's opinion)
Single blinded
Blinding description
the assesor of the study is blind he will not know about the treatment protocol is given to participants and form which group is belongs
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
committe Azra Naheed Centre for Research & Development the Superior University ,Lahore
Street address
main riwind road 17 km ,Lahore
City
Lahore
Postal code
54000
Approval date
2022-06-24, 1401/04/03
Ethics committee reference number
REC/FAHS/DPT/B/(AP)/June2022/992

Health conditions studied

1

Description of health condition studied
Forward head posture (FHP) is a poor habitual neck posture. It often co-exists with Upper Crossed Syndrome. Defined by hyperextension of the upper cervical vertebrae and forward translation of the cervical vertebrae
ICD-10 code
R29.3
ICD-10 code description
Abnormal posture

Primary outcomes

1

Description
pain
Timepoint
before the start of the intervention and after the 8 weeks of intervention
Method of measurement
pain will be calculated Numeric pain rating scale

2

Description
Quality of life
Timepoint
before the start of the intervention and after the 8 weeks of intervention
Method of measurement
The quality of life will be calculated by using Sf-36 quality of life scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the patient will instructed to target one mark corresponding 2 mmHg on the pressure dial at a time. The pressure that will the patient could hold steady for 10 seconds with minimal superficial muscle activity is the one which take as baseline endurance capacity (10 repetitions of 10-second hold). The action will ensure to be pure nod with no head retraction and no head lifting. Subjects will told to perform head nodding action to gradually target and hold the 5 pressure levels for 10 seconds between 22 mmHg and 30 mmHg. The minimum satisfactory performance requirements were 26 mmHg. Each session of consisted of 3 sets, with each set having 10 repetitions. Sessions were performed for a total of 6 weeks with 4 days in a week under the supervision of the therapist for total 8 weeks of the total trial
Category
Rehabilitation

2

Description
Intervention group: Group B will given the mobilization exercises total of three sets will conducted, with one set consisting of repeating the motion that will maintained for 10 s up to 10 times. A break of 5 s will provided per one movement and 30 s per one set. Therefore, the total exercise time will be less <10 min.this treatment will continue for 8 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
committe Azra Naheed Centre for Research & Development the Superior University ,Lahore
Full name of responsible person
Dr zohaib Shahid
Street address
main riwind road 17 km ,Lahore
City
Lahore
Postal code
54000
Phone
+92 333 6979114
Email
zohaib.rana@superior.edu.pk
Web page address
https://www.superior.edu.pk/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Superior University
Full name of responsible person
Gulnaz Yamin
Street address
17 km Raiwind road Lahore
City
Lahore
Postal code
54000
Phone
+92 333 6979114
Email
Gulnaz.Zaheer@superior.edu.pk
Web page address
https://www.superior.edu.pk/
Grant name
Nil
Grant code / Reference number
NIl
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Nil
Proportion provided by this source
1
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
Committe Azra Naheed Centre for Research & Development the Superior University ,Lahore
Full name of responsible person
Dr Zohaib Shahid
Position
Assiatant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Main Riwind Road 17 km ,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 6979114
Email
Zohaib.rana@superior.edu.pk
Web page address
https://www.superior.edu.pk/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Committe Azra Naheed Centre For Research & Development The Superior University ,Lahore
Full name of responsible person
Dr Zohaib Shahid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Main Riwind Road 17 km ,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 6979114
Email
Zohaib.rana@superior.edu.pk
Web page address
https://www.superior.edu.pk/

Person responsible for updating data

Contact
Name of organization / entity
The Superior University
Full name of responsible person
Dr Faisal Ghafoor
Position
Senior Consultant
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
17 km Raiwind road Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 4816348
Email
faisal.ghafoor@superior.edu.pk
Web page address
https://www.superior.edu.pk/

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
Undecided - It is not yet known if there will be 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
All data will be shared aftere de-identification
When the data will become available and for how long
data will be avilable when the rial has been completed at the end of the august 2022,the data will be avilable for the future use and after the completeion of trial when it get published approximately after 4 week in the start of of october 2022 and summry of the data will be avilable after the article get published
To whom data/document is available
it will be avilable to all teaching institute and hospital for better care of thepatient more over it will be avilable for the researcher as well
Under which criteria data/document could be used
only for the research and for the benefits of public
From where data/document is obtainable
the documents will be avilable on the following details email:rehanfaisal68@gmail.com and contact no: +923334816348, the postal address:Department of physical therapy, chaudhary akram teaching hospital the superior university,17 km riwind road,Lahore
What processes are involved for a request to access data/document
application sent on the email on request rehanfaisal68@gmail.com
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