Comparative Effects Of Elongation Longitudinaux Avec Decoaption Osteo Articulaire Versus Upper Thoracic Mobilization And Mobility Exercise For Treatment of Forward Head Posture
To determine comparative effectiveness of Elongation Longitudinaux Avec Decoaptation Osteo Articulaire and upper thoracic mobilization and mobility exercises for treatment of Forward head posture
Design
Study Design: Parallel Two-Group Randomized Clinical Trial
Total sample size: 36
Randomization:
Participants will be randomly assigned to either the ELDOA group or the upper
thoracic mobilization group using a computer-generated sequence.
Settings and conduct
Controlled clinical trial was conducted at GOVT TEACHING HOSPITAL GM ABAD, Faislabad.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Both Gender, Age 20 to 40 years
Patients having FHP
Patients having CVA less than 50.
Pain more than 3 on NPRS scale with FHP
Exclusion Criteria:
History of whiplash injury within 3 months of examination.
History of tumor
History of surgery of cervical or thoracic spine.
Positive neurological signs
Congenital deformity
Intervention groups
Parallel Two-Group Randomized Controlled Trial, Group A received ELDOA exercise. firstly hot pack was applied for 7-8 mins after that participants was explained specific body movements . Four ELDOA position shows to the participants was asked to make these positions and maintained each position for 1 min. .Group B received upper thoracic mobilization and mobility exercise.
Main outcome variables
primary outcome measure :
Craniovertebral angle
Secondary outcome measure:
NDI
NPRS
Cervical range of motions
General information
Reason for update
Acronym
ELDOA,FHP
IRCT registration information
IRCT registration number:IRCT20240525061892N1
Registration date:2024-06-22, 1403/04/02
Registration timing:registered_while_recruiting
Last update:2024-06-22, 1403/04/02
Update count:0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Faiza Khalid
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 336 6669438
Email address
physiofai@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-15, 1403/02/26
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effects Of Elongation Longitudinaux Avec Decoaption Osteo Articulaire Versus Upper Thoracic Mobilization And Mobility Exercise For Treatment of Forward Head Posture
Public title
Comparative Effects Of ELDOA Versus Upper Thoracic Mobilization And Mobility Exercise For Treatment of FHP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both males and females.
Age between 20 to 40 years.
Patients have complained of neck pain.
Patients having forward head posture.
Patients having limited Cervical range of motion.
Patients having Craniovertebral angle CVA less than 50.
Pain more than 3 on NPRS scale with FHP.
Exclusion criteria:
History of whiplash injury within 3 months of examination.
History of tumor
History of surgery of cervical or thoracic spine.•
Positive neurological signs•
Patients having pathology and infection in spine.
• Patients having severe osteoporosis
Congenital deformity
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
participants were allocated into two groups, using lottery methods. The lottery method for randomization is a straightforward technique used in this research to ensure unbiased group assignments. To implement this method, we first defined the groups required for the study. An equal number of tickets were prepared for each group, ensuring the total number of tickets matched the number of participants. All the tickets were then placed into a container and mixed thoroughly to ensure randomness. Each participant drew a ticket from the container, and their assignment to the indicated group was recorded. This method ensures fairness and simplicity, making it suitable for small to medium-sized samples. However, it requires careful execution to avoid human error and may not be practical for very large samples. This approach maintains the integrity of randomization, which is crucial for the validity of experimental results.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Study Design: Parallel Two-Group Randomized Controlled Trial, Group A (ELDOA): Specific ELDOA exercises for FHP Group B (UpperThoracic Mobilization): Exercises targeting thoracic mobility and FHP
Secondary Ids
1
Registry name
Clinical trials.gov
Secondary trial Id
NCT06440720
Registration date
2024-05-31, 1403/03/11
Ethics committees
1
Ethics committee
Name of ethics committee
RESEARCH AND ETHICS / TECHNICAL COMMITTEE/ The University of Faisalabad
Street address
University Avenue, Faisal Town Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Approval date
2024-02-17, 1402/11/28
Ethics committee reference number
TUF/DR/SA/MSPT/2024/380
Health conditions studied
1
Description of health condition studied
Forward Head Posture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
CVA, Craniovertebral angle
Timepoint
Before intervention, 2, 4 weeks after intervention
Method of measurement
Calculated using each participant's profile photo. The self-balanced posture assessment method was used to force the participants to maintain their typical head posture. By drawing a vertical line from Targus to the seventh cervical vertebrae and a horizontal line across them, the angle between them may be calculated to determine the CVA angle.
Secondary outcomes
1
Description
Ranges of neck movements ( CROM) cervical flexion, extension, right Side bending, left Side bending, right rotation and left rotation were measured using a goniometer
Timepoint
before intervention and 2, 4 weeks after intervention
Method of measurement
using a goniometer
2
Description
The NPRS (Numeric Pain Rating Scale)
Timepoint
before intervention and 2, 4 weeks after intervention
Method of measurement
The NPRS scale, which has good reliability and validity in prior research, was utilized to measure the degree of present pain. It consists 11 points that range from 0 to 10.
3
Description
NDI (Neck Disability Index)
Timepoint
before intervention and 2, 4 weeks after intervention
Method of measurement
The Neck Disability Index (NDI) is a 10-item questionnaire designed to provide information about how neck discomfort affects an individual's capacity to carry out activities of daily living.
Intervention groups
1
Description
Intervention Group A . Group A will receive Elongation Longitudinaux Avec Decoaption Osteo Articulaire (ELDOA) exercises. At first hot pack will applied for 7-8 mins after that participants will explain specific body movements . Four ELDOA position will once show to the participants than ask them to make these positions. Once they make these positions stop watch will be set for 1 minute for each position. The positions will apply for three times per week for four week. Each session will take 20-25 mins
Category
Other
2
Description
Intervention Group B:Group B will receive Upper Thoracic Mobilization and thoracic mobility exercises. At first hot pack will applied for 7-8 mins after that, The Participant will prone position and physiotherapist will stand toward the side where mobilization will be applied. The index and middle finger of the left hand of the physiotherapist will be placed on the vertebral transverse process of the participants to the caudal side. The lateral side of the palm of right hand place over left hand index and middle finger and then applies thoracic mobilization toward ventral to caudal direction. After thoracic mobilization thoracic mobility exercise will be perform, participant will ask to put both hand on cervical spine and slowly lift his upper body, until gaining the feeling that the occipital bone pushed upward after moving the chin inward
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faisalabad Teaching Hospital III Ghulam Muhammad Abad
Full name of responsible person
Faiza Khalid
Street address
C2RW+W77, Block C Ghulam Muhammad Abad, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 9330323
Email
physiofai@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Faiza Khalid
Street address
Faisal Town, West Canal Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 333 8969426
Email
2022-ms-pt-009@tuf.edu.pk
Web page address
https://tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Faisalabad
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr. Mahvish Musharaf
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal Town, West Canal Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8868326
Fax
+92 41 8868220
Email
studentaffairshsw@tuf.edu.pk
Web page address
https://tuf.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Faiza Khalid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faisal Town, West Canal Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8750971
Fax
+92 41 8750970
Email
2022-ms-pt-009@tuf.edu.pk
Web page address
https://tuf.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Faiza Khalid
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faisal Town, West Canal Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8750971
Fax
+92 41 8750970
Email
2022-ms-pt-009@tuf.edu.pk
Web page address
https://tuf.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
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
IPD collected for the primary outcome measure only
When the data will become available and for how long
After the completion of Study. In October 2024
To whom data/document is available
With academic researchers.
Under which criteria data/document could be used
For only the purpose of Research
From where data/document is obtainable
physiofai@gmail.com
faiza khalid
What processes are involved for a request to access data/document
An email request describing the purpose of study, with complete evidence showing person doing academic research.