•To see the effect of ELDOA technique on pain and disability in text neck syndrome patients.
•To see the effect of sub-occipital muscle inhibition technique on pain and disability in text neck syndrome patients.
•To reduce pain intensity
•To improve range of motion in cervical spine
•To improve functional ability
Design
Randomized Clinical Trial, Two parallel groups.
Settings and conduct
The data was collected from College of Physical Therapy, Government College University Faisalabad Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion criteria
•Age 24 to 40 years
•History of chronic neck pain > 3NRS (for at least 3 months).
•Palpable taut bands in skeletal muscles.
•Reduced cervical ROMs of flexion (<80 degrees), extension (<70degrees), rotation(<90degrees), lateral flexion (<20degrees).
•Developing kyphosis.
•Proper understanding of patient to perform test: tragus to wall test >5cm.
Exclusion criteria
•Surgery of spine or any extremity
•Cervical osteoporosis
•Cervical radiculopathy
•Spinal or upper extremity infection
•Malignancy of upper extremity or thorax
•Obesity
•Trauma or bony deformity of upper extremity
•Dizziness
Intervention groups
Intervention group A:
ELDOA Technique is applied on cervical spine over a period of 4 months. The ELDOA technique will be performed following baseline treatment of hot pack for 7 minutes. The 4 ELDOA positions will be performed such that 1 minutes for each position is assigned.
Intervention group B:
Sub occipital Muscle Inhibition Technique is applied on cervical spine over a period of 4 months. The technique will be performed following baseline treatment of hot pack for 7 minutes. Sub occipital muscle inhibition technique will be performed for 4 minutes.
Main outcome variables
Pain
Cervical spine ROMS
Functional ability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210811052138N6
Registration date:2023-05-18, 1402/02/28
Registration timing:registered_while_recruiting
Last update:2023-05-18, 1402/02/28
Update count:0
Registration date
2023-05-18, 1402/02/28
Registrant information
Name
Halima Shoukat
Name of organization / entity
Riphah international university, Lahore
Country
Pakistan
Phone
+92 55 4284121
Email address
halima.shoukat@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2023-09-15, 1402/06/24
Actual recruitment start date
2023-05-15, 1402/02/25
Actual recruitment end date
2023-09-15, 1402/06/24
Trial completion date
2023-09-15, 1402/06/24
Scientific title
Comparison of the effects of ELDOA Technique and Sub-occipital Muscle Inhibition Technique on pain and disability in patients with Text Next Syndrome.
Public title
Comparison of the effects of ELDOA Technique and Sub-occipital Muscle Inhibition Technique on pain and disability in patients with Text Next Syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
•Age between 24 to 40 years •History of chronic neck pain (for at least 3 months) > 3NRS •Palpable taut bands in skeletal muscles •Reduced cervical ROMs of flexion (<80 degrees), extension (<70degrees), rotation(<90degrees), lateral flexion (<20degrees) •Developing kyphosis •Proper understanding of patient to perform test: tragus to wall test >5cm
Exclusion criteria:
•Surgery of spine or any extremity •Cervical osteoporosis •Cervical radiculopathy •Spinal or upper extremity infection •Malignancy of upper extremity or thorax •Obesity •Trauma or bony deformity of upper extremity •Dizziness
Age
From 24 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were selected by convenient sampling from College of Physical Therapy, Government College University Faisalabad. Each participant was allocated a number on enrollment in the study. Participants were randomly allocated into two groups by a random number sequence generated by a software program called "research randomizer". According to the number generated by a computer software, the participant is allocated into group in which that number falls. This software is used to generate 2 sets of 20 unique numbers via setting the range from 1-40 from least to greatest order.
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 Government College University Faisalabad.
Street address
Government College University, Allama Iqbal Road, Faisalabad Pakistan
City
Faisalabad.
Postal code
38000
Approval date
2023-04-01, 1402/01/12
Ethics committee reference number
GCUF/ERC/2417
Health conditions studied
1
Description of health condition studied
Text Neck Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
This study will improve pain and disability in patients with text neck syndrome
Timepoint
Before intervention and 4 month after intervention
Method of measurement
We will use NDI(neck disability index) and tragus to wall distance test to measure neck disability ,NPRS(numeric pain rating scale) to measure the level of pain intensity.
Secondary outcomes
1
Description
This study will improve the range of motion of involved cervical spine in patients with text neck syndrome.
Timepoint
Before intervention and 4 months after intervention.
Method of measurement
We will use manual goniometer to measure the range of motion of involved cervical spine.
Intervention groups
1
Description
Intervention group A: Treatment with ELDOA technique applied over cervical spine for three times per week over a period of 4 months. This technique will be performed following hot pack for 7 min. The four ELDOA positions will be performed such that 1 min for each position
Category
N/A
2
Description
Intervention group B:Sub occipital Muscle Inhibition Technique is applied on cervical spine over a period of 4 months. The technique will be performed following baseline treatment of hot pack for 7 minutes. Sub occipital muscle inhibition technique will be performed for 4 minutes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
College of Physical Therapy, Government College University, Faisalabad, Pakistan.
Full name of responsible person
Hafiza Noor Tayyab, Raiqa Rafique
Street address
House# P-529, Jinnah Colony, Faisalabad, Pakistan, House no 24-s-14 Kot Gulam Muhammad Khan Kasur, Pakistan
City
Faisalabad.
Postal code
38000, 55050
Phone
+92 323 6682468
Email
hafizanoor01@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Government College University, Faisalabad, Pakistan
Full name of responsible person
Muhammad Abbas
Street address
Government College University, Allama Iqbal Road, Faisalabad Pakistan
City
Faisalabad.
Postal code
38000
Phone
+92 332 6553706
Email
Muhammad.abbas9@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Government College University, Faisalabad, Pakistan
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
Government College University, Faisalabad, Pakistan
Full name of responsible person
Raiqa Rafique
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House no 24-S-14 depot street, Kot Gulam Muhammad Khan Kasur, Pakistan
City
Kasur
Province
Punjab
Postal code
55050
Phone
+92 340 2052901
Email
raiqarafique@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Government College University, Faisalabad, Pakistan
Full name of responsible person
Muhammad Abbas
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Government College University, Allama Iqbal Road, Faisalabad Pakistan
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 332 6553706
Email
Muhammad.abbas9@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Government College University Faisalabad, Pakistan.
Full name of responsible person
Hafiza Noor Tayyab
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
House# P-529, Jinnah Colony Faisalabad, Pakistan
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 323 6682468
Email
hafizanoor01@gmail.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 further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
empty
When the data will become available and for how long
empty
To whom data/document is available
empty
Under which criteria data/document could be used
empty
From where data/document is obtainable
empty
What processes are involved for a request to access data/document