Comparative Effects of Strain Counterstain and Post-Isometric Relaxation Techniques on Pain, Range of motion and Functional Disability in Patients with Upper Cross Syndrome
To determine the comparative effects of strain counterstain and post-isometric relaxation techniques on pain, range of motion and functional disability in patients with upper cross syndrome.
Design
This study will be Randomized Clinical Trial, parallel-group, triple blinded
Settings and conduct
The Trial would be conducted in District Headquarters DHQ Hospital OKARA City
Participants/Inclusion and exclusion criteria
inclusion criteria
⦁ Individuals with chronic neck pain from > 6 weeks
⦁ Both male and female gender
⦁ Age from 20-40 years
⦁ Neck Pain on > 3 on numerical pain rating scale
⦁ Individuals diagnosed with craniovertebral angle less than 50cm
⦁ Occiput to wall distance greater then 2cm
exclusion criteria
⦁ Subjects who will have signs of recent surgery
⦁ Whiplash injury or open wounds
⦁ Cervical spine pathologies like radiculopathies disc herniation, spondylolisthesis, sensory changes in neck region
⦁ Any neurological defect
Intervention groups
Group A will receive strain counterstain technique; the position of ease will be produced through positioning the muscle in relaxed/ shortened position, ease will be defined as where a reduction in pain at least 70% then, pressure is applied to Trp and it will be held for 90-120 seconds with 3-5 repetitions per treatment session ( three session per week for 3 weeks).
Group B will receive post-isometric relaxation technique with 3-5 muscle contraction at sub maximal pain-free effort (20% of available strength) with 5-7 seconds for 5 repetitions per treatment session (three sessions per week for 3 weeks).
Main outcome variables
Pain;
Range of motion;
Functional disability
General information
Reason for update
Acronym
randomized clinical trial
IRCT registration information
IRCT registration number:IRCT20190717044238N6
Registration date:2023-03-06, 1401/12/15
Registration timing:registered_while_recruiting
Last update:2023-03-06, 1401/12/15
Update count:0
Registration date
2023-03-06, 1401/12/15
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effects of Strain Counterstain and Post-Isometric Relaxation Techniques on Pain, Range of motion and Functional Disability in Patients with Upper Cross Syndrome
Public title
Comparative Effects of Strain Counterstain and Post-Isometric Relaxation Techniques on Pain, Range of motion and Functional Disability in Patients with Upper Cross Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with chronic neck pain from > 6 weeks
Both male and female gender
Age from 20-40 years
Neck Pain on > 3 on numerical pain rating scale
Individuals diagnosed with craniovertebral angle less than 50cm
Occiput to wall distance greater then 2 cm
Exclusion criteria:
Subjects who will have signs of recent surgery
Whiplash injury or open wounds
Cervical spine pathologies like radiculopathies disc herniation, spondylolisthesis, sensory changes in neck region
Any neurological defect
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
As per the inclusion and exclusion criteria of the study , patients will be divided into two groups randomly by Random Number Generator table
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patients taking part in the study would be blinded, they would not be able to know the group they have been allocated to, either Strain Counterstain and Post -Isometric Relaxation Techniques, The assessor of the outcomes would be blinded and lastly, out data analyzer would be blinded too, making it a triple blinded clinical trial
Placebo
Not used
Assignment
Parallel
Other design features
This study will be Randomized Clinical Trial, parallel-group, triple blinded ( patients, assessor and data analyzer will make it triple blinded)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ripah College of Rehabilitation and Allied Health Sciences Lahore
Total intervention protocol will be given for three weeks of duration, 3 sessions per week for three weeks, Outcomes will be assessed at Baseline, at the end of 3 week( last treatment session) and at the end of 6th week
Method of measurement
NDI is the self-report questionnaire that is designed to determine how the neck pain affects a patient’s daily life and the disability of patients with neck pain. It consists of 10 questions that ask about ADLS. More the score, greater was the disability. Sample questionnaire is attached at the end. Four sections relate to subjective symptoms, and the remaining 6 sections relate to activities of daily living. Each section is scored from 0 to 5 points, giving a maximum score of 50. The total score of the NDI ranges from 0 to 50 points
Secondary outcomes
1
Description
Pain
Timepoint
Total intervention protocol will be given for three weeks of duration, 3 sessions per week for three weeks, Outcomes will be assessed at Baseline, at the end of 3 week (last treatment session) and at the end of 6th week
Method of measurement
Patient level of pain will be assessed using Numerical Pain Rating Scale ( NPRS) This scale ranges from 0 to 10. 0 indicates “no pain” and 10 indicates “worst pain”
2
Description
Range of Motion
Timepoint
Total intervention protocol will be given for three weeks of duration, 3 sessions per week for three weeks, Outcomes will be assessed at Baseline, at the end of 3 week (last treatment session) and at the end of 6th week
Method of measurement
Changes from the Baseline ROM range of Motion of Cervical spine will be taken with the Help of universal Goniometer
Intervention groups
1
Description
Intervention group: group A will receive strain counterstain technique; the position of ease will be produced through positioning the muscle in relaxed/ shortened position, ease will be defined as where a reduction in pain at least 70% then, pressure is applied to Trp and it will be held for 90-120 seconds with 3-5 repetitions per treatment session ( three session per week for 3 weeks)
Category
Treatment - Other
2
Description
Intervention group: group B will receive post-isometric relaxation technique with 3-5 muscle contraction at sub maximal pain-free effort (20% of available strength) with 5-7 seconds for 5 repetitions per treatment session (three sessions per week for 3 weeks).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
DHQ hospital Okara
Full name of responsible person
Dr Zaheer Abbas khan
Street address
RC6R+QVF, Eid Gah Rd okara, Punjab
City
okara
Postal code
56300
Phone
+92 322 5536578
Email
zeeokg@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ripah international university
Full name of responsible person
Dr. Fareeha Amjad
Street address
Ripah international university Maddar e Millat Road, Quaid e Azam industrial Estate Lahore, Punjab
City
lahore
Postal code
54000
Phone
+92 334 3372779
Email
fareeha.amjad@ripah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ripah international 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
Ripah international university
Full name of responsible person
Anila Ramzan
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
street 2 house 84 basti rahim buksh jalil town renala khurd
City
okara
Province
punjab
Postal code
56130
Phone
+92 309 0841811
Email
anila.ramzan81@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ripah international university
Full name of responsible person
Dr Fareeha Amjad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ripah international university Madar e Millat Road, Quaid e Azam Industrial Estate Lahore,Punjab
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 334 3372779
Email
Fareeha.amjad@ripah.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Ripah International University
Full name of responsible person
Anila Ramzan
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house 84 street 2 basti rahim buksh jalil town renala khurd district okara
City
Renala khurd district okara
Province
punjab
Postal code
56130
Phone
+92 309 0841811
Email
anila.ramzan81@gmail.com
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
All collected identified IPD
When the data will become available and for how long
Data will be available after the completion of study and will remain available till 6 months
To whom data/document is available
Data will be available for other people almost 6 months after the completion of study
Under which criteria data/document could be used
The data/document could be used by communicating with the principle investigator Hadiqa Naeem on email address hadiqa621@gmail.com
From where data/document is obtainable
Hadiqa Naeem , hadiqa621@gmail.com
What processes are involved for a request to access data/document
The data/document could be used by communicating with the principle investigator Hadiqa Naeem on email address hadiqa621@gmail.com