To compare the effects of post isometric relaxation and active release technique on calf muscles tightness in young females.
Design
A Randomized Clinical Trial with two parallel groups, a single- blinded study of third phase with 15 patients in group, which is 30 in total.
Settings and conduct
Subjects were randomly selected from outdoor Patient Department OPD and following clinical setup.
Allied Hospital Faisalabad. Patients were kept unaware about which group they allocated.
Participants/Inclusion and exclusion criteria
• Age group 20-40 • Had symptoms of pain, tightness and functional loss.
• Patient with calf pain VAS moderate(4-7)
• Lower extremity functional scale functional disability due to calf tightness
• Weight bearing wall lunge test positive in patients
• Ankle fracture.
• Pregnancy.
• Deep Vein Thrombosis.
• Medication like cholesterol lowering drugs.
• Compartment syndrome.
• Radiating pain.
• Sports related injury
Intervention groups
Group A of Muscle Energy Technique Group B Active Release Technique
Main outcome variables
1. Pain
2. Ankle Range Of Motion
3. Functional Disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240508061706N1
Registration date:2024-05-29, 1403/03/09
Registration timing:prospective
Last update:2024-05-29, 1403/03/09
Update count:0
Registration date
2024-05-29, 1403/03/09
Registrant information
Name
Zuha Javed
Name of organization / entity
The university of Faisalabad
Country
Pakistan
Phone
+92 308 1358628
Email address
2022-ms-pt-012@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-31, 1403/03/11
Expected recruitment end date
2024-09-30, 1403/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of post Isometric Relaxation and Active Release Technique of calf muscles in young females
Public title
Comparative effect of post Isometric Relaxation and Active Release Technique of calf muscles in young females
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Age group 20-40
• Without any injury of ankle, hip and lower extremity
• Lower extremity functional scale functional disability due to calf tightness
• Weight bearing wall lunge test positive in patients.
• Patient with calf pain VAS moderate(4-7)
Exclusion criteria:
• Sports related injury
• Ankle fracture.
• Deep Vein Thrombosis
• Compartment syndrome.
• Medication like cholesterol lowering drugs.
• Pregnancy.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization done by Lottery method. Participants name and group name along with group number were written on the small paper strips. As the sample size was 30. So 30 small stripes were making and put in a bowl. Then ask the participant to pick one stripes from the bowl. Another person standing along and collect the paper stripes from the participant and opened it and allocates the patient in groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
30 small stripes were making and put in a bowl. Then ask the participant to pick one stripes from the bowl. Another person standing along and collect the paper stripes from the participant and opened it and allocates the patient in groups. participants were blind they have no idea about the allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Ethics/ Technical Committee for 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/MSPP/2024/381
Health conditions studied
1
Description of health condition studied
Calf muscles tightness.
ICD-10 code
M62. 469
ICD-10 code description
Calf muscle, tightness
Primary outcomes
1
Description
Pain
Timepoint
at base line, at every session and end of the total 8 sessions.
Method of measurement
Visual Analog Scale
2
Description
Ankle Range of Motion
Timepoint
At baseline and end of 8th session.
Method of measurement
Universal Goniometer
Secondary outcomes
1
Description
Functional Disability
Timepoint
At base line and end of 8th session
Method of measurement
Lower Extremity Functional Scale(LEFS)
Intervention groups
1
Description
Intervention group: Post Isometric Relaxation
Category
Treatment - Devices
2
Description
Intervention group: Active Release Technique
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Dr. Maryam Safdar
Street address
Dr. Tusi Rd, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 321 7978088
Email
maryam.safdar@tuf.edu.pk
Web page address
https://ahfsd.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University Of Faisalabad
Full name of responsible person
Maryam Safdar
Street address
University Avenue, Faisal Town Canal Road, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 321 7978088
Email
maryam.safdar@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
empty
Country of origin
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
Zuha Javed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
P-310, Khalid-Bin-Waleed road, Umar block, Riaz-ul-Jannah, Daewoo road
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 308 1358628
Email
zuhajaved972@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University Of Faisalabad
Full name of responsible person
Zuha Javed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
P.310, Khalid-Bin-Waleed road, Umar block, Riaz-ul-Jannah, Daewoo road
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 308 1358628
Email
zuhajaved972@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University Of Faisalabad
Full name of responsible person
Zuha Javed
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
P.310, Khalid-Bin-road, Umar block, Riaz-ul-Jannah, Daewoo road
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 308 1358628
Email
zuhajaved972@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
No - There is not 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
Comparative effects of Post Isometric Relaxation and Active Release Technique of calf muscles in young females
When the data will become available and for how long
Starting 6 months after publication. And it will remain available for every one
To whom data/document is available
This will be available for everyone
Under which criteria data/document could be used
maryam.safdar@tuf.edu.pk
00923217978088
From where data/document is obtainable
zuhajaved972@gmail.com
00923081365654
What processes are involved for a request to access data/document
Any applicant just need to contact for data / file. Contact to Email at zuhajaved972gmail.com
00923081365654