To compare the effects of Post Isometric Relaxation Technique on Pain, Range of Motion
and Quality Of Life in Patients with Gastrocnemius Trigger Points
Design
Randomized Controlled Trial; single-blinded; on 40 samples; parallel groups; randomized by computer-generated method and further concealed envelop method used for allocation in the group. In the envelope, 1 will be code for the control group and 2 will be code for the experimental group.
Settings and conduct
The study will be conducted at the Department of Physical Therapy DHQ Hospital Layyah. The study will be single-blinded. The assessor will unaware of the treatment given to either group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age is between 25-55 years.
Both gender 49
Long standing workers (at least 3-5 hours of standing work including 5-
min seated rest breaks and a 30-min lunch break)
Pre-diagnosed patients of calf pain
NPRS scoring ≤ 4
The presence of at least one trigger point in unilateral gastrocnemius
muscles.
Jump sign positive.
Exclusion Criteria:
Analgesic intake in the past 48 hours
Individuals who are already involved in any exercise program for lower
extremity
Had a previous history of lateral malleolar, bi malleolar or calcaneal
fracture that would affect their gait pattern or strength of the
gastrocnemius
Current pregnancy
Intervention groups
Experimental Physical Therapy Group (B):
Group B will be given Post isometric Relaxation along with routine physical therapy
including hot packs, range of motion exercises, static stretching, and strengthening exercises of
the gastrocnemius muscle. This will be given up to three sessions per week. Post Isometric
Relaxation, Static Stretching, and strengthening exercises will be provided in three repetitions
per session. Each treatment session will have 40-45 minutes duration.
Main outcome variables
pain, range of motion, and Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210321050752N2
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
Muhammad Waqas
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 36532841
Email address
drwaqasfayyaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-07, 1401/09/16
Expected recruitment end date
2023-05-07, 1402/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of post isometric relaxation technique on pain, range of motion and quality of life in patients with gastrocnemius trigger points
Public title
Effects of post isometric relaxation technique in patients with gastrocnemius trigger points
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age is between 25-55 years
Both gender
Long standing workers (at least 3-5 hours of standing work including 5-min seated rest breaks and a 30-min lunch break)
Pre diagnosed patients of calf pain
Numeric pain rating scale (NPRS) scoring ≤ 4
The presence of at least one trigger point in unilateral gastrocnemius muscles.
Jump sign positive. (While compressing the Myofascial Trigger Point, carefully examined the subject’s reaction. A positive jump sign was defined as the subject withdrawing from palpation, wincing, or producingany pain related vocalization)
Exclusion criteria:
Analgesic intake in past 48 hours
Individuals who are already involved in any exercise program for lower extremity
Had a previous history of lateral malleolar, bi malleolar or calcaneal fracture that would affect their gait pattern or strength of the gastrocnemius
Current pregnancy
Age
From 22 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized by using the computer-generated method and further concealed envelop method is used for allocation in the group. In the envelop, 1 will be code for the control group and 2 will be code for the experimental group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor will only assess the patient at baseline and after follow-up for treatment outcomes. Assessor safe the data for follow-up and will not share it with any therapist or patient. At any stage, the assessor is unaware of the treatment and control group. The study was single-blinded. The assessor was unaware of the treatment given to either groups 1 or 2.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The rules and regulations set by the ethical committee of The University of Lahore wIll be followed.
Data will be collected at baseline, 4th week and 8th week (follow-up).
Method of measurement
Numeric pain rating scale to measure pain
2
Description
Quality of Life
Timepoint
Data will be collected at baseline, 4th week and 8th week (follow-up).
Method of measurement
Quality of life is measured by Short Form-12 (SF-12).
3
Description
Range of Motion
Timepoint
Data will be collected at baseline, 4th week and 8th week (follow-up).
Method of measurement
Range of motion is measured by universal goniometer.
Secondary outcomes
empty
Intervention groups
1
Description
Experimental Physical Therapy Group (B):Group B will be given Post isometric Relaxation along with routine physical therapy including hot pack, range of motion exercises, static stretching and strengthening exercises of gastrocnemius muscle .This will be given upto three sessions per week. Post IsometricRelaxation, Static Stretching and strengthening exercises will provided in three repetitions per session. Each treatment session will have 40-45 minutes duration.
Category
Rehabilitation
2
Description
Control group: Routine Physical Therapy Group (A):The routine physical therapy will include hot pack, range of motion exercises, static stretching and strengthening exercises of gastrocnemius muscle .This will be given upto three sessions per week. Hot Pack will be used for 8 minutes in each session. Static Stretching and strengthening exercises will provided into three repetitions per session. Each treatment session will have 30-35 minutes duration.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
DHQ Hospital layyah
Full name of responsible person
Khurram Mehmod
Street address
DHQ layyah college road,layyah punjab
City
Layyah
Postal code
31200
Phone
+92 344 4535304
Email
mehmookhuram8@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Self Supported
Full name of responsible person
Sania Naz
Street address
Major moor chubara road layyah
City
Layyah
Postal code
31200
Phone
+92 304 4407035
Email
sania.naz642@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self Supported
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Muhammad Waqas
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
St# 76, H#09 Muhala Sirajpura Darogawala Shalamar Town Lahore
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
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
Numeric pain rating scale will be used for the assessment of pain and Quality of life-related data.
When the data will become available and for how long
6 months after publication.
To whom data/document is available
academic and clinical research writers.
Under which criteria data/document could be used
Never without permission.
From where data/document is obtainable
From Muhammad Waqas through mail id. drwaqasfayyaz@gmail.com or through a Researchgate account. https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf
What processes are involved for a request to access data/document
From Muhammad Waqas through mail id. drwaqasfayyaz@gmail.com or through a Researchgate account. https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf