Comparsion the effectiveness of Muscle Energy techniques with Manipulation in improving the pain and functional ability in Sacroiliac joint dysfunction of postpartum female
To determine the effectiveness of muscle energy techniques versus manipulation in sacroiliac joint dysfunction in postpartum female
Design
A concealed, experimental, blinded, randomized clinical trial with a control group design of 22
patients enrolled between June 2022 and September 2022 and followed for 4 months.
Settings and conduct
This trial will be conducted at Physical Therapy & Rehablitation Ward of Chaudhary Akram Teaching Hospital (Teaching Hospital Associated with Azra Naheed Medical College ,The Superior University ,Lahore)
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Low back pain within six weeks
If they had anterior or posterior innominate dysfunctions and their levels of current pain were at least three by visual analog scale (VAS)
positive gaenslen test subjects were included in this study
age between 20-55 years.
Exclusion Criteria
The patient having a hip fracture.
The subjects had a neurological deficit.
Prolapsed intervertebral disc with or without radiculopathy
True limb length discrepancy
Intervention groups
Group A:The patients of the group were given 10 minutes of the warm-up session using a hot pack. Afterward,
they came in for a muscle energy technique (METS) session.This protocol will be
given to the patient for 8 weeks (4 times per week)
Group B
While Patients in group B were also given
10 minutes of the warm-up session using a hot pack. Later, they came in for a manipulation session.
Then, at the end of the session, both groups (A&B) received pelvic stability exercises. This protocol will be given to the patient for 8 weeks (4 times per week)
Main outcome variables
Pain will be measure visual analog scale and functional ability will be calculated by using Modified Oswestry disability scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220414054537N3
Registration date:2022-07-25, 1401/05/03
Registration timing:prospective
Last update:2022-07-25, 1401/05/03
Update count:0
Registration date
2022-07-25, 1401/05/03
Registrant information
Name
Faisal Ghafoor
Name of organization / entity
The Superior University
Country
Pakistan
Phone
+92 42 38104221
Email address
faisal.ghafoor@superior.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-26, 1401/05/04
Expected recruitment end date
2022-07-30, 1401/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion the effectiveness of Muscle Energy techniques with Manipulation in improving the pain and functional ability in Sacroiliac joint dysfunction of postpartum female
Public title
Effect of muscle energy technique and manipulation in sacroiliac dysfunction Female
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female with low back pain more than 6 weeks
Female patient with anterior and posterior inominate this function and their level of current pain were atleast 3 by visual analog scale
Female with positive Flexion Standing test
Female with Positive gaenslen test
Female age between 20-55
Exclusion criteria:
Patient having the hip fracture
Patient with neurology deficit
Patient with prolapse lntervertebral disc with or without radiculopathy
Patient with limb length discrepancy
Age
From 20 years old to 55 years old
Gender
Female
Phase
1-2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Participants who fulfilled the inclusion criteria were selected convenient sampling technique and were then allocated randomly to Group A and Group B using lottery method. This distribution process is hidden between participants and researchers. This was done by a research assistant who did not participate in any further research
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was double-blinded. The outcome assessor who was blinded to the therapy group was
recruited to take readings at pre-treatment and post-treatment values. And the patients were also
blinded as they didn’t know they all have the same disorder and different techniques had been
given to these patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committe Azra Naheed Centre for Research & Development the Superior University ,Lahore
Street address
Main Riwind Road 17 km ,Lahore
City
Lahore
Postal code
54000
Approval date
2022-06-24, 1401/04/03
Ethics committee reference number
REC/FAHS/DPT/B(AP)/June @2022/994
Health conditions studied
1
Description of health condition studied
Sacroiliac joint dysfunction is a term used to describe the pain of the sacroiliac joint (SI joint). It is usually caused by abnormal motion (i.e. hyper- or hypo-mobile) or malalignment of the sacroiliac joint
ICD-10 code
S33.2
ICD-10 code description
Sacroiliac joint Dysfunction
Primary outcomes
1
Description
Pain
Timepoint
Before the intervention and after the 8 weeks of intervention
Method of measurement
Visual analog scale
2
Description
Functional ability
Timepoint
Before the intervention and after the 8 weeks of intervention
Method of measurement
Modified oswestry scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group A: The patients of the group A were given 10 minutes of the warm-up session using a hot pack. Afterward, they came in for a muscle energy technique (METS) session for 10 minutes. 4 times per week
Category
Rehabilitation
2
Description
Intervention group: Patients in group B were also given 10 minutes of the warm-up session using a hot pack. Later, they came in for a 10 minutes of manipulation session. Then, at the end of the session, both groups (A&B) received pelvic stability exercises. This protocol were given to the patient for 4 weeks (4 times per week)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Chaudhary Akram Teaching Hospital
Full name of responsible person
Gulnaz Yamin
Street address
Main Riwind Road 17 km ,Lahore
City
Lahore
Postal code
54000
Phone
+92 333 6979114
Email
gulnaz.zaheer@superior.edu.pk
Web page address
https://www.superior.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Superior University
Full name of responsible person
Gulnaz Yamin
Street address
17 km Raiwind road Lahore
City
Lahore
Postal code
54000
Phone
+92 333 6979114
Email
Gulnaz.zaheer@superior.edu.pk
Web page address
https://www.superior.edu.pk/
Grant name
Nil
Grant code / Reference number
NIl
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
NIl
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 Superior University
Full name of responsible person
Dr Zohaib Shahid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Main Riwind Road 17 km ,Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 6979114
Email
zohaib.rana@superior.edu.pk
Web page address
https://www.superior.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Superior University
Full name of responsible person
Dr Zohaib Shahid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
17 km Raiwind road Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 6979114
Email
zohaib.rana@superior.edu.pk
Web page address
https://www.superior.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
The Superior University
Full name of responsible person
Dr Faisal Ghafoor
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Rehabilitation management
Street address
17 km Raiwind Road Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 333 4816348
Email
faisal.ghafoor@superior.edu.pk
Web page address
https://www.superior.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
Comparsion the effectiveness of Muscle Energy techniques with Manipulation in improving the pain and functional ability in Sacroiliac joint dysfunction of postpartum female
When the data will become available and for how long
When the trial has been completed after the end july 2022.The data will be available for the future use and after the completion of the trial when it get published approximately after the 3 weeks in the end of the august 2022.The summary will be available after the article get published
To whom data/document is available
It will be available to all teaching institue and hospital for the better cure of the patient and more over it will be avilable for the researcher as well
Under which criteria data/document could be used
Only for the research and for the benefits of the public
From where data/document is obtainable
The Documents will be available on the following details
email.: rehanfaisal68@gmail.com
Contact no: +923334816348
Postal address: Department of Physical Therapy Chaudary Akram Teaching Hospital,The Superior Univeristy Lahore
What processes are involved for a request to access data/document
Application will sent to the email on request rehanfaisal68@gmail.com