Protocol summary

Study aim
To Compare the effects of Maitland Mobilization with and without Muscle Energy Technique in Sacroiliac Joint Dysfunction
Design
Randomised Clinical Trial
Settings and conduct
Aziz Fatima Hospital Faisalabad Madinah Teaching Hospital Faisalabad Allied Hospital Faisalabad
Participants/Inclusion and exclusion criteria
Age 25-45 (Included) Both Males and Females (Included) Pain and Tenderness at Sacroiliajoint (Included) Diagnosed Disc Herniation (Excluded) Pregnant Females (Excluded) Radiating Pain below knee (Excluded)
Intervention groups
Group A (Maitland Mobilization) Group B (Maitland Mobilization +Muscle Energy Technique)
Main outcome variables
Pain Disability Cadence Walking Speed

General information

Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number: IRCT20230706058695N1
Registration date: 2023-09-30, 1402/07/08
Registration timing: retrospective

Last update: 2023-09-30, 1402/07/08
Update count: 0
Registration date
2023-09-30, 1402/07/08
Registrant information
Name
Amna Tariq
Name of organization / entity
The university of Faisalabad
Country
Pakistan
Phone
+92 41 8750971
Email address
amnaf7647@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-28, 1402/01/08
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
2023-03-28, 1402/01/08
Actual recruitment end date
2023-06-30, 1402/04/09
Trial completion date
2023-07-16, 1402/04/25
Scientific title
Comparative effects of Maitland Mobilization with and without Muscle Energy Technique in Sacroiliac joint dysfunction
Public title
Comparative effects of Maitland Mobilization with and without Muscle Energy Technique in Sacroiliac joint dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain and tenderness at sacroiliajoint Low back pain and gluteal\buttock pain from last 3 months 3 or more positive pain provocative tests Having Pain both unilaterally and Bilaterally Minimum 3 pain level on VAS (0-10 on VAS)
Exclusion criteria:
Radiating pain below the knee Vertebral Fracture Diagnosed Disc Herniation Nerve Root Irritation Pregnant females Diagnosed Tumors and Malignancy
Age
From 25 months old to 45 months old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 38
Actual sample size reached: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Computer Generated method where randomisation is done by computer software program and random numbers sequence is generated in two groups where each participant had equal chance of being allocated in group.
Blinding (investigator's opinion)
Single blinded
Blinding description
participant were blinded where they had no idea in which treatment group they are being treated because it can influence their behaviours and outcome.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Amna tariq
Secondary trial Id
amnaf7647@gmail.com
Registration date
2023-02-03, 1401/11/14

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of The University of Faisalabad
Street address
House no 210 Green town Faisalabad Pakistan
City
Faisalabad
Postal code
14496-14535
Approval date
2023-02-03, 1401/11/14
Ethics committee reference number
TUF/ADDI REG/SB/358

Health conditions studied

1

Description of health condition studied
Sacroiliacjoint Dysfunction patients and Low back Pain and Muscle Energy Technique And Maitland Mobilization
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain in Visual Analogue Scale
Timepoint
3 days in week for 4 week
Method of measurement
0-10 scale on paper of VAS

Secondary outcomes

1

Description
Disability with Oswestry Disability Index
Timepoint
2 times 1st at the start of session and 2nd at the last treatment session
Method of measurement
ODI Questionnaire

2

Description
Cadence with Digital Pedometer
Timepoint
2 times 1st at the start of session and 2nd at the last treatment session
Method of measurement
One minute Walk

3

Description
Walking Speed with Digital Pedometer
Timepoint
2 times 1st at the start of session and the 2nd at the last treatment session
Method of measurement
One minute walk

Intervention groups

1

Description
Intervention group A : Moist Hot pack for 15 minutes then Maitland Mobilization of grade 1,2,3 and 4 of 30 repititions in one set and then Strengthening Exercises (isometric adduction and abduction+ bridges + trunk side rotations)
Category
Treatment - Other

2

Description
Intervention group B : Moist Hot pack for 15 minutes then Maitland Mobilization of grade 1,2,3 and 4 of 30 repititions in one set then Muscle Energy Technique for Hamstring, Iliopsoas,Piriformis,Erector spinae and Quadratus Lumborum Muscle and then Strengthening Exercises ( Isometric adduction and abduction + Bridges + trunk side rotations)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Madinah Teaching Hospital
Full name of responsible person
Dr Mariam Mehmood
Street address
Madinah Teaching Hospital Sargodha Road Faisalabad
City
Faisalabad
Postal code
092
Phone
+92 41 8869861
Email
ms.mth@mth.org.pk
Web page address
https://mth.org.pk/

2

Recruitment center
Name of recruitment center
Aziz Fatima Hospital Faisalabad
Full name of responsible person
Dr Basit Mehmood
Street address
Gulistan Colony Raja Road Faisalabad Pakistan
City
Faisalabad
Postal code
38610
Phone
+92 41 8780910
Fax
+92 41 8862131
Email
marketing@afh.com.pk
Web page address
http://afh.com.pk

3

Recruitment center
Name of recruitment center
Allied Hospital Faisalabad
Full name of responsible person
Dr.Sobia
Street address
Jail Road Adjacent to Faisalabad Medical University Near Sargodha Road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210082
Email
ms@alliedhospital.com.pk
Web page address
http://pmc.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Amna Tariq
Street address
Faisal Garden Amin Town Canal Road Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 308 2636971
Email
amnaf7647@gmail.com
Web page address
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
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
PK
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
Dr Mariam Mehmood
Position
Senior Lecturer / Clinical Coordinater
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madinah Teaching Hospital Sargodha Road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 301 4223896
Email
mariam.mehmood@tuf.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Mariam Mehmood
Position
Senior Lecturer/Clinical Coordinater
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madinah Teaching Hospital Sargodha road Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 301 4223896
Email
mariam.mehmood@tuf.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Amna Tariq
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 210 Green town Faisalabad Pakistan
City
Faisalabad
Province
Punjab
Postal code
14496-14535
Phone
+92 308 2636971
Email
amnaf7647@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
personal data of participants
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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Comparative Effects of Maitland Mobilization with and without Muscle Energy Technique in Sacroiliac Joint Dysfunction
When the data will become available and for how long
From April 2023
To whom data/document is available
To persons working in academic institutions and clinical settings
Under which criteria data/document could be used
Data will be available to researchers with valid affiliation to institution
From where data/document is obtainable
amnaf7647@gmail.com
What processes are involved for a request to access data/document
Inquirer must provide cover letter stating their reason to obtain data for their research
Comments
My Research will be beneficial for the researchers regarding low back pain specially to distinguish it from other pathologies like sacroiliajoint dysfunction in my research.
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