Protocol summary

Study aim
The comparison of Manipulation with Mulligan Mobilization on sacroiliac joint dysfunction, disability and range of motion
Design
This study was a double blinded Randomized Clinical Trial. The patients and outcome assessor were blinded about the allocation of the groups.
Settings and conduct
The study was conducted in Evercare Hospital Lahore, outpatient department of physiotherapy.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA: • Patients with sacroiliac joint dysfunction. Screened through provocative sacroiliac joint tests:  Distraction test  Thigh thrust test  Compression test  Sacral thrust test  FABER test  Gaenslen test • Age limit of 20y to 60years • Both male and female, were included in this study. EXCLUSION CRITERIA: • Recent surgical procedure of Lumbar spine • Spondylolisthesis • Lumbar hypermobility • Sacroiliac joint hypermobility • Spinal structural deformity i.e., scoliosis • Severe cardiovascular and bone diseases i.e. tumor
Intervention groups
Patients were randomly distributed to two groups with use of lottery method of randomization. Group A: Patients treating with sacroiliac joint Manipulation, core stability exercises and heating pad. Group B: Patients treating with Mulligan Mobilization, core stability exercises and heating pad.
Main outcome variables
• Numeric pain rating scale (NPRS) • Modified Oswestry disability Questionnaire (MODQ)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210304050573N1
Registration date: 2021-12-29, 1400/10/08
Registration timing: retrospective

Last update: 2021-12-29, 1400/10/08
Update count: 0
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
Idrees Ahmed Zahoor
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 32152273
Email address
idrees911310@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-01, 1399/04/11
Expected recruitment end date
2020-09-30, 1399/07/09
Actual recruitment start date
2020-07-01, 1399/04/11
Actual recruitment end date
2020-10-31, 1399/08/10
Trial completion date
2020-12-31, 1399/10/11
Scientific title
COMPARISON OF MANIPULATION AND MULLIGAN MOBILIZATION IN PATIENTS WITH SACROILIAC JOINT DYSFUNCTION
Public title
COMPARISON OF MANIPULATION AND MULLIGAN MOBILIZATION IN PATIENTS WITH SACROILIAC JOINT DYSFUNCTION
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
• Patients with sacroiliac joint dysfunction. Screened through provocative sacroiliac joint tests: Distraction test Thigh thrust test Compression test Sacral thrust test FABER test Gaenslen test
Exclusion criteria:
Recent surgical procedure of Lumbar spine Spondylolisthesis Lumbar hypermobility Sacroiliac joint hypermobility Spinal structural deformity i.e., scoliosis Severe cardiovascular and bone diseases i.e., tumor
Age
From 20 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 20
More than 1 sample in each individual
Number of samples in each individual: 3
pre-treatment, post-treatment and after 2 weeks
Actual sample size reached: 20
More than 1 sample in each individual
Actual sample size in each individual: 3
pre-treatment, post-treatment and after 2 weeks
Randomization (investigator's opinion)
Randomized
Randomization description
To collect the data non–probability convenience sampling technique was used but all patients were randomly assigned one of two treatment groups by lottery method during research. Patients were randomly distributed to two groups with use of lottery method of randomization. Group A: Patients treating with sacroiliac joint Manipulation, core stability exercises and heating pad. Group B: Patients treating with Mulligan Mobilization, core stability exercises and heating pad.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was a double blinded Randomized Clinical Trial. The patients and outcome assessor were blinded about the allocation of the groups. while the physiotherapist were not blinded.
Placebo
Not used
Assignment
Single
Other design features
Randomized Clinical Trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Riphah College of Rehabilitation & Allied Health Sciences
Street address
28-M, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore, Punjab, Pakistan.
City
Lahore
Postal code
54000
Approval date
2020-03-27, 1399/01/08
Ethics committee reference number
REC/RCRS/20/1053

Health conditions studied

1

Description of health condition studied
SACROILIAC JOINT DYSFUNCTION
ICD-10 code
SACROILIAC
ICD-10 code description
SACROILIAC JOINT DYSFUNCTION

Primary outcomes

1

Description
Pain & Disability
Timepoint
pre-treatment, post-treatment
Method of measurement
• Numeric pain rating scale (NPRS), • Modified Oswestry disability Questionnaire (MODQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients treating with sacroiliac joint Manipulation, core stability exercises and heating pad.
Category
Rehabilitation

2

Description
Intervention group: Patients treating with Mulligan Mobilization, core stability exercises and heating pad.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Evercare Hospital Lahore, outpatient department of physiotherapy.
Full name of responsible person
Dr. Sajid Mehmood
Street address
D1 Commercial, NECHS, Lahore
City
Lahore
Postal code
54000
Phone
+92 300 9452946
Email
drmsajidphy@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University Islamabad
Full name of responsible person
Idrees Ahmed Zahoor
Street address
28-M, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore, Punjab, Pakistan.
City
LAHORE
Postal code
54000
Phone
+92 320 0234583
Email
idrees911310@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
Riphah International University Islamabad
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
Riphah International University Islamabad
Full name of responsible person
Dr. Muhammad Hassim
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
28-M, Quaid-e-Azam, Industrial Estate, Kot Lakhpat, Lahore, Punjab, Pakistan.
City
LAHORE
Province
Punjab
Postal code
54000
Phone
+92 320 0234583
Email
muhammad.hashim@riphah.edu.pk
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Central Park Medical College, Lahore
Full name of responsible person
Idrees Ahmed Zahoor
Position
Senior Lecture
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House # 251 Hassan Block Nishter Colony Ferozepur Road Lahore Pakistan
City
LAHORE
Province
Punjab
Postal code
54000
Phone
+92 320 0234583
Email
idrees911310@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Central Park Medical College, Lahore
Full name of responsible person
Idrees Ahmed Zahoor
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House # 251 Hassan Block Nishter Colony Ferozepur Road Lahore Pakistan
City
LAHORE
Province
Punjab
Postal code
54000
Phone
+92 320 0234583
Email
idrees911310@gmail.com
Web page address

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
By publication of research
When the data will become available and for how long
After publication it will be available
To whom data/document is available
Researcher
Under which criteria data/document could be used
For research and evidence base prectice
From where data/document is obtainable
University
What processes are involved for a request to access data/document
E-mail
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