Effects of sacroiliac mobilization versus high velocity low amplitude thrust manipulation on pain and functional disability in female patients with sacroiliac joint dysfunction: A randomized controlled trial
the aim of study is to compare the effects of mobilization and manipulation on pain and functional disability in female patients with Sacroiliac joint dysfunction and to check whether or not one technique is more effective than other.
Design
two arm parallel group randomized trial with blinded outcome assessment
Settings and conduct
study will be conducted in Islam central hospital Sialkot. it will be double blinded study as the care giver and assessor will be unaware of treatment given
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:
(1)Females from age 25 to 50
(2)Patients with confirmed clinical diagnosis of sacroiliac joint dysfunction
(3)Patients presenting with acute pain from last four weeks in low back or Sacroiliac joint of iliac origin
(4)Patients with the complain of hypomobility of sacroiliac joint.
EXCLUSION CRITERIA:
(1)Patients with vertebral bone pathology,radiculopathy,sciatica, recent fracture
(2)Patients with history of recent surgery in lumbosacral or pelvic area
(3)Pregnant women, or those who had recent infection
(4)Females with history of osteoporosis or cancer
Intervention groups
experimental group 1 will receive mobilization along with routine physical therapy
experiental group 2 will receive manipulation along with routine physical therapy
Main outcome variables
Pain
Functional Disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211117053085N1
Registration date:2021-12-20, 1400/09/29
Registration timing:registered_while_recruiting
Last update:2021-12-20, 1400/09/29
Update count:0
Registration date
2021-12-20, 1400/09/29
Registrant information
Name
Nusrat Qamar
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 52 3544112
Email address
msptm02193002@student.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-04, 1400/05/13
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of sacroiliac mobilization versus high velocity low amplitude thrust manipulation on pain and functional disability in female patients with sacroiliac joint dysfunction: A randomized controlled trial
Public title
Effects of sacroiliac mobilization versus thrust manipulation on pain and functional disability in female patients with sacroiliac joint dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with confirmed clinical diagnosis of sacroiliac joint dysfunction will be included
Patients presenting with acute pain from last four weeks in low back or Sacroiliac joint of iliac origin
Patients with the complain of hypomobility of sacroiliac joint Will be included in our study
Females from age 25 to 50 years will be included in our study
Exclusion criteria:
Patients with vertebral bone pathology,radiculopathy,sciatica, recent fracture will not be included in our study
Patients with history of recent surgery in lumbosacral or pelvic area
Females with history of osteoporosis or cancer or any other bone pathology will not be included
Pregnant women, or those who had recent infection will not be included in our study
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
72
More than 1 sample in each individual
Number of samples in each individual:
5
data will be collected at baseline, 1, 2, 3 and 4 weeks of intervention
Randomization (investigator's opinion)
Randomized
Randomization description
computer generated randomization method will be used to allocate our participants in 2 groups. We will use computer software which will randomly allocate our subjects into either experimental group 1 or experimental group 2. Experimental group 1 will receive Mobilization along with Routine physical therapy while Experimental Group 2 will receive High Velocity Low Amplitude Thrust Manipulation along with routine physical therapy.
Blinding (investigator's opinion)
Double blinded
Blinding description
the care giver and outcome assessor will be unaware of treatment given to participants. We will not disclose to the care giver or the outcome assessor about the type of treatment given to patient. In this way they will be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Lahore
Street address
1km off defence road
City
Lahore
Postal code
54590
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
992
Health conditions studied
1
Description of health condition studied
Sacroiliac joint Dysfunction
ICD-10 code
M46.1
ICD-10 code description
Sacroiliitis, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
outcome will be measured at baseline, 1st, 2nd and 4th weeks post intervention
Method of measurement
pain will be measured using Numeric pain rating scale
2
Description
Functional Disability
Timepoint
Outcome will be measured at baseline, 1st, 2nd and 4th weeks post interventions
Method of measurement
Functional disability will be measured using Oswestry Disability Index Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1 will receive Mobilization along with Routine physical therapy. In routine physical therapy we will use electro therapeutic modalities and simple pelvic stabilization exercises. The intervention will be applied 3 sessions per week for 4 weeks.
Category
Treatment - Other
2
Description
Intervention group: 2 will receive High Velocity Low Amplitude Thrust Manipulation along with routine physical therapy. In routine physical therapy we will use electro therapeutic modalities and simple pelvic stabilization exercises. The intervention will be applied 3 sessions per week for 4 weeks
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
university of Lahore
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
Sialkot college of physical therapy
Full name of responsible person
Dr. Wajida Parveen
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Defence Road Sialkot
City
Sialkot
Province
Punjab
Postal code
51310
Phone
092333507157
Email
wajopri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sialkot College of physical therapy
Full name of responsible person
Nusrat Qamar
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
defence road Sialkot
City
Sialkot
Province
Punjab
Postal code
51310
Phone
0923316678454
Email
dr.nusratqamar55@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sialkot college of physical therapy
Full name of responsible person
Nusrat Qamar
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Defence Road Sialkot
City
Sialkot
Province
Punjab
Postal code
51310
Phone
0923316678454
Email
dr.nusratqamar55@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Effects of Sacroiliac Mobilization versus high velocity low amplitude thrust manipulation on Pain, and functional Disability in female patients with Sacroiliac joint Dysfunction: A randomized controlled trial
All collectedDeidentified IPD will be shared
When the data will become available and for how long
it will be available after the completion of work for three years upon request to the person involved in scientific inquiries
To whom data/document is available
People working in academic institutes or involved in doing research work
Under which criteria data/document could be used
it can be used for citations
From where data/document is obtainable
data can be obtained through email using mail address of dr.nusratqamar55@gmail.com
What processes are involved for a request to access data/document
data can be obtained through e mail to dr.nusratqamar55@gmail.com