COMPARATIVE ANALYSIS ON THE EFFECTIVENESS OF MUSCLE ENERGY TECHNIQUE AND MAITLAND MOBILIZATIONS IN THE MANAGEMENT OF CHRONIC SACRO ILIAC JOINT DYSFUNCTION FOR IMPROVING PAIN AND DISABILITY: A RANDOMIZED CONTROL TRIAL
To compare the effectiveness of Muscle Energy Technique with Maitland Mobilizations in patients with chronic Sacroilliac Joint Dysfunction in reducing pain and disability.
Design
A single blind Randomized controlled trial with a parallel group design of 60 patients had random allocation by Chit-Box method.
Settings and conduct
Patients from the Physical-Therapy departments of Khyber Teaching Hospital, Lady Reading Hospital, Peshawar Pakistan. The outcome assessor had been kept blind during the trial.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Age group between 25- 55 years
Both Male and Female patients
Chronic cases of SIJ dysfunction
Patients with at least moderate score (21%-40%) in MODI
Patients with 3 or 4 positive SIJ provocative test
Exclusion Criteria
Patients with LBP or acute discogenic sciatic pain.
Patients who are previously on injections into SI joint.
Piriformis syndrome.
Hip joint pathology
Trochanter pain syndrome
Facet joint arthropathy
Rheumatoid arthritis
Ankylosing spondylitis
Radiculopathy
Visceral referral pain
Stress fracture
Malignancy
Patients with any Co-morbid condition.
Intervention groups
The patients were recruited in two groups i.e. group A and group B by Randomization through Chit-box method. Group-A (Experimental Group) patients had been treated with MET and Lumbopelvic Stability Exercises and Group-B (Control Group) patients had been treated with Maitland Mobilizations and Lumbopelvic Stability Exercises. The patients in both the groups had received a series of twelve treatment sessions and a follow up consultation over a maximum period of four weeks. The readings were taken for two times during the whole session.
Main outcome variables
VAS (Visual Analogue Scale) for measuring the Pain.
MODI (Modified Oswestry Disability Index) for measuring the Disability.
General information
Reason for update
Acronym
SIJD
IRCT registration information
IRCT registration number:IRCT20190618043930N1
Registration date:2019-07-14, 1398/04/23
Registration timing:prospective
Last update:2019-07-14, 1398/04/23
Update count:0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
Faryal Zaidi
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 37592112
Email address
faryal.pt@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2635-09-06, 2014/06/15
Expected recruitment end date
2635-10-22, 2014/07/30
Actual recruitment start date
2635-12-22, 2014/10/01
Actual recruitment end date
2636-03-04, 2014/12/14
Trial completion date
2636-07-21, 2015/04/30
Scientific title
COMPARATIVE ANALYSIS ON THE EFFECTIVENESS OF MUSCLE ENERGY TECHNIQUE AND MAITLAND MOBILIZATIONS IN THE MANAGEMENT OF CHRONIC SACRO ILIAC JOINT DYSFUNCTION FOR IMPROVING PAIN AND DISABILITY: A RANDOMIZED CONTROL TRIAL
Public title
MUSCLE ENERGY TECHNIQUE AND MAITLAND MOBILIZATIONS IN TREATING CHRONIC SACRO ILIAC JOINT DYSFUNCTION
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic cases of Sacro Iliac Joint dysfunction
Patients with at least moderate score (21%-40%) in Modified Oswestry Disability Index
Patients with 3 or 4 positive Sacro Iliac Joint provocative test
Exclusion criteria:
Patients with Low Back Pain or acute discogenic sciatic pain.
Patients who are previously on injections into SI joint
Piriformis syndrome.
Hip joint pathology
Trochanter pain syndrome
Facet joint arthropathy
Rheumatoid arthritis
Ankylosing spondylitis
Radiculopathy
Visceral referral pain
Stress fracture
Malignancy
Patients with any Co-morbid condition.
Age
From 25 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were recruited in two groups i.e. group A and group B by Randomization through Chit-box method. Group-A (Experimental Group) patients had been treated with MET and Lumbopelvic Stability Exercises and Group-B (Control Group) patients had been treated with Maitland Mobilizations and Lumbopelvic Stability Exercises.
Chit-Box Method: For random allocation of 60 cases into two groups equally, prepare 60 chits writing “C” (for Control group) on 30 chits and “E” (for Experimental group) on 30 chits. After folding the chits and putting in a box and well mixing, draw a chit, note the letter written on it, and then draw the second chit without replacing the first, note it and proceed similarly until the last i.e. 60th chit is drawn. The generated random allocation sequence may be one as appears in Table below . According to this sequence the first case registered will go to the control group, second case again to the control group, the third to the experimental group and so on to the last case to control group.
Draw 1st 2nd 3rd -- 15th
Result (Letters on chit) C C E C E C C E C C E E -- E C E C
Registered Case No.
(No. Allocation) 1 2 3 4 5 6 7 8 9 10 11 12 -- 57 58 59 60
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome Assessor has been kept blind during the trial
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Advanced Studies & Research Board of Khyber Medical University
Street address
Block-IV PDA building, Phase-V Hayatabad
City
Peshawar
Postal code
25000
Approval date
2014-09-29, 1393/07/07
Ethics committee reference number
ASRB000223/CA/IPM&R
Health conditions studied
1
Description of health condition studied
The “Sacroiliac Joint (SIJ) Dysfunction” indicates a pain in the SI joint region that is usually caused by either too much movement (hypermobility) or too little movement (hypo mobility) at the joint that typically results in an irritation of the joint. The mechanical SIJ dysfunction typically causes a dull ache that is located at the base of the spine on the affected side. The pain may become worse and 'sharp' in nature during the activities such as sitting, bending, lifting, standing up from a seated position, or lifting the knee up to the chest during stair climbing. Sometimes the pain can refer to the groin, buttock or the back of the thigh but rarely goes below the knee. The patients with severe and disabling SI joint dysfunction can suffer from insomnia and depression.The main causes of SIJ dysfunction are hypermobility i.e. ligamentous laxity and hypomobility i.e. degenerative joint disease, traumatic incident, hormonal imbalance, unilateral weak lower limb, reversal of concavo-convex locking relationship of SI joint, scoliosis, lumbar spinal fusion, spondyloarthropathies, hip osteoarthritis, femoroacetabular impingement, leg-length inequality, poor-quality footwear, biomechanical or muscle length imbalances.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
PAIN
Timepoint
At the start of intervention and then after one month (12 sessions) of treatment administration
Method of measurement
VAS (Visual Analogue Scale) for measuring the Pain.
Secondary outcomes
1
Description
DISABILITY
Timepoint
At the start of intervention and then after one month (12 sessions) of treatment administration.
Method of measurement
MODI (Modified Oswestry Disability Index) for measuring the Disability
Intervention groups
1
Description
Intervention group: Group-A of 30 patients (Experimental group) was treated with Muscle Energy Technique that was applied on Quadratus Lumborum, Illiopsoas and Piriformis muscles of the affected side for 1 set of 5 repetitions with 10 sec hold along with Lumbopelvic stability exercises which were targeted to the ipsilateral gluteus maximus, contralateral latissimus dorsi and abdominals in 3 sets of 10 reps with 10 sec hold.
Category
Treatment - Other
2
Description
Control group: Group-B of 30 patients (Control group) was treated with Sacroiliac Joint Maitland mobilizations in 3 sets of 30 oscillations each on the affected side along with Lumbopelvic stability exercises which were targeted to the ipsilateral gluteus maximus, contralateral latissimus dorsi and abdominals in 3 sets of 10 reps with 10 sec hold.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khyber Teaching Hospital
Full name of responsible person
Dr. Abid Ali
Street address
University Rd, Rahat Abad
City
Peshawar
Postal code
25000
Phone
+92 922 440008
Fax
+92 91 9224423
Email
info@kth.com.pk
Web page address
https://www.kth.gov.pk/
2
Recruitment center
Name of recruitment center
Lady Reading Hospital
Full name of responsible person
Dr. Muhammad Khan
Street address
Hospital Road
City
Peshawar
Postal code
25000
Phone
+92 91 9211441
Fax
+92 91 9211401
Email
info@lrh.gov.pk
Web page address
https://lrh.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
khyber medical university
Full name of responsible person
Dr. Mohammad Bin Afser Jan
Street address
Block-IV, PDA building, Phase-V Hayatabad
City
Peshawar
Postal code
25000
Phone
+92 91 5892885
Email
ipmr@kmu.edu.pk
Web page address
http://www.kmu.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
khyber medical university
Proportion provided by this source
100
Public or private sector
Public
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 University of Lahore
Full name of responsible person
Faryal Zaidi
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Japan Road Sihala
City
Islamabad
Province
Punjab
Postal code
75500
Phone
+92 42 111 865 865
Email
faryal.pt@gmail.com
Web page address
https://www.uol.edu.pk/campuses/islamabadcampus
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Faryal Zaidi
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Japan Road, Sihala
City
Islamabad
Province
Punjab
Postal code
75500
Phone
+92 42 37592112
Fax
Email
faryal.pt@gmail.com
Web page address
https://www.uol.edu.pk/campuses/islamabadcampus
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Faryal Zaidi
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Japan Road, Sihala
City
Islamabad
Province
Punjab
Postal code
75500
Phone
+92 42 37592112
Fax
Email
faryal.pt@gmail.com
Web page address
https://www.uol.edu.pk/campuses/islamabadcampus
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
there is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
Informed Consent Form, Clinical Study Report, Analytic Code files could be shared
When the data will become available and for how long
2 months after publication
To whom data/document is available
people working in academic institutions or people working in businesses can also apply to receive it
Under which criteria data/document could be used
Intervention purpose
From where data/document is obtainable
Faryal.pt@gmail.com
What processes are involved for a request to access data/document
Full description about the Purpose/Aim of using the documents
Insight about the Disorder and intervention of the research