| CTRI Number |
CTRI/2025/08/093085 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study Comparing Four Types of Physical Therapy to Help with Pain, Movement, and Balance in People with Lower Back and Pelvic Joint Problems |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Mulligan Mobilization, Maitland Mobilization, High Velocity Thrust, and Muscle Energy Technique on Disability, Pain and Displacement of Center of Gravity in Subjects with Sacroiliac Dysfunction - A Four Arm Parallel Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Chitale |
| Designation |
PhD Scholar |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Musculoskeletal Physiotherapy, Ground floor Room no 2, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education And Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9730508403 |
| Fax |
|
| Email |
nchitale123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lajwanti Lalwani |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, Ground floor, Room No 5, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8605234269 |
| Fax |
|
| Email |
lajwanti.rnpc@dmiher.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Neha Chitale |
| Designation |
PhD Scholar |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Musculoskeletal Physiotherapy, Ground floor Room no 2, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education And Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9730508403 |
| Fax |
|
| Email |
nchitale123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra, India -442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neha Vinay Chitale |
Acharya Vinoba Bhave Rural Hospital |
Musculoskeletal Physiotherapy OPD, Department of
Musculoskeletal
Physiotherapy, Ravi
Nair Physiotherapy
College, Datta Meghe
Institute of Higher Education and Research, Sawangi,
Meghe, Wardha,
Wardha
MAHARASHTRA |
9730508403
nchitale123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee DMIHER DU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High Velocity Thrust |
HVT for Ilium- Anteriorly
The subject will be asked to be in supine lying and will be instructed to hold opposite shoulder. The therapist stands on the opposite side. Both the lower limbs are crossed with involved side above the normal side. Therapist then passively flexes the spine and keeps one hand on ASIS. The upper trunk is rotated and Thrust in applied
HVT for Ilium- Posteriorly
Subject will be positioned in side lying. The therapist grabs the PSIS with one hand and uses other hand to hold the anterior thigh. The therapist aill stand facing the patient and rotate anteriorly and thrust is given.
HVTM for up slip ilium correction
The patient is positioned in a supine. The therapist stands at the foot end of the mobilization table. The therapist grasps the tibia just above the ankle and pulls it downwards and thrust is given.
HVTM for down slip ilium correction
The therapist will stand on the affected side of the patient. The hip is flexed and abducted. The therapist will support one knee and heel of the patient. Thrust will be applied in cephalic direction. |
| Comparator Agent |
Maitland’s Mobilization |
Upper pelvic tilt backward when the patient is on the other side. 90-degree flexion of the hip and knee. The therapist stands in front of the patient and places his right hands heel over the posterior surface of the patients left Ischial tuberosity. He then places his left hand over the patients ASIS and pushes the patients Ischial tuberosity forward, causing a rotary strain on the S.I. joint. The therapists fingers and forearm point over the patients hip towards the therapists face. 5. The patient retains the same posture as the therapist applies a forward tilt of the upper pelvis, pressing the heel of his left hand against the posterolateral edge of the iliac crest. The therapists fingers point upward, encircling the Ilium and cupping the palm of his right hand over the left ischial tuberosity. The patients pelvis is covered by fingers that move backward, applying alternating rotational strain to the S.I. joint, while the patients upper pelvis is tilted forward. 6. With the patient lying supine, the therapist places one hand under the side of the ASIS that needs to move cephalic and the other hand over the opposite side of the ASIS that needs to move caudally. The therapist uses her pectoral muscle to concurrently move the ASIS in the opposite caudad and cephalad directions, moving to the symphysis pubis via the ASISs. |
| Intervention |
Mulligan’s Mobilization |
When using the posterior innominate approach, the patient will be lying prone, and the therapist will place his hands thenar eminence on the opposite iliums somewhat projecting posterior border and push it away from him. If the patient is in no pain, they will be requested to perform extension while lying down for up to three sets of ten repetitions each. Second: The patient will be in a prone laying position as the therapist applies the anterior innominate approach. He will fixate the sacrum with the border of one hand while placing the fingers of the other hand beneath the opposite ASIS. The patient will perform ten extensions per set as the therapist pulls the ilium up on the sacrum and holds it there. |
| Comparator Agent |
Muscle Energy Technique |
The MET technique for correction of anterior dysfunction of the sacroiliac joint will be performed by placing the individual in a lateral position on the opposite side to that of the dysfunction. The examiner will block the leg, while the unaffected leg remains extended on the stretcher. The leg will be placed in hip flexion until the first point of tension that prevents the posterior rotation of the ilium will be found. While this technique is being used, the patient will be asked to push his leg into hip extension while the examiner holds it and prevents movement. Four contractions will be performed, resisted by the therapist, and held for 7–10 s. The individual will then be asked to relax the leg and the examiner then continue to perform the hip flexion until a new point of tension is found. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to sign informed consent
2. Patients diagnosed with sacroiliac dysfunction.
3. Both males and females between the age of 18 - 35 years.
4. Patients on which Gaenselin’s and Gillet’s test is positive.
5. Patients with non-specific low back pain, and stiff back region for at least 3 months.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a recent history of surgery on the back region.
2. Post-traumatic back pain and stiffness.
3. Patients with Lumbar radiculopathy
4. Patients with a previous history of fracture at the lower limb or back region.
5. Patients with pathology related to the spine.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. VISUAL ANALOGUE SCALE (VAS)
2.Modified Oswestry Disability Index
3.Center of Gravity (COG) |
All outcomes will be assessed Pre-intervention
on 1st day, post
intervention on 21st day, and post
intervention on 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sacroiliac
dysfunction is a condition in which the movement between the sacrum and iliac
bones is affected, leading to pain and dysfunction. The problem is often masked
by low back pain. Specific treatment approaches for sacroiliac dysfunction
include mobilization, exercise prescription, and electrotherapeutic management.
This is a four-arm parallel trial conducted to establish the rank order between
four physiotherapy interventions given for sacroiliac dysfunction. Outcome
measures to assess will be the pain rating scale, disability index, and Center
of gravity. based on the outcomes. To determine the
significance of the difference between the four groups, the student t" test will be employed. We will compare the parameters among the
three groups using a paired "t" test. Repeated measures of ANOVA will
be employed to determine the significance of changes between pre- and
post-treatment. Rank order will be established post study. |