| CTRI Number |
CTRI/2024/06/069083 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effects of Mulligan’s movement with mobilization on SIJ Dysfunction |
|
Scientific Title of Study
|
Effects of Mulligan’s movement with mobilization in anterior and posterior innominate Iliosacral Dysfunction |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikas Singh |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, Rohtak |
| Address |
College of Physiotherapy, room no.4, E-block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9899508171 |
| Fax |
|
| Email |
vikassinghrathore98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meetu Nagpal |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, Rohtak |
| Address |
College of Physiotherapy, room no.4, E-block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416403155 |
| Fax |
|
| Email |
meetunagpalpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meetu Nagpal |
| Designation |
Assistant Professor |
| Affiliation |
College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, Rohtak |
| Address |
College of Physiotherapy, room no.4, E-block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416403155 |
| Fax |
|
| Email |
meetunagpalpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, room no. 4, E- block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Vikas Singh |
| Address |
College of Physiotherapy, room no. 4, E- block, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
| Type of Sponsor |
Other [Self ] |
|
|
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 Pradyumna Krishna M |
Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak |
Ch. Ranbir Singh OPD, Department of Orthopaedic, Room No. 29, Pt. B. D. Sharma, Rohtak
Rohtak
HARYANA |
7988153640
Pradyumnakm2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M249||Joint derangement, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mulligan’s Movement with Moblization in anterior and posterior innominate iliosacral dysfunction |
The patient will be asked to do spinal extensions in lying provided there is no pain for 10 repetitions per set and up to three sets. Secondly: In case the patient comes with an anterior pelvic tilt, the anterior innominate method will be performed on the affected side. The patient will lie in a prone position and the therapist will fixate the sacrum with the border of one hand and will place the fingers of his other hand under the opposite ASIS. The therapist will pull the ilium up on the sacrum and hold this position while the patient will do 10 times extension per set and up to three sets, provided these are pain-free. A total of 6 sessions will be provided on alternate days for 2 weeks. Post treatment readings for all outcome variables will be taken on Day 15th. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Male and Female
2 Age 20-50 years
3 Unilateral iliosacral joint dysfunction confirmed with at least 3 out of 5 tests
positive (Distraction test, Compression test, Thigh thrust test, Gaenslen’s test,
Sacral thrust test).
4 Anterior or Posterior innominate dysfunction will be further confirmed with
Gillet’s test, Standing flexion test, Sitting flexion test and long Sitting test. |
|
| ExclusionCriteria |
| Details |
1 History of recent trauma
2 Infection
3 Osteoporosis
4 Structural deformity
5 Inflammatory disorder
6 Cauda equina syndrome
7 Pregnancy
8 Diagnosed abnormality on radiological examination
9 Physician advised inactivity
10 Inability to understand or follow commands |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Functional Disability
2 Pain
3 Lumbar Mobility |
Day1 then on Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mulligan’s movement with mobilization |
A total of 6 sessions (on alternate days) will be given to the patient within 2 weeks of time span |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/06/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Pelvic pain and referred pain in the proximal hip joint area are commonly linked with Sacroiliac joint dysfunction (SIJD). The pain of the sacroiliac joint usually arises below L5, S1 and it is associated with groin pain which is a nociceptive source of pain surrounding lumbosacral structures.2 There are no provoking or relieving movements or positions that are unique or especially common to SIJ pain. SIJD typically results in inflammation of the sacroiliac joint and can be debilitating. It is a condition of malalignment or altered mechanics theories simply caused by the augmented or uncharacteristic motion of the ilium around the sacrum known as iliosacral dysfunction or augmented or uncharacteristic motion of the sacrum around the ilium (nutation and counter nutation) known as a sacroiliac disorder, both of these disorders may irritate sacroiliac joint structures (joint capsule, its ligaments and pain receptors located in the joint) resulting in sacroiliac joint dysfunction. By correcting the innominate anterior and posterior rotation with respect to the sacrum, the Mulligan’s MWM method, when used on SIJ, makes load transfer successful. Movement with mobilization of sacroiliac joint restores sacroiliac mobility by using the hip’s or lumbar’s end range of motion. In this manual technique, the physiotherapist applies sustained glide at a particular joint while the patient actively performs the physiological movement. Mobilization of the sacroiliac joint prevents adhesion formation by repairing and improving the flexibility and tensile strength of tissues and helps to increase the healing process by facilitating fluid flow to the tissues, also promoting the elongation of shortened tissues. Mobilization of joints also enhances vascular flow and thus reduces pain by removing free radicals. The purpose of the study is to investigate the effects of movement with mobilization on anterior and posterior innominate iliosacral dysfunction. This study has no side effects or risks involved to the best of my knowledge. |