| CTRI Number |
CTRI/2024/08/072346 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Gluteus Maximus activation technique v/s Illiopsoas Pnf stretching technique in patients with Sacroilliac joint Dysfunction. |
|
Scientific Title of Study
|
Gluteus Maximus Activation technique v/s Illiopsoas Pnf stretching technique on pelvic tilt angle, pain, range and function in subjects with Sacroilliac joint Dysfunction :a Randomised Clinical 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 |
Simran Aga |
| Designation |
Post Graduate Student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy,OPD no 39,room.no 18,Nehru Nagar Belgavi Karnataka
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy,OPD no 39,room.no 18,Nehru Nagar Belgavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9022654296 |
| Fax |
|
| Email |
simranaga86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy,OPD no 39,room.no 18 Nehru Nagar ,Belagavi Karnataka
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy,OPD no 39,room.no 18,Nehru Nagar Belgavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Vijay Kage |
| Designation |
Professor |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy,OPD no 39,room.no 18,Nehru Nagar ,Belgavi Karnataka
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy,OPD no 39,room.no 18,Nehru Nagar Belagavi Karnataka
KARNATAKA
590010
India |
| Phone |
9845271899 |
| Fax |
|
| Email |
vijaykage@yahoo.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research.
Nehru-nagar,Belgavi-Karnataka |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy,OPD no 39,room.no 18,Nehru Nagar Belgavi-Karnataka 590010 |
| 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 |
| Vijay Kage |
KLEs Dr. Prabhakar Kore Hospital, Belgavi - Karnataka |
KAHER Institute of Physiotherapy, Department of Orthopaedic Physiotherapy,OPD no 39,room.no 18,Nehru Nagar Belgavi Karnataka
Belgaum
KARNATAKA |
9845271899
vijaykage@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gluteus Maximus Activation technique + Conventional treatment. |
Gluteus Maximus Activation technique + Conventional treatment.Each subject will be given three sessons per week for two weeks. |
| Intervention |
Illiopsoas Pnf stretching technique +conventonal treatment |
Illiopsoas Pnf stretching technique +conventonal treatment.
Each subject will be given three sessons per week for two weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
subject:
1.All gender between 18-50 years of age.
2 with chronic sacroiliac joint dysfunction for more than 3 months.
3.positive findings of Posterior pelvic pain provocation (P4) test.
4.Clinically diagnosed case of SI Joint Dysfunction.
5.willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Subjects
1. Undergone recent surgeries.
2. Lower limb fractures
3. History of trauma.
4. Pregnant women
5. Any congenital posture problem
6. Psychological problem
7. Cancer
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1] pelvic tilt angle using pelvic inclinometer.
2] pain using Numerical Pain Rating Scale
3] hip range using Universal Goniometer.
4] hip extensibility using Thomas Test
5]function using Modified Oswestry Disability Index
|
pre- baseline
post -2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/08/2024 |
| Date of Study Completion (India) |
21/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/01/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Aim:To determine and compare the effect of Gluteus Maximus Activation Technique with Iliopsoas PNF Stretching in subjects with Sacroiliac joint Dysfunction.Objective:To determine and compare the effect of Gluteus Maximus Activation Technique with Iliopsoas PNF stretching in terms of pelvic tilt angle,pain , range and function in subjects with Sacroiliac joint Dysfunction.Null hypothesis: There will be no change in the effect Gluteus Maximus Activation Technique with Iliopsoas PNF Stretching on pelvic tilt angle, pain, range and function in subjects with Sacroiliac joint Dysfunction.Alternative hypothesis:There will be change in the effect Gluteus Maximus Activation Technique with Iliopsoas PNF Stretching on pelvic tilt angle ,pain, range and function in subjects with Sacroiliac joint Dysfunction.Inclusion Criteria: All gender between 18-50 years of age.with chronic sacroiliac joint dysfunction for more than 3 months.,.,positive findings of Posterior pelvic pain provocation (P4) test.Clinically diagnosed case of SI Joint Dysfunction.and those willing to participate in the stud,Exclusion criteria:Subjects undergone recent surgeries.lLower limb fractures.,history of trauma.,pregnant women ,any congenital posture problem.,psychological problem. cancer. A written informed consent will be obtained from the subjects in their own language and those consenting will be included in the intervention.Brief demographic data will be obtained from each prior to the assessment.Subjects will be divided into two groups: GROUP A(Gluteus Maximus Activation and GROUP B (Iliopsoas PNF Stretching.Each subject will be treated for 6 sessions, 3 session/week for 2 weeks.An individual approach will be given by a qualified physiotherapist in the physiotherapy OPD. Conventional Treatment –Subject position: Subject will be in prone lying position.In both the groups Hydrocollator pack will be applied for a duration of 10 minutes prior to the intervention.5Interferential current will be applied for a duration of 15 minutes by placing the two electrodes over the PSIS and other two over the gluteus muscle in a quadripolar fashion with a beat frequency of 100 Hz . |