| CTRI Number |
CTRI/2024/08/071809 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
01/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Manual Therapy Techniques in Sacroiliac Joint Dysfunction A Randomised Controlled Trial |
|
Scientific Title of Study
|
Effectiveness of Manual Therapy Techniques for Sacroiliac Joint Dysfunction A Randomized Controlled 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 |
Asha |
| Designation |
MPT Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Room No.07, Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9050200544 |
| Fax |
|
| Email |
sharmaa31740@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Malik |
| Designation |
assistant professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Room No.102, Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar Haryana
Hisar
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
manojmalikpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Malik |
| Designation |
assistant professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology Hisar |
| Address |
Room no.102, Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar Haryana
Hisar
Hisar
HARYANA
125001
India |
| Phone |
9896221262 |
| Fax |
|
| Email |
manojmalikpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Guru Jambheshwar University of Science and Technology,
Hisar,Haryana 125001 |
|
|
Primary Sponsor
|
| Name |
Asha |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAsha PT |
Guru Jambheshwar University of Science and Technology |
Room no.07
Department of
Physiotherapy Guru
Jambheshwar
University of Science
and Technology Hisar
Hisar
HARYANA |
9050200544
sharmaa31740@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe e,Department of Physiotherapy GJUST Hisar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S332||Dislocation of sacroiliac and sacrococcygeal joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Spinal stabilization exercise
myofascial release
muscle energy technique |
Group A Stabilization exercise Group B Myofascial release with Stabilization exercise GROUP C Muscle energy technique with Stabilization exercise for 5 days in week for 3 weeks |
| Comparator Agent |
spinal stabilization exercise
|
patients in this group will undergo regular spinal stabilization exercises for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Positive Faber test
Positive gaensalen test
|
|
| ExclusionCriteria |
| Details |
• Lumbar PIVD
Radicular pain
Piriformis syndrome
Ankylosing spondylitis
TB of spine
Metastasis of spinal tumor
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Oswestry Disability Index
Electromyography |
At baseline and after 3 weeks of intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/08/2024 |
| 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="3"
Days="15" |
|
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
|
Low back pain is one of the most common global health problems and creates a substantial burden on society. An estimated 70 to 85 % of the western population will develop back pain at least once during their life time. Sacroiliac joint pain is one of the most common causes of low back pain, accounting for 15 to 30 % of all cases. Although Sacroiliac joint dysfunction account for a large portion of chronic low back pain prevalence it is often overlooked or under diagnosed.There are many studies have been conducted on patient of sacroiliac joint dysfunction.There is evidence on effectiveness of the combination of various manual therepies on sacroiliac joint dysfunction.The purpose of this study to identify and compare the effectiveness of various manual therapy like stabilization exercise,myofacial release and muscle energy techniques. |