| CTRI Number |
CTRI/2023/08/056798 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
29/08/2023 |
| 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
|
Effect of different physiotherapy treatment on low back pain after delivery. |
|
Scientific Title of Study
|
Effect of various therapeutic interventions on sacro-iliac joint dysfunction in post-partum females. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pinky |
| Designation |
Research Scholar |
| Affiliation |
Guru Jambheshwar University of Science and Technology, hisar |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9996560074 |
| Fax |
|
| Email |
pinkyjangra1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaspreet Kaur |
| Designation |
Associate Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaspreet Kaur |
| Designation |
Associate Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology, Hisar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pinky |
Guru Jambheshwar University of Science and Technology |
Room no.1, OPD Department of Physiotherapy
Hisar
HARYANA |
9996560074
pinkyjangra1992@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GJU Science and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sacroiliac Joint Dysfunction in Post-Partum Females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Normal Range of Motion Exercises for 6 weeks (3 sessions per week) |
| Intervention |
Group A |
Group A will receive Mobilisation for 6 weeks (3 sessions per week) |
| Intervention |
Group B |
Group B will receive MET for 6 weeks (3 sessions per week) |
| Intervention |
Group c |
Group C will receive Core Stabilization Exercises for 6 weeks (3 sessions per week) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with SIJD.
2. Primiparous and Multiparous women.
|
|
| ExclusionCriteria |
| Details |
1. Any spine and hip surgery less than 1 year.
2. Pregnancy
3. Osteoporosis or bone fracture
4. Any corticosteroids or anesthetics used for less than 6 months
5. Sacroileitis or sacroiliac infection.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Sacral Angle
2. Photogrammetry
3. Gait ( cadence, stride length, step length, walking velocity)
4. Oswestry Disability Index
5. EMG
|
The participants will be assessed at baseline (Pre intervention data), & after 6 weeks (post-intervention) and after one month (follow-up) . There will be 18 session in each group (three session per week for 6 weeks). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
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)
|
30/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/08/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Sacroiliac joint dysfunction is a very common problem and it is affecting the quality of daily living and has become a serious problem among the post partum females. It can alter the leg length, spinal alignment and affect the quality of daily living. To our knowledge no work has been done to find out the efficacy of therapies focused on SIJD in post partum females. This study will try to provide a effective intervention of SIJD in post partum females. A Randomized controlled trial will be conducted. Initially participants will be screened on the basis of selection criteria. Then they will be randomized into four groups; Mobilizaton group (A), Muscle Energy Technique (B), Core Stabilization exercise group (C), and Control group (D). The participants will be assessed at baseline (Pre intervention data), and after 6 weeks (post-intervention) and after one month (follow-up) . There will be 18 session in each group (three session per week for 6 weeks). The main objective of the study is to compare the effectiveness of Mobilization, Muscle Energy Technique and Core Stabilisation on SIJD in post partum females.
|