| CTRI Number |
CTRI/2024/04/065985 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of pelvic stabilization exercises on women post delivery |
|
Scientific Title of Study
|
Effect of Pelvic Stabilization exercises in postnatal women with pelvic girdle pain |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayali Sakpal |
| Designation |
PG Student |
| Affiliation |
Dr.D.Y Patil college of physiotherapy |
| Address |
Dr.D.Y Patil College of Physiotherapy, CBR department, 4th floor Pimpri Sant Tukaram nagar Pimpri, Pune 411018.
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
09106802128 |
| Fax |
|
| Email |
sakpalsayali2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Reema Joshi |
| Designation |
Associate professor |
| Affiliation |
Dr.D.Y Patil college of physiotherapy, Pimpri |
| Address |
Dr.D.Y Patil college of physiotherapy,CBR department, 4 th floor Pimpri. Sant Tukaram nagar Pimpri, Pune 411018.
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9890437630 |
| Fax |
|
| Email |
reema.joshi@dpu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sayali Sakpal |
| Designation |
PG Student |
| Affiliation |
Dr.D.Y Patil college of physiotherapy, Pimpri |
| Address |
Dr.D.Y Patil college of Physiotherapy,CBR department, 4th floor Pimpri Sant Tukaram Nagar, Pimpri 411018
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
09106802128 |
| Fax |
|
| Email |
sakpalsayali2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y Patil college of physiotherapy,CBR department, 4 th floor Pimpri. Sant Tukaram nagar Pimpri, Pune 411018. |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [ ( nil)] |
|
|
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 Reema Joshi |
Dr. D.Y Patil college of physiotherapy |
Dr.D.Y Patil College of Physiotherapy, CBR department, 4th floor Pimpri Sant Tukaram nagar Pimpri, Pune 411018.
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA |
9890437630
reema.joshi@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee of Dr. D.Y patil college of physiotherapy pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
pelvic stabilization exercises |
treatment will be given for 6 weeks,3 sessions per week total of 18 sessions will be given.
Preparation Phase:- Breathing exercises
Week 1- 1. Pelvic tilt (in supine position)
2.Abdominal drawing in (in supine position)
3.Abdominal drawing in with knee to chest (in supine position)
4.Kegel’s exercises in crook lying
Week 2
1.Abdominal drawing in with bridging in supine
2.Partial curl up in supine
3.Abdominal drawing in with heel slides
4.Kegel’s exercises in crook lying
Week 3
1.supine dead bug
2.Abdominal drawing in with single-leg butt lift
( bilateral)
3.Prone on elbow
4.Kegel’s exercises in crook lying
Week 4
1.Curl up
2.Quadruped opposite arm and leg
3. Thoracic elevation
4.Kegel’s exercises in kneeling
Week 5
1.Superman position
2.Plank in prone
3.Side plank on elbow ( bilateral)
4.Kegel’s exercises in kneeling position
Week 6
1.Side plank with hip abduction ( bilateral)
2.Seated Russian twist
3.Kegel’s exercises in sitting
Termination phase :- Shavasana
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Females willing to participate
Females between age 19 – 40 years old
Postpartum women from 6 weeks to 6 months
Pain located distally/laterally of L5-S1, over the buttocks and/or the pubic bone, verified by 2 positive pain provocation tests and a positive active straight leg raise (ASLR).
|
|
| ExclusionCriteria |
| Details |
Previous fracture, surgery or malignant disease in the back, pelvis or hips.
Any systemic disease or obstetrical complication that contraindicates treatment or tests
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. pelvic girdle questionnaire
2. numerical pain rating scale |
At the beginning and at the end of the study ( 6
weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pressure biofeedback |
At the beginning & the end of the study ( 6
weeks) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
10/01/2025 |
| Date of First Enrollment (Global) |
01/05/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Thi This study is a Single arm Quasi-experimental study, studying the effect of pelvic stabilization exercises in postnatal women with pelvic girdle pain for 6 weeks 3 days per week in 40 patients with pelvic girdle pain. This study will be conducted in Dr. DY Patil College of Physiotherapy. The primary outcome measures are the Numerical pain rating scale (NPRS), and pelvic girdle questionnaire (PGQ) and the secondary outcome measure is pressure biofeedback. all will be measured at the beginning and post-treatment. Later analysis will be done |