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CTRI Number  CTRI/2024/01/061232 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On: 08/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of 4 weeks of egoscue exercises with conventional physiotherapy on pain,disability abd lumbar hyperlordosis in post natal females with pelvic girdle pain. 
Scientific Title of Study   Effect of 4 weeks egoscue exercises with conventional physiotherapy on pain,disability and lumbar hyperlordosis in post natal females with pelvic girdle pain. a randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shital Babruwan Ghule 
Designation  Phd Scholar  
Affiliation  DVVPFs College of physiotherapy, Ahmadnagar 
Address  DVVPFs college of physiotherapy, Ahmednagar, Maharashtra, India 414111

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  9689568795  
Fax    
Email  shitalphad900@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhijit Divate 
Designation  Professor and HOD of the department of cardiovascular respiratory department cardio 
Affiliation  DVVPFs College of physiotherapy, Ahmadnagar 
Address  DVVPFs college of physiotherapy, Ahmednagar, Maharashtra, India 414111

Ahmadnagar
MAHARASHTRA
414111
India 
Phone  8554990222  
Fax    
Email  abhijitdiwate@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shital Babruwan Ghule 
Designation  Phd Scholar  
Affiliation  DVVPFs College of physiotherapy, Ahmadnagar 
Address  DVVPFs college of physiotherapy, Ahmednagar, Maharashtra, India 414111


MAHARASHTRA
414111
India 
Phone  9689568795  
Fax    
Email  shitalphad900@gmail.com  
 
Source of Monetary or Material Support  
DVVPFs college of physiotherapy, Opp. Govt. milk dairy, MIDC Ahmednagar, Maharashtra, India 414111  
 
Primary Sponsor  
Name  DVVPFs College of physiotherapy 
Address  DVVPFs college of physiotherapy, Ahmednagar, Maharashtra, India 414111  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 
Dr Shital Ghule  DVVPFs College Of physiotherapy, Ahmadnagar  Dept. of obstetrics DVVPFS Medical college ahmednagar
Ahmadnagar
MAHARASHTRA 		 9689568795

shitalphad900@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional exercises with Stretching  conventional exercises incldes i) Crook lying ii) Supine with leg raise iii) Crook lying with leg down iv) Prone lying v) Plank position vi) Supine lying with one knee flexed vii) Sitting on bobath viii) Sitting on chair ix) Cat camel exercise x) Heel Slides xi) Quadruped bird dog intervention duration 4weeks dosage 5 times in a week 
Intervention  Egoscue Exercises  Egoscue exercise protocol includes Following group of exercises a)Static back, b)Static back with abdominal contraction, c)Abductor press, d)Pelvic tilt, e)Static extension, f)Elbow curls, g)Air bench, h)Static wall, i)Overhead extension, j) Spinal twist, k)Supine groin progression Intervention duration 4weeks dosage 5 times in a week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  38.00 Year(s)
Gender  Female 
Details  - Primiparous women between the ages 18 and 38 years.
- Subjects will be eligible for the study after suture removal within 12 weeks following the caesarean section delivery.
- Anterior pelvic tilting more than 13- 15 degree
- Pain experienced distal to L5 and pain in the pelvic girdle region between the posterior iliac crest and the gluteal fold, with or without radiation in the posterior thigh and calf, and with and without pain in the symphysis.
- Pain onset during pregnancy or within 12 weeks from delivery.
- Subjects willing to participate
- Subject should have fulfillment of the diagnostic criteria based on the following tests: ASLR test, P4 test and symphysis pubis palpation test. (Score of at least 2)
- Positive pelvic pain provocation test must reproduce a familiar pain in the woman, with regard to location and quality.
 
 
ExclusionCriteria 
Details  Subjects not willing or unable to provide informed consent.
- Women with a history of systemic locomotor system disease.
- Previous surgery of the spine, pelvis, or femur, back pain indicating radiculopathy.
- Subjects with other pain conditions, or contraindications to treatment were excluded
- Generalized osteoporosis.
- Suture infection or unhealed
- Gynecological problems where the woman was advised complete bed rest.
- Treatment with stabilizing exercises or general exercises that focused on the lumbopelvic system in the 3 months prior to this
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Degree of lumbar lordosis using index of lumbar lordosis 2. Anterior pelvic tilt using pelvic inclinometer3. Oswestry disability Index:   Baseline
after 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
New York Posture Rating Scale (NYPRS)
Functional active straight leg raise test (ASLR test)  		 Baseline
after 4 weeks  
 
Target Sample Size   Total Sample Size="115"
Sample Size from India="115" 
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)   16/01/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
The study is to identify the effectiveness of Egoscue exercises over Conventional physiotherapy along with stretching on various outcome parameters such as pain, disability, and lumbar lordosis in postnatal females with pelvic girdle pain all included patients will be divided into two groups. group A will receive egoscue exercises protocol with conventional physiotherapy group B will receive conventional physiotherapy along with both groups will receive common stretching exercises. ODI, anterior pelvic tilt, and lumbar lordosis percentage are primary outcome measures with the new york postural rating scale and an active straight leg raise test will be assessed at baseline and after 4 weeks of intervention. Anterior pelvic tilting with the help of a pelvic inclinometer, the percentage of lumbar lordosis will be measured by flexi curve Oswestry disability index, New York posture assessment chart, and ASLR will be measured. In both experimental and conventional group treatment protocols total duration of the session would be 35 to 40 minutes.   Data will be collected by using a structure proforma. Data will be entered in an MS excel sheet and will be analyzed by using SPSS 24.0 version IBM USA. Qualitative data will be expressed in terms of proportions Quantitative data will be expressed in terms of Mean and Standard deviation. Association between two qualitative variables will be seen by using Chi-square/ Fischer’s exact test.


 
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