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CTRI Number  CTRI/2025/05/086104 [Registered on: 01/05/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
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   Exercises and Physiotherapy health education to reduce pain, functional disability, and improve quality of life in low back pain among pregnant women 
Scientific Title of Study   Effectiveness of core stabilization exercises and Physiotherapy health education on pain, functional disability, and quality of life in pregnancy related low back pain: 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  Dr KANCHANA G 
Designation  Master of physiotherapy 
Affiliation  Mother Theresa Post Graduate and Research Institute of Health Sciences 
Address  Obstetrics and Gynecology physiotherapy lab second floor Mother Theresa Post Graduate and Research Institute of Health Sciences Indira Nagar Gorimedu Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8608439834  
Fax    
Email  kanchanaphysio98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Beulah jebakani D 
Designation  Associate professor and HOD Department of Obstetrics and Gynecology Physiotherapy 
Affiliation  Mother Theresa Post Graduate and Research Institute of Health Sciences 
Address  Obstetrics and Gynecology Physiotherapy lab second floor Mother Theresa Post Graduate and Research Institute of Health Sciences Indira Nagar Gorimedu Pondicherry 06

Pondicherry
PONDICHERRY
605006
India 
Phone  8608439834  
Fax    
Email  beulahjebakani@mtpgrihs.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr. KANCHANA G 
Designation  Master of OBG physiotherapy 
Affiliation  Mother Theresa Post Graduate and Research Institute of Health Sciences 
Address  Obstetrics and Gynecology Physiotherapy lab second Floor Mother Theresa Post Graduate and Research Institute of Health Sciences Indira Nagar Gorimedu Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8608439834  
Fax    
Email  kanchanaphysio98@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Medical College and Research Institute Kathirkamam Puducherry 605009 India 
 
Primary Sponsor  
Name  Dr Kanchana G 
Address  MPT OBG 2nd year department of Obstetrics and Gynecology Physiotherapy Mother Therasa Post Graduate and Research Institute of Health Sciences Indiranagar Gorimedu Pondicherry 06 
Type of Sponsor  Other [] 
 
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 Kanchana Govindan  Indira Gandhi Medical College and Research Institute  Antenatal opd Department of Obstetrics and Gynecology kathirkamam pondicherry
Pondicherry
PONDICHERRY 		 08608439834

kanchanaphysio98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (Human Studies) Indira Gandhi Medical College and Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M51||Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Core Stabilization Exercises, Physiotherapy Health Education along with Routine Antenatal Physiotherapy  Core stabilization exercises General Warmup 5 minutes ( Walking, iliopsoas and Para vertebral stretches) Diaphragmatic breathing exercise 10 repetition, deep abdominal exercise 10 repetition, pelvic floor exercise 10 repetition, pelvic bridge 10 repetition, pelvic tilt 10 repetition, bird dog 10 repetition for 30 minutes, cool down exercises 5 minutes. Physiotherapy Health Education consist of back care and relaxation positions for 10 minutes along with Routine Antenatal Physiotherapy such as ankle dorsiflexion and plantarflexion 10 repetition, foot circling 10 repetition, Abdominal drawing in maneuver 10 repetition, breathing exercise 10 repetition for 10 minutes, total duration of the session is 60 minutes 3 sessions per week for 4 weeks. 
Comparator Agent  Routine antenatal physiotherapy  Ankle dorsiflexion and plantar flexion 10 repetition, foot circling10 repetition, Abdominal drawing in maneuver 10 second hold 10 repetition, breathing exercise 10 repetition, total duration of session is 10 minutes 3 sessions per week for 4 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1) Pregnant women referred with c/o of lumbar pain
2) First pregnancy
3) Low back pain score higher than 3/10 on the VAS
4) gestational weeks 20-32
5) Willingness to participate in the study 
 
ExclusionCriteria 
Details  1) History of miscarriage
2) High risk pregnancy
3) Neurological pathology
4) Pharmacological treatments during pregnancy
5) History of lumbar pain prior to pregnancy
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale
 		 Outcome taken from before 1st day of intervention & after 12th day of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
1. Oswestry Disability Index
2. WHOQOL-BREF 		 Outcome taken from before 1st day of intervention & after 12th day of intervention 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   10/06/2025 
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="6"
Days="12" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kanchanaphysio98@gmail.com].

  6. For how long will this data be available start date provided 01-05-2026 and end date provided 02-07-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Effectiveness of Core Stabilization Exercises and Physiotherapy health education on pain, functional disability, and Quality of life in pregnancy related Low back pain: A Randomized Controlled Trial

Low back pain is common during pregnancy and tends to worsen over time, the negative impact of lower back pain, which can negatively impact the quality of life for pregnant women because of the disruption of daily activities. . About half of women continue to have pain 1 year postpartum, and 20% are symptomatic 3 years after delivery. Although paracetamol is considered safe in pregnancy, it does not seem to be very effective on its own for these conditions. Combination of exercise therapy and health education is more effective in treating low back pain during pregnancy than each of these intervention alone. Core stabilization exercises focusing on the PFM and deep abdominal muscles were more effective in improving the pain and disability of patients with low back pain than the usual antenatal exercises. There is moderate to low-quality evidence suggesting that exercise is more effective than standard prenatal care in improving functional ability and decreasing sick leave. Outcome measures- Visual Analogue Scale, Oswestry Disability Index, WHOQOL-BREF . 
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