| CTRI Number |
CTRI/2025/05/086104 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| 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
|
|
|
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
Modification(s)
|
| 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
|
|
|
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)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2025 |
| Date of Study Completion (India) |
12/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Applied |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pregnancy-related low back pain is a common musculoskeletal condition affecting more than half of pregnant women. It worsens during the second and third trimesters, leading to significant functional limitations and reduced quality of life. Because Pharmacological treatment options are limited during pregnancy, there is a growing emphasis on safe, conservative interventions to relieve pain and maternal wellbeing. Objective: To evaluate the effectiveness of Core stabilization exercises and physiotherapy health education on pain, functional disability and quality of life in pregnancy related low back pain. Materials and Methods: A randomized controlled trial was conducted with 36 pregnant women with lumbar pain, allocated into an experimental group (n = 18) and a control group (n = 18). The experimental group received core stabilization exercises along with physiotherapy health education, while the control group received routine antenatal care. The primary outcome was pain intensity assessed by Visual Analogue Scale. Secondary outcomes include functional disability assessed using Oswestry Disability Index and quality of life using WHOQOL-BREF were assessed at baseline and after 4 weeks. Results: Data were analysed using repeated measures ANOVA shows a significant reduction in pain (VAS p < 0.001) and functional disability (ODI: p < 0.001) was observed in the intervention group compared to the control group. Quality of life significantly improved across all domains in the intervention group: physical (p < 0.001), psychological (p < 0.001), social (p = 0.008), environmental (p < 0.001), and general (p < 0.001), with corresponding significant group effects (p < 0.05). Conclusion: The results proves that the Core stabilization exercises combined with physiotherapy health education are effective in reducing pain, disability and quality of life among pregnant women with low back pain . |