| CTRI Number |
CTRI/2025/07/089941 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding the Causes of Foot Pain in Women During the Last Months of Pregnancy |
|
Scientific Title of Study
|
Factors associated with foot pain in pregnant women during third trimester |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashveya Joylin Dias |
| Designation |
MPT student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no 215 Department of Physiotherapy Second floor Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6360290617 |
| Fax |
|
| Email |
ashveya.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no 211 Department of Physiotherapy Second floor Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no 211 Department of Physiotherapy Second floor Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room no. 215 Department of Physiotherapy Second floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar Manipal - 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal - 576104 |
| 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 |
| Dr Ashveya Joylin Dias |
Manipal Academy of Higher Education |
Women and Children Block Ground Floor Obstetrics and Gynecology OPD Kasturba Hospital Manipal - 576104
Udupi
KARNATAKA |
6360290617
ashveya.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O288||Other abnormal findings on antenatal screening of mother, (2) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
- Pregnant women with unilateral/ bilateral foot pain
- NPRS more than 3 present at least for 1 week
- Primigravida/ Multigravida
- Period of gestation between 28-40 weeks |
|
| ExclusionCriteria |
| Details |
- Foot pain prior to pregnancy with conditions such as plantar fasciitis, flat feet, heel spurs, bunions, hammer toes, metatarsalgia
- Foot pain before third trimester who has been receiving Physiotherapy intervention or who is using medial arch support
- Any neuromuscular conditions affecting the mobility
- High risk pregnancy such as preeclampsia, intellectual or psychiatric impairment, systemic diseases or recent spinal fracture, trauma or surgery
- Pregnant women who have been advised restricted bed activity by the clinician |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Foot pain, Foot posture, Plantar pressures, Musculoskeletal issues, Physical activity level |
Single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
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)
|
15/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This study will help in gaining knowledge about different factors that would affect foot pain in pregnant Indian women in their last trimester. The factors that we are looking into are age, BMI, gestational weight gain, plantar pressures, foot posture, pedal edema, physical activity, footwear choices and related issues like back and lower limb pain and how these affect the pregnant women. There are a few studies which look into how these cultural factors effect foot pain. Understanding the association would help in better evaluation and management of the symptom. Pregnant women aged between 18 to 40 years with unilateral or bilateral foot pain who have a pain score of more than 3 in NPRS for at least a week who are primigravida/ multigravida in their third trimester will be included in the study. The women visiting the OPD will be screened for the inclusion and exclusion criteria and will be selected accordingly. A written informed consent will be obtained after explaining the study. Demographic details about the participants will be recorded. Data will be collected on the data collection form. The foot pain scores will be recorded using the Numerical Pain Rating scale. The foot posture will be assessed employing the Foot posture Index. The physical activity will be assessed using GPAQ. The participants shall be administered with the Manipal Musculoskeletal Dysfunction screening Tool for pregnant women. They will be requested to stand on the Gait checker for 30 seconds and their static plantar pressures will be recorded from the system. The data will be entered and then analyzed. |