| CTRI Number |
CTRI/2025/07/091054 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Exploring the musculoskeletal and biomechanical changes in pregnancy. |
|
Scientific Title of Study
|
Exploring the musculoskeletal pain and biomechanical changes during
pregnancy: A cross-sectional study.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garima Singh |
| Designation |
Post graduation Student in Physiotherapy |
| Affiliation |
Guru Nanak Dev University, Amritsar |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India.
Amritsar
PUNJAB
143001
India |
| Phone |
8937978136 |
| Fax |
|
| Email |
GARRIIMASINGH@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharnpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University, Amritsar |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India.
Amritsar
PUNJAB
143001
India |
| Phone |
9877781036 |
| Fax |
|
| Email |
sharnpreet.pht@gndu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharnpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University, Amritsar |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India.
PUNJAB
143001
India |
| Phone |
9877781036 |
| Fax |
|
| Email |
sharnpreet.pht@gndu.ac.in |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Dev Hospital, Majitha Road, Medical Enclave, Amritsar, Punjab,India, Pincode- 143001 |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Dev University Amritsar |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India, Pincode- 143001 |
| Type of Sponsor |
Other [Government education Institute/ University] |
|
|
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 |
| Garima Singh |
Guru Nanak Dev Hospital, Majitha Road, Medical Enclave, Amritsar, Punjab, India, Pincode- 143001 |
Room No- 1, Unit-1, Gynecology OPD.
Amritsar
PUNJAB |
08937978136
GARRIIMASINGH@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Guru Nanak Dev University,Amritsar-143005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Pregnant Females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women between the ages of 18 and 45 years.
Pregnant women of all three trimesters. |
|
| ExclusionCriteria |
| Details |
Presence of any MSD before the onset of pregnancy.
Presence of any musculoskeletal deformities of the joints, limbs, or spine prior to pregnancy.
History of traumatic injury to the musculoskeletal system 1 year before the pregnancy.
History of any orthopaedic surgery (Hip surgery, Knee surgery, fracture surgery) and History
of any neurological problem.
Refusal to give informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To investigate musculoskeletal pain, biomechanical changes, and discomfort during the first three
trimesters of pregnancy.
A correlation between musculoskeletal pain and biomechanical factors throughout the first
three trimesters of pregnancy. To evaluate the impact of musculoskeletal pain and biomechanical alterations affect everyday
living activities, fall phobia, exercise, and balance. |
Baseline data |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/07/2025 |
| 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="0"
Months="3"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
I am working on the pregnant women of the three trimesters. As in these three trimesters of pregnancy, musculoskeletal discomfort and pain with biomechanical deviations are very common. So here I am investigating musculoskeletal pain and discomfort. I will also observe the biomechanical changes. And then I will find out the prevalence and correlation among them with physical activity, balance, and fear of falling. |