| CTRI Number |
CTRI/2024/01/062103 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To calculate the occurrence of pain and swelling in wrist and hand among pregnant females during their last three months visiting pregnancy checkup clinic. |
|
Scientific Title of Study
|
Assessment of prevalence of Carpal Tunnel Syndrome among third
trimester pregnant women visiting Antenatal Care Clinic of
Obstetrics and Gynaecology Outpatient Department at government
tertiary care hospital-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 |
Dr Chhaya V Verma |
| Designation |
Professor and Head of Department |
| Affiliation |
Topiwala National Medical College and B.Y.L. Nair Charitable Hospital |
| Address |
OPD 24, ground floor, Physiotherapy School and Centre,Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223027515 |
| Fax |
|
| Email |
cvverma100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya V Verma |
| Designation |
Professor and Head of Department |
| Affiliation |
Topiwala National Medical College and B.Y.L. Nair Charitable Hospital |
| Address |
OPD 24, ground floor,
Physiotherapy School and Centre,Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road
MAHARASHTRA
400008
India |
| Phone |
02223027515 |
| Fax |
|
| Email |
cvverma100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhaya V Verma |
| Designation |
Professor and Head of Department |
| Affiliation |
Topiwala National Medical College and B.Y.L. Nair Charitable Hospital |
| Address |
OPD 24, ground floor,
Physiotherapy School and Centre,Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road
MAHARASHTRA
400008
India |
| Phone |
02223027515 |
| Fax |
|
| Email |
cvverma100@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physiotherapy School and Centre, Topiwala National Medical College & B.Y.L. Nair Charitable Hospital, Dr. A. L. Nair Road, Mumbai. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Chhaya V Verma |
Topiwala National Medical College & B.Y.L. Nair Charitable Hospital. |
Physiotherapy School and Centre, Patel Compound, N Building, Ground Floor, Behind T.N.M.C Canteen, Dr. A.L. Nair Road, Mumbai- 400008
Mumbai
MAHARASHTRA |
9082797203
cvverma100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women in third trimester having a USG scan report |
|
| ExclusionCriteria |
| Details |
1. Known case of Diabetes Mellitus, Blood pressure (hypotension, hypertension),
Thyroid disorder (hypothyroidism), cardiac disease, renal disease before
conception
2. Known case of Cervical Spondylosis
3. Fracture of cervical vertebrae or any bone of upper extremity
4. Prior history of CTS confirmed by electrophysiological evidence
5. Known case of any previous Rheumatoid conditions
6. Trauma to hand or wrist |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Boston Carpal Tunnel
Syndrome
Questionnaire (BCTQ) |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Wrist Ratio Index
2.Wrist-Palm Ratio [WPR]
3.Phalen’s Test
4.2 Point Discrimination test
5.Body mass index (BMI) |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
Final Enrollment numbers achieved (Total)= "246"
Final Enrollment numbers achieved (India)="246" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2024 |
| Date of Study Completion (India) |
18/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
18/08/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
CTS is one of the common
musculoskeletal problems in pregnancy. CTS
occurs mostly in females than in males and maximally the females are affected during the third trimester
The aim of the study was to assess
the prevalence of Carpal Tunnel
Syndrome among third trimester
pregnant women. It was an Observational, Cross-Sectional study.
The
study was carried
out in 246 participants visiting
antenatal care clinic of obstetrics and gynaecology outpatient department at government tertiary care hospital.
After recruiting participants according to the inclusion
and exclusion criteria, written informed consent was taken. Boston Carpal Tunnel
Questionnaire which was the primary
outcome measure was administered in all participants. Secondary outcome measures were then taken. Wrist-to-palm ratio and
wrist ratio will be then calculated
for all the participants. Phalen’s Test and 2 Point Discrimination were taken in those participants who show positive
signs and symptoms of CTS.
Data was collected and descriptive analysis of data was done. The result
of the BCTQ which was the primary
outcome measure showed that 43 (17.47%) participants out of 246 had positive
symptoms for CTS on SSS and only 19(7.7%) participants out of them had affection
in functions as per the FSS.
|