| CTRI Number |
CTRI/2020/03/023972 [Registered on: 16/03/2020] Trial Registered Prospectively |
| Last Modified On: |
27/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study to know the effect of TENS machine on pain and daily activities following Cesarean delivery |
|
Scientific Title of Study
|
"Influence of Transcutaneous Electrical Nerve Stimulation on pain pattern and functional activities following Lower Segment Cesarean Section" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kiransha R Velingkar |
| Designation |
Post graduate student pursuing MPT in OBG |
| Affiliation |
Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Physiotherapy, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8884953056 |
| Fax |
|
| Email |
kiranvelingkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhamini Krishna Rao |
| Designation |
Professor |
| Affiliation |
Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Physiotherapy, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9480267152 |
| Fax |
|
| Email |
bhamini.kr@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhamini Krishna Rao |
| Designation |
Professor |
| Affiliation |
Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Physiotherapy, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9480267152 |
| Fax |
|
| Email |
bhamini.kr@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kiransha R Velingkar |
| Address |
Department of Physiotherapy, Manipal College Of Health Professions, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Kiransha R Velingkar |
Kasturba Hospital, Manipal |
Department of OBG and Gynecology,
OBG wards ,
Wards WH4 AND WH5
Udupi
KARNATAKA |
8884953056
kiranvelingkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Application of Transcutaneous Electrical Nerve Stimulation (TENS) modality will be used to reduce pain. Electrodes will be applied at 2cm above and 2cm below the cesarean section incision site. Standard medical and Physiotherapy treatment will be ongoing |
Transcutaneous Electrical Nerve Stimulation (TENS) modality will be used. Electrodes will be applied at 2cm above and 2cm below the cesarean section incision site with intensity as tolerated by the patient and within comfortable limits for 30 minutes. |
| Comparator Agent |
In the control group Standard Physiotherapy and medical treatment will be on going and pain will be assessed using NPRS (Numerical Pain Rating Scale) and Functional activities will be assessed using Patient Specific Functional Scale (PSFS) |
Pain will be assessed using NPRS (Numerical Pain Rating Scale) and Functional activities will be assessed using Patient Specific Functional Scale (PSFS). No TENS treatment will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Postnatal women following Lower Segment Cesarean Section delivery. On the Numerical Pain Rating Scale greater or equal to 4 |
|
| ExclusionCriteria |
| Details |
Mothers with baby admitted to NICU.
Mothers who delivered twins/ triplets/ quadruplets.
Mothers with cardiac pacemakers, morbid obesity, preeclampsia and eclampsia.
Epidural analgesics.
Skin injuries or sensitive skin and alergy to electrodes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical Pain Rating Scale (NPRS) |
8 times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Specific Functional Scale (PSFS) |
4 times |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2020 |
| Date of Study Completion (India) |
01/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Quasi Experimental Design aiming to find the influence of Transcutaneous Electrical Nerve Stimulation on pain pattern and functional activities following Lower Segment Cesarean Section (LSCS) which will be conducted in postnatal wards of Kasturba Hospital, Manipal, Karnataka , India. 50 patients will be recruited among which 25 will be for control and 25 will be for intervention group. The intervention group will receive TENS treatment for 4 days following LSCS .Standard physiotherapy and medical care will be provided for both the groups. Numerical Pain Rating Scale and Patient-Specific Functional Scale are the outcomes measures which will be administered in both the groups for a period of 4 days following Lower Segment Cesarean Section Delivery. |