| CTRI Number |
CTRI/2021/12/038885 [Registered on: 23/12/2021] Trial Registered Prospectively |
| Last Modified On: |
22/12/2021 |
| 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
|
Effect of telerehabilitation and home-based exercise program on postpartum women with low back pain. |
|
Scientific Title of Study
|
Effectiveness of telerehabilitation and home-based exercise program on pain, disability, self-efficacy and coping in postpartum low back pain – A Randomised 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 |
Lakshada Nayak |
| Designation |
Post Graduate Physiotherapy Student |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM College Of Physiotherapy OPD NO - 5 Department Of Orthopaedics Physiotherapy Manjushreenagar, Sattur Dharwad Karnataka India. 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
08806373626 |
| Fax |
|
| Email |
lakshadanayak22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lakshada Nayak |
| Designation |
Post Graduate Physiotherapy Student |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM College Of Physiotherapy OPD NO - 5 Department Of Orthopaedics Physiotherapy Manjushreenagar, Sattur Dharwad Karnataka India. 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
08806373626 |
| Fax |
|
| Email |
lakshadanayak22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
SDM college of Physiotherapy |
| Address |
SDM College Of Physiotherapy OPD NO - 5 Department Of Orthopaedics Physiotherapy Manjushreenagar, Sattur Dharwad Karnataka India. 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9886276543 |
| Fax |
|
| Email |
dr.shweta07@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of Physiotherapy, Department of orthopedic physiotherapy OPD no. 5 manjushreenagar sattur Dharwad Karnataka |
|
|
Primary Sponsor
|
| Name |
Lakshada Nayak |
| Address |
SDM College Of Physiotherapy Manjushreenagar, Sattur Dharwad Karnataka India. 580009 |
| 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 |
| Lakshada Nayak |
SDM college of medical sciences and hospital |
Department Of Orthopaedics Physiotherapy OPD NO - 5 Manjushreenagar, Sattur Dharwad Karnataka India. 580009
Dharwad
KARNATAKA |
08806373626
lakshadanayak22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee permission |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Participants will receive Telerehabilitation
Intervention. |
| Comparator Agent |
Group B |
Participants will receive Home Based Exercise
Programme |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Women pointing at low back area on the body chart and who fits the definition of postpartum
low back pain i.e., a pain in the lower lumbar region and is multifactorial in nature.
2)Women between the age group of 18-35 years.
3)All the postpartum women ranging from 3rd–6th month.
4)Cesarean or vaginal delivery.
5)women who are living in the area served by high-speed internet services |
|
| ExclusionCriteria |
| Details |
1)Women not willing to give the consent
2)Radiculopathy.
3)Known case of Systemic diseases/ gynaecological diseases / tumour/ infection
4)Known case of spinal/congenital deformities/fracture
5)Psychiatric illness
6)Any previous lumbar or abdominal surgery except caesarean Section.
7)women who are not living in the area served by high-speed internet services or does not have
the feature of video calling in their cell phones. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nordic Body chart.
Visual Analog Scale.
Oswestry Disability Questionnaire.
Pain self-efficacy Questionnaire.
Coping Strategies Questionnaire-Revised. |
at the baseline E1 (first day in the hospital, Pre intervention) and E2(at the last session i.e., 4th week) respectively for both the groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
27/12/2021 |
| 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
|
Not Yet |
|
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 to find out the effectiveness of telerehabilitation and home-based exercise program on pain, disability, self-efficacy, and coping in postpartum women with low back pain. In this randomized controlled trial, subjects between the age group of 18-35 years with postpartum low back pain will be included. Subjects will be assessed for pain intensity, disability, self-efficacy, and coping. Subjects will be allocated to the groups using sealed opaque envelopes. The investigator and subjects will be blinded. Participants will receive 8 treatment sessions for 4 weeks (2 sessions per week for both groups). Each session will be of 30-45 minutes. Group A will receive Telerehabilitation Intervention under the therapist’s supervision (where the therapist will demonstrate the exercises via WhatsApp videoconference and same will be done by the Participant) and Group B will receive a Home-Based Exercise Program where the subject will be taught exercises on the first day and will be given a booklet containing a set of exercises for 4 weeks, the therapist will make a call to the subject weekly once for 4week to check the adherence to the protocol. Assessment of outcome measures will be done at the baseline E1 (first day in the hospital, Pre-intervention) and E2(at the last session i.e., 4th week) respectively for both the groups. |