| CTRI Number |
CTRI/2024/12/078165 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| 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
|
Lumbar Spine Rehab Application |
|
Scientific Title of Study
|
Evaluation of efficacy of mobile application based data collection Vs conventional data collection for follow up of functional outcome following Interferential therapy and lower back strengthening exercises for lower back pathology using Oswestry Disability Index scoring system. |
| 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 Rajkumar Balasubramani |
| Designation |
postgraduate in orthopaedics |
| Affiliation |
Saveetha Institute Of Medical And Technical Sciences, Saveetha Medical College And Hospitals |
| Address |
Department of Orthopaedics , Room No 201, Division 1, Saveetha Institute Of Medical And Technical Sciences, Saveetha Medical College And Hospitals, Saveetha Nagar ,Thandalam,Kancheepuram
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8973757708 |
| Fax |
|
| Email |
rajkumarbbalasubramani001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Benjamin Vinodh |
| Designation |
Associate professor in dept of orthopaedics |
| Affiliation |
Saveetha Institute Of Medical And Technical Sciences, Saveetha Medical College And Hospitals |
| Address |
Department of Orthopaedics , Room No 201, Division 1, , Saveetha Nagar ,Thandalam,Kancheepuram
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9445711147 |
| Fax |
|
| Email |
benjaminvinodh91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Raji |
| Designation |
Assistant professor |
| Affiliation |
Saveetha Institute Of Medical And Technical Sciences, Saveetha Medical College And Hospitals |
| Address |
Department of Orthopaedics , Room No 201, Division 1, Saveetha Institute Of Medical And Technical Sciences, Saveetha Medical College And Hospitals, Saveetha Nagar ,Thandalam,Kancheepuram
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8056801972 |
| Fax |
|
| Email |
sanjayn13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics , Room No 201, Division 1, Saveetha Institute Of Medical And Technical Sciences, Saveetha Medical College And Hospitals, Saveetha Nagar ,Thandalam,Kancheepuram Tamilnadu, India ,602105 |
|
|
Primary Sponsor
|
| Name |
Dr Rajkumar Balasubramani |
| Address |
Department of Orthopaedics , Room No 201, Division 1, Saveetha Institute Of Medical And Technical Sciences, Saveetha Medical College And Hospitals, Saveetha Nagar,Thandalam,Chennai,Tamilnadu,
India,602105 |
| Type of Sponsor |
Other [Myself ] |
|
|
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 Rajkumar Balasubramani |
SAVEETHA MEDICAL COLLEGE AND HOSPITALS |
Department of Orthopedics , Room no 201, Division 1
Kancheepuram
TAMIL NADU |
8973757708
rajkumarbbalasubramani001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M498||Spondylopathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Evaluation of efficacy of mobile application based data collection Vs conventional data collection for follow up of functional outcome following Interferential therapy and lower back strengthening exercises for lower back pathology using Oswestry Disability Index scoring system. |
Theis is all about comparing the patients using conventional rehab method and mobile app method to know their lower back pain recovery after doing regular physiotherapy exercises in daily basis , and frequency of getting doctors appointments every two weeks . This study is being conducted for 6 months . |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with chronic lower back pain of more than 3 months.
Currently undergoing interferential therapy and lower back strengthening exercises. |
|
| ExclusionCriteria |
| Details |
Severe neurological deficits.
Recent spinal surgery (within the last 6 months).
Other significant comorbidities affecting mobility or participation. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Oswestry Disability Index (ODI) scores to assess functional outcomes following interferential therapy and lower back strengthening exercises. |
Baseline: Before starting the intervention.
Midpoint: At 3 weeks into the intervention.
Endpoint: At 6 weeks, upon completion of the intervention.
Follow-up: At 12 weeks post-intervention to assess sustained outcomes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adherence to data collection methods, user satisfaction, and completeness of follow-up data using mobile applications versus conventional methods. |
Weekly: Throughout the 6-week intervention period for adherence and data completeness.
Endpoint: At 6 weeks for overall user satisfaction and compliance.
Follow-up: At 12 weeks post-intervention for sustained adherence and satisfaction. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/12/2024 |
| 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 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
|
This research compares the effectiveness of mobile application-based data collection versus conventional methods in monitoring functional outcomes in patients with lower back pathologies undergoing interferential therapy and lower back strengthening exercises. Using the Oswestry Disability Index (ODI) as the primary measure, the study evaluates improvements in disability scores, adherence to data collection, user satisfaction, and completeness of follow-up data. The aim is to determine whether mobile applications can enhance data collection efficiency, patient engagement, and outcome monitoring in rehabilitation care. |