| CTRI Number |
CTRI/2020/04/024657 [Registered on: 15/04/2020] Trial Registered Prospectively |
| Last Modified On: |
07/04/2020 |
| 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
|
A clinical trial to find the effectiveness of varied biofeedback training on the transverse abdominis muscle thickness in subjects with low back pain |
|
Scientific Title of Study
|
Varied biofeedback training on the Transverse abdominis muscle thickness in Low back pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janani V |
| Designation |
Post graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],
Porur,
Chennai
Tamil nadu
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9841047567 |
| Fax |
|
| Email |
jananisince1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR P ANTONY LEO ASSER |
| Designation |
Professor and Vice Principal |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],
Porur,
Chennai.
Tamil nadu
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9841544303 |
| Fax |
|
| Email |
antonyleo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR P ANTONY LEO ASSER |
| Designation |
Professor and Vice Principal |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],
Porur,
Chennai
Tamil nadu
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9841544303 |
| Fax |
|
| Email |
antonyleo@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Rehabilitation department, Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],
Porur,
Chennai.
Tamil nadu
India
|
|
|
Primary Sponsor
|
| Name |
Ms Janani V |
| Address |
Sri Ramachandra Institute of Higher Education and Research
[Deemed to be university]
Porur Chennai 600 116
Tamil Nadu India
|
| 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 |
| MS V JANANI |
Physical Rehabilitation Department |
Faculty of Physiotherapy,
Sri Ramachandra Institute of Higher Education and Research,
[Deemed to be university]
Porur, Chennai – 600 116, Tamil Nadu, India
Chennai
TAMIL NADU |
9841047567
jananisince1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECCTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
standard exercise |
routine back strengthening exercises |
| Intervention |
varied biofeedback |
visual biofeedback
auditory biofeedback
tactile biofeedback |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with mechanical low back pain |
|
| ExclusionCriteria |
| Details |
1. History of fracture or Surgical intervention for low back
2. Systemic red flags
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Real time ultrasound imaging on Transverse abdominis muscle thickness at rest and at isometric contraction |
At baseline and at end of third week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The clinical measures of numeric pain rating scale, core muscle strength using pressure biofeedback |
At baseline and at end of third week |
|
|
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)
|
15/04/2020 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is randomized, single blinded, clinical trial comparing the effectiveness of varied biofeedback training, its impact on transverse abdominis muscle in subjects with low back pain from Sri Ramachandra institute of higher education and research, porur, chennai, India. patients fulfilling the selection criteria and signing the informed consent form will be taken up for the study and will be randomly categorized in to 2 groups( control and experimental). control group will receive standard physiotherapy exercises to strengthen the low back muscles and experimental group will receive varied biofeedback training following which baseline values and post exercise 3weeks values are taken and analysed. |