| CTRI Number |
CTRI/2020/11/028781 [Registered on: 02/11/2020] Trial Registered Prospectively |
| Last Modified On: |
23/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Foam rolling to improve the flexibility of low back in people with low back pain." |
|
Scientific Title of Study
|
Immediate effect of foam rolling on the flexibility of thoraco lumbar fascia in people with non specific 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 |
Jyothis Prasad |
| Designation |
PG |
| Affiliation |
M S Ramaiah Medical College |
| Address |
Department of Physiotherapy,
M S Ramaiah Medical College,
MSRIT post,
Bangalore
560054.
Department of Physiotherapy,
M S Ramaiah Medical College,
MSRIT post,
Bangalore
560054.
Bangalore
KARNATAKA
560054
India |
| Phone |
8943960081 |
| Fax |
|
| Email |
jyothisprasad14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soni S |
| Designation |
Associate Professor |
| Affiliation |
MS RAMAIAH MEDICAL COLLEGE |
| Address |
Department of Physiotherapy,
MS Ramaiah Medical College
MSRIT post
Bangalore
560054
Department of Physiotherapy,
MS Ramaiah Medical College
MSRIT post
Bangalore
560054
Bangalore
KARNATAKA
560094
India |
| Phone |
9740390880 |
| Fax |
|
| Email |
soni@msrmc.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Jyothis Prasad |
| Designation |
Postgraduate |
| Affiliation |
MS RAMAIAH MEDICAL COLLEGE |
| Address |
No.33, 3rd main road, Ayyappa layout, opposite police quarters, Hebbal, Bangalore
Department of Physiotherapy,
MS Ramaiah Medical College
MSRIT post
Bangalore
560054
Bangalore
KARNATAKA
560054
India |
| Phone |
8943960081 |
| Fax |
|
| Email |
jyothisprasad14@gmail.com |
|
|
Source of Monetary or Material Support
|
| M S RAMAIAH MEDICAL COLLEGE AND HOSPITALS |
|
|
Primary Sponsor
|
| Name |
Jyothis Prasad |
| Address |
Department of Physiotherapy,
MS Ramaiah Medical College
MSRIT post
Bangalore
560054 |
| 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 |
| Jyothis Prasad |
M S RAMAIAH HOSPITALS |
Department of Physiotherapy,
MS Ramaiah hospital
Bangalore
KARNATAKA |
8943960081
jyothisprasad14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MSRMC ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Foam Rolling |
first the investigator will demonstrate the foam rolling procedure to the lower back in detail to the subject after which the subject has to do the intervention on his own while the investigator monitors it.Foam rolling will be given in 3 sets of 45 seconds each with a rest period of 30 seconds in between using low cadence and pressure as tolerable by the subject. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
diagnosis of low back pain within the last 6 months, numerical pain rating scale ranging from 4-8 for determination of pain level, lumbar flexion range of motion less than 50 degrees. |
|
| ExclusionCriteria |
| Details |
Radicular pain, spinal injuries, SI joint dysfuction, surgeries of spine, hip, knee or ankle , on a regular medication of non steroidal or anti-inflammatory drugs, lower limb fractures,people weighing more than 120 kgs |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Schobers test |
Pre and Post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale |
Pre and Post intervention |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
05/11/2020 |
| 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="1"
Months="0"
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)?
Response - NO
|
|
Brief Summary
|
The study is to check the immediate effect of foam rolling to the thoraco-lumbar fascia whether it improves the lumbar flexion range of motion or no. 23 Subjects who fits the inclusion criteria with non specific low back pain and no other co-morbidities to the back are selected for this intervention study. Pre-test visual analogue scale and modified schober’s test are used as the outcome measure in this study. The subject has to perform foam rolling to the back for 3 sessions of 45 seconds each with a rest period of 15 seconds between them immediately after which the visual analogue scale and modified schobers’s test are taken again to check for the change in the lumbar flexion range of motion. There are no associated risk with the study and it is a pre-post intervention study. |