| CTRI Number |
CTRI/2018/01/011436 [Registered on: 19/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Mulligans BLR technique versus M2T blade technique in people with hamstring muscle tightness in non specific low back ache. |
|
Scientific Title of Study
|
Comparison of Mulligans bent leg raise [BLR] versus instrument assisted soft tissue mobilization [M2T] in subjects with hamstring tightness in non-specific low back ache: A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjana k s |
| Designation |
postgraduate student |
| Affiliation |
KLE Universitys Institute of Physiotherapy, Belagavi |
| Address |
PG student, Department of Orthopedic Manual Therapy, KLEU Institute of Physiotherapy, JNMC Campus, Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9686764951 |
| Fax |
|
| Email |
sanjanaks.2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Heggannavar |
| Designation |
Associate Professor |
| Affiliation |
KLE Universitys Institute of Physiotherapy, Belagavi |
| Address |
Dr. Anand Heggannavar,
Associate Professor,
Department of Orthopedic Manual Therapy,
KLEU Institute of Physiotherapy, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
anandhegs@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanjana k s |
| Designation |
postgraduate student |
| Affiliation |
KLE Universitys Institute of Physiotherapy, Belagavi |
| Address |
PG student, Department of Orthopedic Manual Therapy, KLEU Institute of Physiotherapy, JNMC Campus, Belagavi, Karnataka.
PG student, Department of Orthopedic Manual Therapy, KLEU Institute of Physiotherapy, JNMC Campus, Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9686764951 |
| Fax |
|
| Email |
sanjanaks.2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjana K S, post graduate student, Department of Orthopedic Manual Therapy,KLEU Institute of Physiotherapy, Belagavi, Karnataka. |
|
|
Primary Sponsor
|
| Name |
Sanjana k s |
| Address |
#52/94/3,siri, 3rd main, bank of baroda colony, puttenahalli, j.p.nagar, 7th phase, bengaluru 78 |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Sanjana k s |
Tertiary health care centers, Belagavi |
Dr.Prabhakar Kore charitable hospital, Belagavi
Belgaum
KARNATAKA |
9686764951
9686764951
sanjanaks.2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of KLEUs Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Non specific low back ache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 : BLR
GROUP 2 : M2T |
BLR is a Mulligan mobilization technique
M2T is a blade like instrument to mobilize soft tissue. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects clinically diagnosed with non specific low back ache
Hamstring tightness- active knee extension test AKET- Popliteal angle less than 125 degrees
18 to 40 years of age males and females
Subjects who are willing to participate. |
|
| ExclusionCriteria |
| Details |
Surgeries of lumbar spine
Radiating pain
Neurological deficits
Tumors
Spondylolisthesis
Ankylosing spondylitis
TB spine
Any systemic infections |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale [NPRS]
Active knee extension test [AKET]
Lordosis index
Quebec back pain disability scale [QBPDS] |
pre intervention day 1
post intervention day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale [NPRS]
Active knee extension test [AKET]
Lordosis index
Quebec back pain disability scale [QBPDS] |
pre intervention day 1
post intervention day 5 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/05/2017 |
| Date of Study Completion (India) |
23/02/2018 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Non specific low back ache and hamstring muscle tightness are correlated.So this study is been undertaken to compare if Mulligan’s BLR technique is better or Instrument assisted soft tissue mobilization [M2T] is better in subjects with hamstring tightness in treating non specific low back ache subjects. |