CTRI

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CTRI Number

CTRI/2018/03/012490 [Registered on: 12/03/2018] Trial Registered Retrospectively

Last Modified On:

15/03/2018

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

Effectiveness of two manual therapy techniques: instrument assisted soft tissue mobilisation technique versus Mulligan technique on hamstring tightness

Scientific Title of Study

Short term effect of Instrument Assisted Soft tissue mobilization (M2T blade) versus Mulligans Bent Leg Raise technique in asymptomatic subjects with Hamstring tightness A Randomised 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	Radhika Chintamani
Designation	Master of Orthopaedic Manual Therapy.
Affiliation	KLE Academy of Higher Education And Research
Address	KLE University Institute of Physiotherapy Nehru Nagar Belagavi KLE Academy of Higher Education And Research, institute of Physiotherapy, Nehru Nagar Belagavi Belgaum KARNATAKA 590010 India
Phone	8762184039
Fax
Email	radds2009@gmail.com

Details of Contact Person
Scientific Query

Name	Radhika Chintamani
Designation	Master of Physiotherapy-Orthopaedic Manual Therapy.
Affiliation	KLE Academy of Higher Education And Research
Address	KLE University Institute of Physiotherapy Nehru Nagar Belagavi Belgaum KARNATAKA 590010 India
Phone	8762184039
Fax
Email	radds2009@gmail.com

Details of Contact Person
Public Query
Modification(s)

Name	Santosh Metgud
Designation	Head of department Orthopaedic Manual therapy department number 13
Affiliation	Head of department Orthopaedic manual therapy department number 13
Address	KLE Academy of Higher Education and Research, Institute of Physiotherapy Nehru Nagar Belagavi KLE University Institute of Physiotherapy Nehru Nagar Belagavi Belgaum KARNATAKA 590010 India
Phone	9164646484
Fax
Email	metgud_santosh@yahoo.co.in

Source of Monetary or Material Support

Self funded Radhika Chintamani KLE University Institute of Physiotherapy Nehru Nagar Belagavi

Primary Sponsor

Name	Radhika Chintamani
Address	KLE University Institute of Physiotherapy Nehru Nagar Belagavi
Type of Sponsor	Other [Self funded]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Radhika Chintmani	KLE University Institute of Physiotherapy Belagavi	Orthopedic Manual Therapy department,room number: 13. KLE University Institute of Physiotherapy Nehru Nagar Belagavi Belgaum KARNATAKA	8762184039 radds2009@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Research and ethical committee KLEU institute of Physiotherapy BELAGAVI	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Asymptomatic subjects with Hamstring tightness

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Group A: instrument assisted soft tissue mobilisation technique M2T blade along with static stretching	30 strokes using M2T blade was given for the part felt to be tight of hamstring after assessing with the blade itself which approximated for 30 seconds. And stretching of 90 seconds hold time and 30 second rest time for 5 repetitions Total duration of the treatment was 10.5 minutes
Comparator Agent	Group B: Mulligans Bent leg raise technique along with static stretching	Mulligans Bent leg raise technique was performed and the end position reached was held for Upto 20 seconds. And stretching of 90 seconds hold time and 30 second rest time for 5 repetitions. Total duration of the treatment was 10.3 minutes

Inclusion Criteria

Age From	18.00 Year(s)
Age To	25.00 Year(s)
Gender	Both
Details	1. Asymptomatic subjects with Hamstring tightness 2. Minimum of 20 degrees of knee flexion while performing AKT unilaterally 3. Subjects willing to participate

ExclusionCriteria

Details

1. Hypersensitive skin
2. Diagnosed Malignancy (local, active)
3. Any diagnosed neurological deficits
4. Any local skin disease
5. Any traumatic injury to knee joint and lumbar spine less than 6 months

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Popliteal angle Active knee extension test Sit and reach test Lumbar lordosis index using Flexi curve	Pre treatment and twenty four hour post treatment values of all the outcomes were noted down

Secondary Outcome

Outcome	TimePoints
Nil	Nil

Target Sample Size

Total Sample Size="212"
Sample Size from India="212"
Final Enrollment numbers achieved (Total)= "212"
Final Enrollment numbers achieved (India)="212"

Phase of Trial

Phase 2

Date of First Enrollment (India)

30/05/2017

Date of Study Completion (India)

04/01/2018

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="1"
Days="1"

Recruitment Status of Trial (Global)

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

Present study is a comparative study between instrument assisted soft tissue mobilisation technique (M2T blade) versus Mulligan’s Bent Leg raise technique in asymptomatic subjects with Hamstring tightness. It is a pre-post trial where the outcome measures were assessed pre-intervention that is baseline values and after 24hours of intervention. Outcome measures targeted both knee extension range actively and passively, and lumbar motion along with degree lumbar lordosis.