| CTRI Number |
CTRI/2020/10/028611 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
01/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effect of an instrument versus foam roller on pain areas in calf muscles |
|
Scientific Title of Study
|
Effectiveness of instrument assisted soft tissue mobilization versus foam rolling on trigger point release in calf muscles |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amita Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiotherapy Ist cabin ,3rd floor,Dr. D.Y.Patil College of Physiotherapy,Sant Tukaram Nagar, Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amita Aggarwal |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Department of Kinesiotherapy Ist cabin ,3rd floor,Dr. D.Y.Patil College of Physiotherapy,Sant Tukaram Nagar, Pimpri,Pune.
MAHARASHTRA
411018
India |
| Phone |
7986972513 |
| Fax |
|
| Email |
amita15pgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nehal Agarwal |
| Designation |
PG Student |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
PG-2 Classroom,3rd floor,Dr. D.Y. Patil College of
Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411018
India |
| Phone |
9767676910 |
| Fax |
|
| Email |
anehal16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr DY Patil college of Physiotherapy, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Amita Aggarwal |
| Address |
Flat No. 1004 A wing Kamalraj Haridwar Society,Dighi,Pune 411015 |
| 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 |
| Amita Aggarwal |
Dr D.Y.Patil College of Physiotherapy,Pimpri,P une |
Department of
Kinesiotherapy 1st
CABIN, 3rd floor, D. Y.
Patil College of
Physiotherapy. Sant
Tukaram Nagar, Plot
No. BGP/190,
Pimpri-Chinchwad,
Maharashtra 411018
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
7986972513
amita15pgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y. Patil Vidyapeeth ,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Calf trigger points |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foam rolling |
Foam rolling will be given in multiple directions on calf muscles,first on right side,2 sets,each set with 30 repetitions(approximately 2 minutes) and then left side.
(total 3 sessions on alternate days for a total of 6 days ) |
| Intervention |
Instrument assisted soft tissue mobilization |
30 to 60 degrees angle of IASTM over both calf muscles
(total 3 sessions on alternate days for a total of 6 days ).4 minutes of treatment duration-2 minutes for right calf and 2 minutes for left calf |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1) Both normal healthy male and female willing to participate.
2) Age 18 to 25 years of age.
3) Diagnosed and undiagnosed Restriction in passive or active dorsiflexion <10º.
4) 1 or more Trigger points of calf in bilateral limbs.
5) WBLT >1.5cm lunge asymmetry. |
|
| ExclusionCriteria |
| Details |
1) Inability to lie in prone position.
2) Recent history of ankle sprain or fracture
3) Skin infection- dermatitis, cellulitis, ulcers
4) Injuries affecting soft tissue structures near the treatment area.
5) Unknown heart conditions.
6) Acute shoulder injuries
7) Complain of shoulder weakness
8) Low back pain and radiculopathies
9) Fibromyalgia syndrome.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Weight bearing lunge test(WBLT)
Universal goniometer
Pressure Algometer |
first and sixth day of assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vertical jump test |
first and sixth day of assessment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
31/10/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effectiveness of instrument assisted soft tissue mobilization versus
foam rolling on trigger point release in calf muscles OBJECTIVE: 1. 1.To
find the effect of IASTM on ankle dorsiflexion range of motion, pressure pain
threshold and power. 2. 2. To
study the effect of Foam Rolling on ankle dorsiflexion range of motion, pressure
pain threshold and power. 3. 3. To
compare the effect of IASTM vs Foam rolling on ankle dorsiflexion range of
motion, pressure pain threshold and power. METHODOLOGY:
Based on the inclusion and exclusion criteria the
subjects will be divided in 2 groups.Group A will be treated using IASTM and
Group B will be given foam rolling.Pre and post treatment weight bearing lunge
test, universal goniometer, pressure algometer and vertical jump test will
be recorded on first day and 6th day. |