| CTRI Number |
CTRI/2025/04/084326 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| 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
|
Comparing the effect of IASTM, Cryostretch and Tissue Flossing on Pain and Function in People with Calf tightness. |
|
Scientific Title of Study
|
To Compare the Effectiveness Of Instrument Assisted Soft Tissue Mobilization (IASTM), Cryostretch and Tissue Flossing On Pain and Functional Disability in subjects with Calf Tightness among Young Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alisha Kamboj |
| Designation |
MPT Orthopedics Student |
| Affiliation |
Guru Nanak Dev University Amritsar , Punjab affiliated under UGC ,PCI,BCI ,COA,NCTE |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar , Punjab, India
Amritsar
PUNJAB
143005
India |
| Phone |
9501472001 |
| Fax |
|
| Email |
alishakamboj1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manpreet Bir Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University Amritsar , Punjab affiliated under UGC ,PCI,BCI ,COA,NCTE |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar , Punjab, India
Amritsar
PUNJAB
143005
India |
| Phone |
9988333506 |
| Fax |
|
| Email |
manpreet.physio@gndu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Manpreet Bir Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University Amritsar , Punjab affiliated under UGC ,PCI,BCI ,COA,NCTE |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar , Punjab, India
Amritsar
PUNJAB
143005
India |
| Phone |
9988333506 |
| Fax |
|
| Email |
manpreet.physio@gndu.ac.in |
|
|
Source of Monetary or Material Support
|
| Health Centre (Physiotherapy Centre), Guru Nanak Dev University, Amritsar, Punjab, India-143005 |
|
|
Primary Sponsor
|
| Name |
Alisha Kamboj |
| Address |
Department of Physiotherapy, Guru Nanak Dev University, Amritsar, Punjab, India- 143005 |
| 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 |
| Alisha Kamboj |
University Health Centre, Physiotherapy unit |
Room no 8, Ground Floor, Guru Nanak Dev University, Grand Trunk Road, Off NH1, Amritsar, Punjab - 143005
Amritsar
PUNJAB |
9501472001
alishakamboj1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Guru Nanak Dev University, Amritsar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with calf tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cryostretch |
Cryostretch is a treatment method that includes a combination of cryotherapy and stretching which is given for releasing soft tissues.
Frequency: 2 Sessions per week
Duration: Ice is applied for 15 minutes until numb.
Calf stretch is held for 20
seconds.
There is a 5 second relaxation period after each stretch.
This process is repeated 3 times |
| Intervention |
Instrument Assisted Soft Tissue Mobilization (IASTM) |
IASTM is specialized soft tissue mobilization technique that uses instruments to apply longitudinal pressure along muscle fibres.
Frequency: 2 Sessions per week
Duration: 5 Minutes per session
|
| Intervention |
Tissue Flossing |
Tissue Flossing is a technique which involves the wrapping of thick rubberband around joint or muscle partially occluding blood flow while often concomitantly performing range of motion task.
Frequency: 2 Sessions per week
Duration: 2 Minutes per session |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with calf tightness ( Gastrocnemius and Soleus) |
|
| ExclusionCriteria |
| Details |
Subjects with history of lower extremity injury in past 6 months.
subjects with deformities( Flat foot, Club Foot, Pes Planus, Pes Cavus)
Subjects with cardiac conditions (Peripheral Arterial Disease)
Subjects with neurological conditions (Stroke, Epilepsy)
Subjects with skin problems (Psoriasis, Vitiligo, rashes, active dermatitis) |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Calf tightness
|
Baseline and after 2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain ,Functional Disability |
Baseline and after 2 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/04/2025 |
| 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="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will compare the effects of IASTM, Cryostretch and Tissue Flossing on pain and functional disability. Total subjects will be divided into 3 groups. IASTM will be given 2 times a week to group1 , Cryostretch will be given 2 times a week to group 2 and tissue flossing will be given 2 times a week to group 3. Total duration of treatment for all three groups will be 1 week. |