| CTRI Number |
CTRI/2020/12/029591 [Registered on: 04/12/2020] Trial Registered Prospectively |
| Last Modified On: |
15/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cupping Therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ice-Cupping Therapy on Shin Splints in Athletes |
|
Scientific Title of Study
|
Effect of Cryo-Cupping on Medial Tibial Stress Syndrome in Athletes- A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soniya Lohana |
| Designation |
MPT Student |
| Affiliation |
KLEU |
| Address |
Sports OPD, Department of Sports Physiotherapy, KLEU University, Nehru Nagar, Belgaum
Sports OPD, Department of Sports Physiotherapy,KLEU University, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590001
India |
| Phone |
9890630796 |
| Fax |
|
| Email |
soniyatlohana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Basavaraj Motimath |
| Designation |
Associate Professor |
| Affiliation |
KLEU |
| Address |
Department of Sports Physiotherapy, KLEU University, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590001
India |
| Phone |
9890630796 |
| Fax |
|
| Email |
bsmotimath@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Soniya Lohana |
| Designation |
MPT Student |
| Affiliation |
KLEU |
| Address |
Department of Sports Physiotherapy, KLEU University, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590001
India |
| Phone |
9890630796 |
| Fax |
|
| Email |
soniyatlohana@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KLE University |
| Address |
KLEU, Nehru Nagar, Belgaum |
| Type of Sponsor |
Other [Research Institute and Hospital as well as Private Medical College] |
|
|
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 |
| Soniya Lohana |
KLE Hospital |
Department of Sports Physiotherapy, KLE University, Nehru Nagar, Belgaum
Belgaum
KARNATAKA |
9890630796
soniyatlohana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee, KLE Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95||Other acquired deformities of musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cryo-Cupping |
Static or Dynamic Cupping Therapy is given with ice cube put inside the cup and is known as cryo-cupping
Static cupping 5-7 mins
Dynamic cupping- 3 strokes and 2 times
Treatment duration- 2 weeks/ every alternate day i.e 6 sessions |
| Comparator Agent |
Cryotherapy |
Ice-pack will be given on the area of pain that is on the shin.
Ice pack applied for 7-10 mins
Treatment duration- 2 weeks i.e 6 sessions in total |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Track and field athletes participating actively
Athletes presenting with Dull Aching Exercise induced Pain over the medial border of tibia over a length of more than or equal to 5 centimeters |
|
| ExclusionCriteria |
| Details |
Recent fractures or open wounds
Diagnosed Hematological Conditions
Diagnosed Dermatological Conditions including skin infections especially on the lower leg.
Individuals not willing to participate. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain by Visual Analog Scale and Pain Pressure Threshold (PPT) |
1-10 and PPT in kilograms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 60 meter Sprint Test |
in seconds |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/12/2020 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Athletes experience shin pain or Medial Tibial Stress Syndrome due to variation in their training intensity and are forced to play less due the pain. Medial Tibial Stress Syndrome may hamper the athlete’s ability to win and perform better in his game. Therefore, a method of treating this may be necessary. Cryotherapy is effective in reducing pain as well as cupping therapy is helpful in releasing tissues thus cryo-cupping may have a beneficial effect on shin splints that athletes experience. Thus this study is taken up. |