| CTRI Number |
CTRI/2024/03/063771 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| 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
|
Effects of Kinesio Taping and Rigid Taping on Pain, and Running in Athletes with Shin Splints |
|
Scientific Title of Study
|
Acute Effects of Kinesio Taping and Rigid Taping on Pain, and Running Kinematic parameters in Athletes with Shin Splints: 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 |
DrSwapnil RamtekePT |
| Designation |
Professor & HOD,Dept. of Sports PT,RNPC |
| Affiliation |
Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education and Research,Wardha |
| Address |
Department of Sports Physiotherapy,Ravi Nair Physiotherapy College,DMIHER,Sawangi (Meghe),Wardha,Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
07619941787 |
| Fax |
|
| Email |
swapnil123.com@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSwapnil RamtekePT |
| Designation |
Professor & HOD,Dept. of Sports PT,RNPC |
| Affiliation |
Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education and Research,Wardha |
| Address |
Department of Sports Physiotherapy,Ravi Nair Physiotherapy College,DMIHER,Sawangi (Meghe),Wardha,Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
07619941787 |
| Fax |
|
| Email |
swapnil123.com@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Irshad Qureshi PT |
| Designation |
Professor ,Principal |
| Affiliation |
Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education and Research,Wardha |
| Address |
Ravi Nair Physiotherapy College,DMIHER,Sawangi (Meghe),Wardha,Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9406010010 |
| Fax |
|
| Email |
irshadphysio@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha-442001, MH |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi (Meghe), Wardha-442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr SWAPNIL RAMTEKE PT |
AVBRH, |
Room No. 01, Ground Floor, Department of sports physiotherapy,Ravi Nair Physiotherapy College,DMIHER,Sawangi (Meghe),Wardha
Wardha
MAHARASHTRA |
7619941787
swapnil123.com@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group Stretching
Kinesiotaping
|
All stretches to be done for 30 secs, 3 repetitions and 3 consecutive days. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Rigid Taping +Group Stretching |
All stretches to be done for 30 secs, 3 repetitions and 3 consecutive days, K Taping only once on day 1 |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1)Adolescent professional athletes engaged in competitive sports from Wardha district
2)Playing competitive sports for a minimum for one year
3)Point tenderness around shin upon palpation
|
|
| ExclusionCriteria |
| Details |
Stress fractures
Bone tumors,Compartment syndrome
Congenital anomalies
Vascular insufficiencies,
Known allergy to tape, and
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain Pressure Algometer
2. Gait Parameters of step length, cadence by X Sense motion analyser
3. Sprint 50 meter X Sense motion analyser
|
Baseline, Day 1, Day 2 and Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| stride length, |
baseline,day1,day2 |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
19/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [swapnil123.com@gmail.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 01-06-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The anaysis of the parameters is unavailable for Indian population In recent times there
have been studies of using K tape for shin splints to reduce rehab time and
faster return to sports .Rigid arch taping is a new developed concept that
states to be beneficial for shin splints . There is no evidence comparing
the effects of kinesio taping and rigid arch taping on shin splints of runners for detailed kinematic analysis. Thus, more research is required in this area. |