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CTRI Number  CTRI/2024/05/066938 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Non Invasive pain management ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain relief after kinesiology tape application in rib fracturs 
Scientific Title of Study   Comparative evaluation of Kinesiotaping and Conventional Management versus Conventional Management alone in detecting pain in patients with thoracic trauma: A Randomised Controlled Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinod Kumar Saini 
Designation  McH,Senior Resident 
Affiliation  JPNATC, AIIMS, New Delhi 
Address  Hostel 17 Ambuja hostel JPN Apex Trauma Centre AIIMS, New Delhi 011-26731070
JPN Apex Trauma Centre AIIMS, New Delhi
New Delhi
DELHI
110029
India 
Phone  08866078074  
Fax    
Email  sainivinod531@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Subodh Kumar 
Designation  Professor 
Affiliation  JPNATC, AIIMS, New Delhi 
Address  Room No.227 2nd Floor JPN Apex Trauma Centre AIIMS, New Delhi 011-26731070

New Delhi
DELHI
110029
India 
Phone  09810202776  
Fax    
Email  subodh6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Subodh Kumar 
Designation  Professor 
Affiliation  JPNATC, AIIMS, New Delhi 
Address  Room No.227 2nd Floor JPN Apex Trauma Centre AIIMS, New Delhi 011-26731070
Room No.227 2nd Floor JPN Apex Trauma Centre AIIMS, New Delhi 011-26731070
New Delhi
DELHI
110029
India 
Phone  09810202776  
Fax    
Email  subodh6@gmail.com  
 
Source of Monetary or Material Support  
JPN Apex Trauma Centre AIIMS, New Delhi 011-26731070 
 
Primary Sponsor  
Name  JPN Apex Trauma Centre AIIMS 
Address  JPN Apex Trauma Centre AIIMS, New Delhi 011-26731070 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Subodh Kumar  JPN Apex Trauma Centre, AIIMS  JPN Apex Trauma Centre AIIMS, New Delhi 011-26731070
New Delhi
DELHI 
09810202776

subodh6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S224||Multiple fractures of ribs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional group (Ct group)  Conventional Management alone in detecting pain in patients with thoracic trauma 
Intervention  Kinesio group (Kt group)  Kinesiotape and Conventional Management in detecting pain in patients with thoracic trauma 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age 18-65years
2.Isolated chest trauma patients without need for ICD
3.Involving up to 5 rib fracture either side
4.Presenting within 24 hours of their injuries
 
 
ExclusionCriteria 
Details  1.Patients on mechanical ventilator
2.Patients with more than 5 rib fractures unilaterally or 1st ,2nd and 12th rib fracture
3.Flail Chest
4.Patients with chest trauma who need ICD.
5.Patients with comorbidities like diabetes, dermatological disorders, and hematological disorders.
• Female patient having anterior rib fracture
• Patients who have not given consent for the study
 
 
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. To compare pain score on visual analogue score (VAS) after kinesiotaping along with conventional management vs pain score with conventional management only.  Baseline
6 hours
12 hours
24 hours
48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Pulmonary function test
Sequential clinical assessment of respiratory function (SCARF score) 
Baseline
6 hours
12 hours
48 hours 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   17/05/2024 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [subodh6@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 30-09-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

The most common injury in blunt thoracic trauma is chest wall injury, which includes rib fractures. 90% of these cases are managed non-operatively. Pain control is the mainstay of treatment which helps to improve pulmonary function and reduce associated complications. Only analgesics like the non-steroidal anti-inflammatory drugs (NSAIDS) opioids have numerous pharmacological side effects. In various studies done on opioids, depicts their dependence, withdrawal and various other complications. There exists girth in quality literature studying the role of non-pharmacological interventions like kinesiotaping in providing pain relief in chest trauma patients. Kinesiotaping (KT) is drug free elastic therapeutic tape used for various musculoskeletal problems such as injury, dysfunction, and pain.  KT is a thin elastic tape that stretches to 120-140 % of its original length, and then subsequently recoils back to its original length, exerting a proposed pulling force to the skin. However, the exact mechanism of KT is unclear, investigators assert several mechanisms such as supporting injured muscles and joints, improving fascia function and position, increasing segmental stability, activation of the blood and lymph flow by lifting the skin, decreasing pain by reducing nociceptive stimuli. The structure of the tape and the application technique result in the therapeutic effects of kinesiology taping. These effects include improving circulation of the blood and lymph, decreasing pain, stimulating proprioception, stabilizing particulars and restoring muscle tone. It was significantly popular after it was seen on athletes at 2008 Olympic Games. KT has been evaluated in several studies for low back pain and other musculoskeletal injuries especially in sports medicine. So, recent studies have shown that use of KT along with conventional analgesia is associated with reduction in pain in isolated rib fracture in thoracic trauma patient.


 
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