| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [subodh6@gmail.com].
- 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.
- 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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