CTRI/2024/05/066938Not yet recruitingPhase 1/2
Comparative evaluation of Kinesiotaping and Conventional Management versus Conventional Management alone in detecting pain in patients with thoracic trauma: A Randomised Controlled Trial
JPN Apex Trauma Centre AIIMS1 site in 1 country50 target enrollmentStarted: May 17, 2024Last updated:
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 1. To compare pain score on visual analogue score (VAS) after kinesiotaping along with conventional management vs pain score with conventional management only.
Study Overview
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. |
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •â€¢ Female patient having anterior rib fracture • Patients who have not given consent for the study.
Outcomes
Primary Outcomes
1. To compare pain score on visual analogue score (VAS) after kinesiotaping along with conventional management vs pain score with conventional management only.
Time Frame: Baseline | 6 hours | 12 hours | 24 hours | 48 hours
Secondary Outcomes
- Pulmonary function test(Sequential clinical assessment of respiratory function (SCARF score))
Investigators
Dr Vinod Kumar Saini
JPNATC, AIIMS, New Delhi
Study Sites (1)
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