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A pilot study for a prospective randomized clinical trial was conducted to compare subjects using the CCO (Group-A) with those using the ER-splint (Group-B) before and after the intervention.
The primary outcome was difference in the level of pain based on the visual analogue scale (VAS) between before and after intervention in each group during forceful and resting respiration.
VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis
Investigators performed VAS assessments to determine the level of pain in the subjects with RFs during resting and forceful respiration. Investigators applied either the CCO rib splint or the ER splint to the RF subjects in a randomized order. At 30 minutes after splint application, investigators repeated the VAS assessments during resting and forceful respiration. Subsequently, additional pain control was provided via intravascular drug injection.
RF : Rib fractures VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCO Rib Splint | Active Comparator | Subjects were applied Chrisofix® Chest Orthosis (Manufactured Rib Splint) for Rib Fractures treatment. |
|
| Handmade Rib Splint | Experimental | Subjects were applied Handmade Rib Splint for Rib Fractures treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of Rib Splint | Device | Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration | Comparison CCO Rib splint with Handmade Rib splint about pain reduction | We check a pain scale at 30 minutes after splint application |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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