Trials / Unknown
UnknownNCT03210792
Comparison Manufactured Rib Splint With Hand-made Rib Splint
Comparison of the Effectiveness in Pain Reduction Between a Rib Splint Produced in the ER and a Manufactured Rib Splint: Preliminary Clinical Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Hanyang University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Application of Rib Splint | Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects. |
Timeline
- Start date
- 2017-07-10
- Primary completion
- 2017-10-31
- Completion
- 2017-12-31
- First posted
- 2017-07-07
- Last updated
- 2017-07-07
Source: ClinicalTrials.gov record NCT03210792. Inclusion in this directory is not an endorsement.