Rib FracturesNCT05080686
The Pain Control in Rib Fracture With Non-invasive Stabilization (RCT)
A study testing Posthorax Thoraxbelt in people with Rib Fractures and Pain, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
Brief summary: Background: Rib fractures are one of the most common causes of trauma disabilities and have become an important health issue. Patients usually suffer from severe pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rib Fractures, Pain, Thorax; Fracture
- What is being tested?
- Posthorax Thoraxbelt
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The adult patients with rib fractures (inpatients/outpatients)
- The patients will be assessed to the further admission (inpatients)
- The patients will be assessed to be at follow-up clinic visit (outpatients)
Who cannot join
- The accident of rib fractures has been occurred over 24 hours. (inpatients/outpatients)
- Refuse to be arranged to the admission (inpatients)
- Refuse to receive the CT scan (inpatients/outpatients)
- Chest wall infection or other diseases (inpatients/outpatients)
- Chest wall infected by rumors (inpatients/outpatients)
- Pregnancy (inpatients/outpatients)
- Further complications arise (inpatients/outpatients)
- Known allergy to ThoraxBelt (inpatients/outpatients)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, 300
Cheng-Yi Fan, MD, 0911438312, kpfzboekbof@gmail.com
About this study
Official title: The Management and Assessment of Pain Control in Rib Fracture With Non-invasive Stabilization: a Randomized Controlled Trial
Brief summary:
Background: Rib fractures are one of the most common causes of trauma disabilities and have become an important health issue. Patients usually suffer from severe pain. A rapid and adequate pain control is considered as a priority to improve respiratory mechanics and reduce the risk of pulmonary and systemic complications. So far, there was no gold standard regarding pain control for rib fractures.
Read more
Objective: To assess the effect of the newly-designed Prosthorax Thoraxbelt in addition to oral analgesics on pain control of rib fractures
Method: There will be two groups of patients in this study. One group will be the patients with rib fractures who are necessary for in-hospital intense pain control. The other will consist of follow-up patients with rib fractures at an outpatient clinic. The investigators will aim to recruit 30 and 82 patients respectively.
Read the detailed description
The study has been approved by the hospital research ethics committee.
Arm1: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (inpatients)
Arm2: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (outpatients)
Primary outcome:
- inpatient: Visual analog scale (VAS) for 6 hours, 12 hours and 24 hours after the surgery
- outpatient: Visual analog scale (VAS) for the times at emergency room; 3 days, 3 weeks and 3 months after rib fracture at an outpatient clinic.
Secondary outcome:
- inpatients
- The accumulated dose of the inter-venous patient-controlled analgesic drug within 6 hours, 24 hours and 48 hours after the surgery
- Complication during the hospital stay
- Hospital stay
- VAS before discharge
- Unanticipated events (ICU admission, a second surgery, death)
- VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery
- An X-ray examination at an outpatient clinic
- Compliance on ThoraxBelt after discharge
- outpatients
- Complication during the follow-up period
- Unanticipated events (ward admission, ICU admission, a surgery, OHCA)
- Compliance on ThoraxBelt after discharge
- An X-ray examination at an outpatient clinic
- Conditions
- Rib Fractures, Pain, Thorax; Fracture
- Being tested
- Posthorax Thoraxbelt
- Keywords
- Rib fractures, pain control, Posthorax Thoraxbelt
- Medical subject headings
- Rib Fractures, Pain, Fractures, Bone, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posthorax ThoraxbeltDevice
The patients will be assisted to put on the ThoraxBelt after surgery or at the emergency room by our research members and will be asked to keep it on except for showering through the whole study period.
| Study group | Role | What they receive |
|---|---|---|
| ThoraxBelt (Inpatients) | Experimental | Received ThoraxBelt after the surgery in addition to oral analgesics. Standard care for pain management will be the same as the Standard Care Arm (Inpatients). Receives: Device: Posthorax Thoraxbelt |
| Standard Care (Inpatients) | No intervention | Standard Care with IV PCA and on-request oral painkiller. |
| ThoraxBelt (Outpatients) | Experimental | Received ThoraxBelt at the emergency room in addition to oral analgesics. Standard care for pain management will be the same as the Standard Care Arm (Outpatients). Receives: Device: Posthorax Thoraxbelt |
| Standard Care (Outpatients) | No intervention | Standard Care and on-request oral painkiller. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inpatients: Visual analog scale (VAS)
A pain score will be assessed to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, from the least pain to the highest pain.
Measured: 48 hours
Outpatients: Visual analog scale (VAS)
A pain score will be assessed to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, from the l
Measured: 3 months
Secondary outcomes (11)
Inpatients: IV PCA dose
the accumulated IV PCA drug dose
Measured: 48 hours
Inpatients: On-request oral painkiller dose
the accumulated oral painkiller dose
Measured: 48 hours
Inpatients: Complication during the hospital stay
Any complications whether related to ThoraxBelt or not
Measured: 48 hours
Inpatients: Length of hospital stay
the amount of days in hospital stay
Measured: 1 month
Inpatients: VAS before discharge
Visual analog scale before discharge
Measured: 3 months
Inpatients: The amount of unanticipated events
send to the ICU admission, a second surgery or death
Measured: 3 months
Inpatients: VAS in outpatient clinic follow-up
VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery
Measured: 3 months
Inpatients/Outpatients: X-ray examination
An X-ray examination at an outpatient clinic
Measured: 3 months
Inpatients/Outpatients: Compliance on ThoraxBelt after discharge
How long is the ThroaxBelt removed except during the bath within the whole day. The unit is hour.
Measured: 3 months
Outpatients: Complication during the follow-up period
Any complications whether related to ThoraxBelt or not
Measured: 6 months
Outpatients: The amount of unanticipated events
send to the ward admission, ICU admission, a surgery or OHCA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080686
- Sponsor's protocol ID
- 110-079-F
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, we have no plan on sharing the IPD.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management and Assessment of Pain Control in Rib Fracture With Non-invasive Stabilization: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05080686
- Acronym / sponsor ID
- 110-079-F
- Conditions
- Rib Fractures, Pain, Thorax; Fracture
- Keywords
- Rib fractures, pain control, Posthorax Thoraxbelt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief summary:
Background: Rib fractures are one of the most common causes of trauma disabilities and have become an important health issue. Patients usually suffer from severe pain. A rapid and adequate pain control is considered as a priority to improve respiratory mechanics and reduce the risk of pulmonary and systemic complications. So far, there was no gold standard regarding pain control for rib fractures.
Objective: To assess the effect of the newly-designed Prosthorax Thoraxbelt in addition to oral analgesics on pain control of rib fractures
Method: There will be two groups of patients in this study. One group will be the patients with rib fractures who are necessary for in-hospital intense pain control. The other will consist of follow-up patients with rib fractures at an outpatient clinic. The investigators will aim to recruit 30 and 82 patients respectively.
Detailed description
The study has been approved by the hospital research ethics committee.
Arm1: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (inpatients)
Arm2: The management and assessment of pain control in rib fracture with non-invasive stabilization: a randomized controlled trial (outpatients)
Primary outcome:
- inpatient: Visual analog scale (VAS) for 6 hours, 12 hours and 24 hours after the surgery
- outpatient: Visual analog scale (VAS) for the times at emergency room; 3 days, 3 weeks and 3 months after rib fracture at an outpatient clinic.
Secondary outcome:
- inpatients
- The accumulated dose of the inter-venous patient-controlled analgesic drug within 6 hours, 24 hours and 48 hours after the surgery
- Complication during the hospital stay
- Hospital stay
- VAS before discharge
- Unanticipated events (ICU admission, a second surgery, death)
- VAS during the 1-week, 1-month and 3-month outpatient clinic visit after the surgery
- An X-ray examination at an outpatient clinic
- Compliance on ThoraxBelt after discharge
- outpatients
- Complication during the follow-up period
- Unanticipated events (ward admission, ICU admission, a surgery, OHCA)
- Compliance on ThoraxBelt after discharge
- An X-ray examination at an outpatient clinic
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ThoraxBelt (Inpatients) | Experimental | Device: Posthorax ThoraxbeltReceived ThoraxBelt after the surgery in addition to oral analgesics. Standard care for pain management will be the same as the Standard Care Arm (Inpatients). |
| Standard Care (Inpatients) | No intervention | –Standard Care with IV PCA and on-request oral painkiller. |
| ThoraxBelt (Outpatients) | Experimental | Device: Posthorax ThoraxbeltReceived ThoraxBelt at the emergency room in addition to oral analgesics. Standard care for pain management will be the same as the Standard Care Arm (Outpatients). |
| Standard Care (Outpatients) | No intervention | –Standard Care and on-request oral painkiller. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The adult patients with rib fractures (inpatients/outpatients)
- The patients will be assessed to the further admission (inpatients)
- The patients will be assessed to be at follow-up clinic visit (outpatients)
Key exclusion criteria (8 listed)
- The accident of rib fractures has been occurred over 24 hours. (inpatients/outpatients)
- Refuse to be arranged to the admission (inpatients)
- Refuse to receive the CT scan (inpatients/outpatients)
- Chest wall infection or other diseases (inpatients/outpatients)
- Chest wall infected by rumors (inpatients/outpatients)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posthorax ThoraxbeltThe patients will be assisted to put on the ThoraxBelt after surgery or at the emergency room by our research members and will be asked to keep it on except for showering through the whole study period. | Device | ThoraxBelt (Inpatients), ThoraxBelt (Outpatients) |
Primary outcome
Inpatients: Visual analog scale (VAS)
Time frame: 48 hours
A pain score will be assessed to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, from the least pain to the highest pain.
Outpatients: Visual analog scale (VAS)
Time frame: 3 months
A pain score will be assessed to each patient after the total amount of visual analog scale. The minimum is 0 and the maximum is 10, from the l
11 secondary outcomes
Inpatients: IV PCA dose
Time frame: 48 hours
Inpatients: On-request oral painkiller dose
Time frame: 48 hours
Inpatients: Complication during the hospital stay
Time frame: 48 hours
Inpatients: Length of hospital stay
Time frame: 1 month
Inpatients: VAS before discharge
Time frame: 3 months
Inpatients: The amount of unanticipated events
Time frame: 3 months
Inpatients: VAS in outpatient clinic follow-up
Time frame: 3 months
Inpatients/Outpatients: X-ray examination
Time frame: 3 months
Inpatients/Outpatients: Compliance on ThoraxBelt after discharge
Time frame: 3 months
Outpatients: Complication during the follow-up period
Time frame: 6 months
Outpatients: The amount of unanticipated events
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No. Currently, we have no plan on sharing the IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posthorax Thoraxbelt in people with Rib Fractures and Pain, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Yi Fan, M.D. (+886911438312, chengyi.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inpatients: Visual analog scale (VAS) (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.