Trial Outcomes & Findings for Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function (NCT NCT03846024)

Results Overview

Compare pain control in patients with non-operatively managed traumatic rib fractures via subjective/qualitative self-reporting of pain control via questionnaires Pain control will be predominantly measured utilizing a likert scale score of 1 to 10, with a score of 1 denoting the lowest amount of pain and a score of 10 indicating the highest amount of pain. This will assist us in comparing patient pain scores in an objective manner.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

Inpatient Stay

Results posted on

2023-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	RibFx Belt Arm Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated. RibFx Orthosis Belt: Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.	Control Patients in the control arm receive normal standard of care for rib fractures at the participating institution. The current standard of care for rib fractures at the University of Vermont (participating institution) is as follows: includes oral and IV analgesia and other multimodal pain control as appropriate, including muscle relaxants such as methocarbamol (robaxin) unless there is a contraindication, pulmonary hygiene/toilet and respiratory care (including frequent evaluations by physicians, respiratory therapists, and nursing staff, early mobilization, and monitoring for pulmonary complication (via vital signs, pulse oximetry, oxygen requirement, chest imaging if appropriate).
Overall Study STARTED	12	15
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RibFx Belt Arm n=12 Participants Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated. RibFx Orthosis Belt: Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.	Control n=15 Participants Patients in the control arm receive normal standard of care for rib fractures at the participating institution. The current standard of care for rib fractures at the University of Vermont (participating institution) is as follows: includes oral and IV analgesia and other multimodal pain control as appropriate, including muscle relaxants such as methocarbamol (robaxin) unless there is a contraindication, pulmonary hygiene/toilet and respiratory care (including frequent evaluations by physicians, respiratory therapists, and nursing staff, early mobilization, and monitoring for pulmonary complication (via vital signs, pulse oximetry, oxygen requirement, chest imaging if appropriate).	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=15 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=12 Participants	7 Participants n=15 Participants	14 Participants n=27 Participants
Age, Categorical >=65 years	5 Participants n=12 Participants	8 Participants n=15 Participants	13 Participants n=27 Participants
Sex: Female, Male Female	3 Participants n=12 Participants	2 Participants n=15 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	9 Participants n=12 Participants	13 Participants n=15 Participants	22 Participants n=27 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	15 participants n=15 Participants	27 participants n=27 Participants

PRIMARY outcome

Timeframe: Inpatient Stay

Population: Population described includes participants where data was collected regarding pain control during their inpatient stay (1 patient withdrawn prior to data collection).

Compare pain control in patients with non-operatively managed traumatic rib fractures via subjective/qualitative self-reporting of pain control via questionnaires Pain control will be predominantly measured utilizing a likert scale score of 1 to 10, with a score of 1 denoting the lowest amount of pain and a score of 10 indicating the highest amount of pain. This will assist us in comparing patient pain scores in an objective manner.

Outcome measures

Outcome measures
Measure	RibFx Belt Arm n=12 Participants Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated. RibFx Orthosis Belt: Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.	Control n=14 Participants Patients in the control arm receive normal standard of care for rib fractures at the participating institution. The current standard of care for rib fractures at the University of Vermont (participating institution) is as follows: includes oral and IV analgesia and other multimodal pain control as appropriate, including muscle relaxants such as methocarbamol (robaxin) unless there is a contraindication, pulmonary hygiene/toilet and respiratory care (including frequent evaluations by physicians, respiratory therapists, and nursing staff, early mobilization, and monitoring for pulmonary complication (via vital signs, pulse oximetry, oxygen requirement, chest imaging if appropriate).
Rib Fracture Subjective Self-Reported Pain (Inpatient)	5.96 score on a scale Standard Deviation 2.59	5.40 score on a scale Standard Deviation 1.85

PRIMARY outcome

Timeframe: Inpatient Stay

Population: Population described includes participants where data was collected during inpatient stay (1 patient withdrawn prior to data collection).

Count of participants who required any use of a prescribed pain medication at any point throughout their inpatient stay.

Outcome measures

Outcome measures
Measure	RibFx Belt Arm n=12 Participants Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated. RibFx Orthosis Belt: Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.	Control n=14 Participants Patients in the control arm receive normal standard of care for rib fractures at the participating institution. The current standard of care for rib fractures at the University of Vermont (participating institution) is as follows: includes oral and IV analgesia and other multimodal pain control as appropriate, including muscle relaxants such as methocarbamol (robaxin) unless there is a contraindication, pulmonary hygiene/toilet and respiratory care (including frequent evaluations by physicians, respiratory therapists, and nursing staff, early mobilization, and monitoring for pulmonary complication (via vital signs, pulse oximetry, oxygen requirement, chest imaging if appropriate).
Narcotic/ Opioid Pain Medication Requirement After Rib Fracture (Inpatient)	12 Participants	14 Participants

PRIMARY outcome

Timeframe: 4 Week Follow Up

Population: Population analyzed limited to those participants whose data was acquired through administration of the questionnaire at their 4 week follow up appointment.

Count of participants who required any use of a prescribed pain medication at any point between their discharge from the hospital and their follow up appointment at 4 weeks.

Outcome measures

Outcome measures
Measure	RibFx Belt Arm n=6 Participants Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated. RibFx Orthosis Belt: Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.	Control n=10 Participants Patients in the control arm receive normal standard of care for rib fractures at the participating institution. The current standard of care for rib fractures at the University of Vermont (participating institution) is as follows: includes oral and IV analgesia and other multimodal pain control as appropriate, including muscle relaxants such as methocarbamol (robaxin) unless there is a contraindication, pulmonary hygiene/toilet and respiratory care (including frequent evaluations by physicians, respiratory therapists, and nursing staff, early mobilization, and monitoring for pulmonary complication (via vital signs, pulse oximetry, oxygen requirement, chest imaging if appropriate).
Narcotic/ Opioid Pain Medication Requirement After Rib Fracture (Home)	3 Participants	3 Participants

PRIMARY outcome

Timeframe: 4 Week Follow Up

Population: Population analyzed limited to those participants whose data was acquired through completion of the follow up questionnaire at 4 weeks.

Compare pain control in patients with non-operatively managed traumatic rib fractures via subjective/qualitative self-reporting of pain control via questionnaires Pain control will be predominantly measured utilizing a likert scale score of 1 to 10, with a score of 1 denoting the lowest amount of pain and a score of 10 indicating the highest amount of pain. This will assist us in comparing patient pain scores in an objective manner.

Outcome measures

Outcome measures
Measure	RibFx Belt Arm n=6 Participants Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated. RibFx Orthosis Belt: Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.	Control n=10 Participants Patients in the control arm receive normal standard of care for rib fractures at the participating institution. The current standard of care for rib fractures at the University of Vermont (participating institution) is as follows: includes oral and IV analgesia and other multimodal pain control as appropriate, including muscle relaxants such as methocarbamol (robaxin) unless there is a contraindication, pulmonary hygiene/toilet and respiratory care (including frequent evaluations by physicians, respiratory therapists, and nursing staff, early mobilization, and monitoring for pulmonary complication (via vital signs, pulse oximetry, oxygen requirement, chest imaging if appropriate).
Rib Fracture Subjective Self-Reported Pain (Home)	3.33 score on a scale Standard Deviation 2.80	3.30 score on a scale Standard Deviation 1.89

SECONDARY outcome

Timeframe: Inpatient Stay

Population: Population described includes participants where data was collected during inpatient stay (1 patient withdrawn prior to data collection).

Compare pulmonary hygiene and function amongst patients with non-operatively managed traumatic rib fractures via incentive spirometry scores. Incentive spirometry will be used as a tool to measure and compare patient pulmonary hygiene. The incentive spirometer at the participating institution are scaled to permit quantifiable deep breathing from 0 to 2500 mL (or cc).

Outcome measures

Outcome measures
Measure	RibFx Belt Arm n=12 Participants Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated. RibFx Orthosis Belt: Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.	Control n=14 Participants Patients in the control arm receive normal standard of care for rib fractures at the participating institution. The current standard of care for rib fractures at the University of Vermont (participating institution) is as follows: includes oral and IV analgesia and other multimodal pain control as appropriate, including muscle relaxants such as methocarbamol (robaxin) unless there is a contraindication, pulmonary hygiene/toilet and respiratory care (including frequent evaluations by physicians, respiratory therapists, and nursing staff, early mobilization, and monitoring for pulmonary complication (via vital signs, pulse oximetry, oxygen requirement, chest imaging if appropriate).
Incentive Spirometry Score (Inpatient)	1677.99 mL Standard Deviation 688.55	1738.93 mL Standard Deviation 575.38

SECONDARY outcome

Timeframe: 4 Week Follow Up

Population: Data not collected before study termination.

As measured by clinical diagnosis of pneumonia following rib fracture, either documented in physician note or added to problem list

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 Week Follow Up

Population: Data not collected before study termination.

As measured by a participating blinded radiologist in any images obtained following the rib fractures

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 Week Follow Up

Population: Population analyzed limited to those participants whose data was acquired through collection of home diary.

Compare pulmonary hygiene and function amongst patients with non-operatively managed traumatic rib fractures via incentive spirometry scores. Incentive spirometry will be used as a tool to measure and compare patient pulmonary hygiene. The incentive spirometer at the participating institution are scaled to permit quantifiable deep breathing from 0 to 2500 mL (or cc).

Outcome measures

Outcome measures
Measure	RibFx Belt Arm n=2 Participants Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated. RibFx Orthosis Belt: Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.	Control n=5 Participants Patients in the control arm receive normal standard of care for rib fractures at the participating institution. The current standard of care for rib fractures at the University of Vermont (participating institution) is as follows: includes oral and IV analgesia and other multimodal pain control as appropriate, including muscle relaxants such as methocarbamol (robaxin) unless there is a contraindication, pulmonary hygiene/toilet and respiratory care (including frequent evaluations by physicians, respiratory therapists, and nursing staff, early mobilization, and monitoring for pulmonary complication (via vital signs, pulse oximetry, oxygen requirement, chest imaging if appropriate).
Incentive Spirometry Score (Home)	1693.75 mL Standard Deviation 492.03	2028.75 mL Standard Deviation 501.28

Adverse Events

RibFx Belt Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ethan Jones

University of Vermont

Phone: 802-656-9437

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place