Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function
Orthosis of Acute Traumatic Rib Fractures Via RibFx Belt for Pain Alleviation and Improved Pulmonary Function
Acute traumatic rib fractures are a common issue for patients of trauma surgeons. They
 inflict substantial morbidity, the most dreaded and consequential of which are pulmonary
 complications. While these fractures are often treated non-operatively, there is a continued
 need for effective adjuvant treatments to improve rib fracture pain and outcomes. Prior
 studies have evaluated outcome measures for traumatic rib fractures that include respiratory
 failure, tracheostomy requirement, ICU length of stay, hospital length of stay, narcotic
 requirement, daily maximum incentive spirometry volume, pneumonia, and mortality .

 Rib belts, which have been present since at least 1945, have long been used to provide pain
 relief via chest wall stabilization [3]. However there is an extreme paucity of literature
 regarding their clinical efficacy, and their use has largely been abandoned due to concerns
 that they may have been overly constricting and resulted in poorer respiratory
 (pulmonary/breathing) outcomes. Newer generation rib belts are more elastic and theoretically
 less constricting than their earlier generation predecessors, however their clinical efficacy
 has not been yet demonstrated. The investigators will therefore plan to perform a prospective
 trial to determine if these rib strapping devices are effective clinical tools in the
 traumatic rib fracture population. The goal of the study is institutional quality
 improvement, to determine if the investigators see benefit of these devices for the pain
 management of our trauma population. The investigators will also conduct this as a pilot
 trial for hopeful future research applications, however the overall goal is institutional
 improvement.

 Patients determined to be eligible for the study by the admitting physician (and per the
 previously defined criteria) will be recruited to enroll in the project within the first 24
 hours of their hospital admission. Recruited patients will be offered the opportunity to
 consent to enrollment in the study and will be assigned by the study team into either the
 intervention (RibFx belt +current standard of care) or control (current standard of care) arm
 in a quasi-experimental prospective design: untreated control group with dependent pretest
 and posttest samples. In this manner, the intervention arm will be both compared to
 themselves (pretest vs. posttests) as well as to a control group not exposed to the
 intervention.

 The relevant study materials will be included in their paper (physical) and electronic chart.
 Patients upon enrollment in the study will undergo an initial assessment that will include
 their baseline pain scores, narcotic consumption, incentive spirometry scores, and the
 subjective self-reported results of their questionnaire (the pre-test questionnaire- see
 attached). Patients will continue to be scored on objective (incentive spirometry results,
 opioid pain medicine consumption) and subjective variables (pain scores) during their
 hospital course. Between 24-48 hours after enrollment, they will be prompted to again
 complete a similar 2nd questionnaire post-test (if they are discharged from the hospital at
 this point in the time course, they will be sent home with the questionnaire and prompted to
 complete it at home). At their follow up appointment in trauma clinic (which will be
 coordinated by the research team to be as close as possible to 3 weeks post injury), they
 will have the opportunity to again voluntarily complete a final short questionnaires
 (post-test) that assess their pain control and respiratory function over the last 3 weeks. At
 this point, their involvement in the trial will be complete.

 Patients themselves will play an active role in data collection during the trial, and will be
 instructed and prompted in how to do so. Patients will be expected to fill out a worksheet on
 a daily basis, both while inpatient and after discharge, on their daily incentive spirometry
 scores as well as their minimum and maximum pain scale scores. This will be used to
 supplement the survey or questionnaire data, as well as the objective data from the
 electronic medical record.

 The investigators will ultimately compare groups using a quasi-experimental design as
 follows: Untreated control group with dependent pretest and posttest samples. This will allow
 for a direct comparison of patient to patient within the intervention arm (patient pretest
 result serving as control compared to posttest result) . To observe for temporal variability,
 their will be a control group with no intervention as well (no rib belt worn) , however the
 principle aim of the study is the comparison of patients to themselves in a pre-test,
 post-test fashion.
The purpose of this study is to ascertain whether the use of next generation rib orthosis
 belts (such as the RibFx) can improve patient outcomes following traumatic rib fractures
 within our population, whether it be by improving pain control, decreased respiratory
 complications, or increased patient satisfaction. The investigators hypothesize that the use
 of elastic rib belts will improve rib fracture pain control without compromising pulmonary
 function (statistically significant improvement in pain control without significant
 impairment in respiratory function or increase in respiratory complication). The
 investigators feel as though answering this question can help us as providers to improve the
 quality of care to our patients in our department.

 Rib fractures are a common traumatic injury, and can cause substantial morbidity and
 mortality in the trauma population. As rib fractures most often are not treated with surgical
 intervention, there is demand for non-operative strategies to promote healing, pain control,
 and mechanical/musculoskeletal support. This can also help decrease the administration of
 potentially harmful pain medications such as opioid or narcotic pain medication. Further, as
 rib fracture pain can often be long lasting, this can truly increase quality of life for
 patients as they recover from these injuries.

 The objectives of the clinical trial are to determine if rib orthosis via the use of the
 RibFx belt can improve patients after traumatic rib fractures by improving pain control
 without compromise of respiratory function or increase respiratory complications of rib
 fracture.

 Per Jeffords Institute for Quality Data of the University of Vermont, there were 190 patients
 admitted the to Acute Care Surgery (Trauma) service at the University of Vermont Medical
 Center during the year 2016. Assuming that these numbers remain fairly static overtime as
 they have in the past, the investigators would expect approximately 16 patient admissions per
 month with the diagnosis of rib fracture (seasonal fluctuations do exist with more traumatic
 admissions during the summer months). The goal time period for the trial would be to conduct
 this trial during the summer, with a goal of 50 total patients. The investigators would
 therefore expect an enrollment period (data collection phase) of approximately 3 months.

 During the study, appropriate patients will be recruited both to the control arm of the study
 and the intervention/comparison arm in a specified / non-randomized sequence as seen in the
 schematic below (First 5 patients control, next five patients intervention, next five
 patients control, next five patients intervention, next five patients control, final 25
 patients intervention). Control arm will include 15 total patients. All will be consented to
 the study upon admission (first 24 hours of index hospitalization for injury) with full
 knowledge that they will either be undergoing no intervention other than receiving the
 current standard of care for rib fracture care per our institution's standard, and if
 assigned to the rib belt group, expected to wear the rib belt during their recovery.

 The current standard of care for rib fractures at our 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).

 All patients will undergo initial "Pre-test" testing which will include baseline pain scores
 (1-10 traditional pain scale assessed every 8 hours, then averaged over the 24 hour period),
 initial narcotic consumption (in MME) for first 24 hours of hospitalization, maximum
 incentive spirometry score for first 24 hours of hospitalization, and pre-test questionnaire
 result (see attached questionnaire #1). As the study continues their relevant data will be
 collected, including both objective (incentive spirometry scores, opioid pain medication
 consumption, incidence of atelectasis and pneumonia) and subjective (pain scores, survey
 result) clinical data. Concurrently, The investigators will complete the trial with the
 intervention (RibFx belt) phase in which participants will be enrolled in the interventional
 arm of the study. The objective and subjective data will be collected in an identical
 fashion- the only difference between groups will be that this group will have been fitted
 with the RibFx belt for their hospital course and discharge.

 The participants (both in the control and interventional groups) will again be asked to
 complete essentially the same brief surveys in a post-test fashion at two set time points:
 between 24-48 hours after initial enrollment in the study (Questionnaire #2)(if patient has
 been discharged at this point, they will be sent home with this survey and instructed when to
 complete), and at 3 weeks post-injury (this will be done at their clinic visit, assuming they
 are not still admitted to the hospital at this time point).

 Patients will also be sent home with a work-book to record their incentive spirometry scores
 and pain scores (all patients will be sent home with an incentive spirometer, and all
 patients in the interventional group will be sent home with their Ribfx belt).

 The following additional data will also be quantified from the medical record via manual data
 extraction: ICU length of stay, hospital length of stay, pulse oximetry and respiratory rate
 scores (taken from already collected vital signs every four hours), body mass index (BMI),
 bronchodilator (such as albuterol or other inhaled beta agonist) use, age, sex/gender,
 tobacco history/pack years, days on mechanical ventilator, narcotic requirement (in mean
 morphine equivalents or morphine equianalgesic dose per day).

 In addition, an independent radiology physician will analyze the chest x-rays, CT chests of
 the patients enrolled in the study and grade them in a blinded fashion) on a scale for the
 following characteristics: Degree and quantity of rib fracture, presence and degree of
 atelectasis, presence of COPD/emphysematous change or other parenchymal lung disease,
 presence and degree of pneumothorax, bilateral vs. unilateral disease, presence of
 intrapleural fluid, evidence of "flail chest" segment, and presence of pulmonary contusion
 and other noted pathology (see the attached Radiology Grading Form document). The
 investigators will measure the degree of radiological severity and compare the control and
 interventional group to determine what differences in initial disease severity exist (so they
 can be accounted for).

 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.

 Patients will be assessed with three short questionnaires in a pretest , posttest fashion at
 both the onset of the study, 24-48 hours after enrollment, and at their follow-up appointment
 3 weeks after (2 post test questionnaires). The initial evaluation will occur on initial
 assessment prior to placement of the rib belt (or, for the control/ non-intervention group,
 at the onset/first 24 hours of the study).

 Each of the questionnaires is essentially the same with only brief modifications made in the
 first two questions to make them appropriate for the timing during the clinical course.
 However these are all attached (see Questionnaire 1,2,and 3).

 Patients in both the intervention and control arms will present in post-admission follow up
 at a time period of 3 weeks post injury (range, 2-4 weeks) following their hospital
 admission, and will be asked to fill out a brief survey regarding their respiratory function
 and pain control. This survey will also inquire into compliance with the use of incentive
 spirometer, and compliance with the use of the RibFx belt (for patients in the intervention
 arm).

 The surveys are a novel series of questionnaires using previously validated tools such as the
 COPD Assessment Test or CAT (Jones PW, Harding G, Berry P et al 2009) and the Brief Pain
 Inventory (BPI) in order to subjectively assess each patient's own breathing/ respiratory and
 pain symptoms. The surveys also have additional questions gaging their pain medication usage,
 compliance with their treatment therapies (including IS and rib belt usage, when applicable).
 The survey is designed to be completed in ten minutes. The survey was constructed with the
 assistance of a professor psychologist who specializes survey construction (Author ACB).
 There will be no financial compensation for survey completions.

 All surveys will be adapted to apply to the unique population being surveyed- the post-trauma
 population. This may involve removal of some questions that are not applicable to the rib
 fracture patients. There are several questions on the questionnaire that might not be
 applicable to the control group- they are simply instructed to not complete those four
 questions.

 The surveys have been modified in order to be more easily comprehended to the average
 patient, and to require minimal additional instruction (so that the patient can complete them
 independently with no additional prompting).

 In this study, The investigators will utilize a quasi-experimental design to compare 35
 subjects to themselves in a pre-test, post-test fashion. In addition, the investigators will
 have an additional 15 non-interventional control patients to observe for temporal changes in
 patient's symptoms not secondary to the intervention itself. However, it is important to note
 that the study is not powered to detect differences between the control group and the
 intervention group. The purpose of the control group is to observe for differences that occur
 in this population over time regardless of intervention (it should be assumed that pain will
 improve as time increases from the set injury point, regardless of intervention). Further,
 this preliminary data could potentially be used to calculate an accurate power calculation
 for a definitive randomized controlled trial.

 Groups will be compared by demographical and clinical data to determine what potentially
 confounding differences exist between the arms of the study. Relevant objective data that
 will be used to determine group differences include (but not limited to): age, sex, tobacco
 use status (active/former/none), presence of asthma, presence of COPD, or presence of
 restrictive lung disease, home oxygen use, obstructive sleep apnea/ CPAP use, chronic pain
 incidence, narcotic/opioid medication consumption, obesity/ BMI. The investigators will also
 measure relevant variables of their clinical course such as regional
 block/anesthesia/epidural administration. Radiological appearance of presenting imaging
 (either CT Chest or chest X-ray) will be compared by a dedicated and blinded radiologist who
 will grade the initial imaging based on severity including the following variables: number of
 fractures, bilateral vs. unilateral, degree of displacement, presence of lung contusion,
 presence of pneumothorax, presence of intrinsic lung disease, pleural effusion or blood.

 Survey results (both pretest and posttests) will be compared using the appropriate
 statistical methods depending on the questions construct: with Chi squared performed for
 categorical variables (such as multiple choice) and unpaired t test for continuous variables
 (such as likert scale rankings).

 The investigators have performed a power calculation to determine if the following hypothesis
 can be reasonably answered with the trial of this size: the investigators hypothesize that
 the RibFx belt can improve pain control in the post-rib fracture setting for patients without
 impeding pulmonary functioning. The investigators anticipate seeing an improvement in pain
 scores and/or narcotic consumption within the rib belt group, without seeing significant
 differences in pulmonary function (although do expect a nonsignfiicant trend toward improved
 pulmonary function).

 In order to perform our power function the investigators reviewed the literature to determine
 prior similar samples to our expected cohort. The investigators performed our power
 calculation with the goal of 80% power (with 2-sided alpha= 0.05). The investigators
 anticipate based on prior studies (Fabricant et al that the baseline chest wall pain score
 (MPQ PPI and MPQ PRI) were a median of 3 (range 0-5) and a mean of 28 +/- 16 (range 0-70)
 respectively1. Looking at a study for Bugaev et al, the investigators can also anticipate
 pain medicine requirements in the form of Mean Equianalgesic Dose (MED) of opioid pain
 medication. In this study, the MED for rib fracture patients was found to be 135.8 (IQR
 50.83-440.0). Finally, Butts CA et al 3 studied incentive spirometry volume (ISV) scores in
 this population of patients and found their median ISV (in ml) was 1250 (IQR 750-1250).

 For a one-group pre-post design, a sample size of 30 subjects would provide 83% power to
 detect a 20% decrease in MPQ PRI, assuming a within subject correlation of 0.8 for MPQ PRI
 scores and using a two-sided type I error rate of 0.05. A sample size of 35 (the planned size
 of the intervention group), provides an 88% power to detect a 20% decrease.
Inclusion Criteria:

 -  Adult person age 18-80 admitted with at least one acute traumatic closed rib fracture
 to the University of Vermont Medical Center

 Exclusion Criteria:

 -  Pediatric (<18 year old) and Geriatric (>80 year old) patients

 -  Patients who are intubated on arrival or within first 24 hours of admission or with
 Glasgow Coma Scale (GCS) < 14 (altered or depressed consciousness)

 -  Pregnant patients

 -  Patients who undergo operative rib fixation for their rib fractures (such as open
 reduction internal fixation, or rib plating)

 -  Patients with chest wall deformity, lacerations, burns, or soft tissue injuries that
 preclude placement of the RibFx belt

 -  Patients with an additional mechanism of injury that would create severe distracting
 pain, as determine by the admitting team.

 -  Isolated 1st rib or 2nd rib fractures