Distal Radius Fracture
Conditions
Brief summary
Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are excellent medications for providing pain control in certain patients. There is some data to suggest that NSAIDs can be used to reduce postoperative pain and narcotic use in patients who had undergone carpal tunnel release. There are mixed results about the effect of bone healing in adult patients with broken bones. The investigators hypothesize that NSAID administration in the acute phase of distal radius fracture healing will be non-inferior for pain control and decrease the use of opioid analgesics compared to patients who take acetaminophen for pain control during this same time period. Furthermore, the investigators hypothesize that patients will have similar or better patient reported outcomes, range of motion, and strength with the administration of NSAIDs.
Detailed description
In the United States, drug overdose deaths and opioid-involved deaths continue to increase, quadrupling since 1999; six out of ten drug overdose deaths involve an opioid. Overdoses from prescription opioids are a driving factor in the 15-year increase in opioid overdose deaths. The amount of prescription opioids sold to pharmacies, hospitals, and doctors' offices has drastically risen, yet there had not been an overall change in the amount of pain that Americans reported. Deaths from prescription opioids-drugs like oxycodone, hydrocodone, and methadone-have more than quadrupled since 1999. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to control both postoperative pain and pain associated with some orthopaedic injuries in children and adults with certain orthopaedic injuries. Further, the use of NSAIDs for pain control has been shown to lessen the use of narcotic pain medications, the adverse effects of which are well known. With the current opioid epidemic, more research is needed to determine strategies to reduce opioid use in patients with orthopaedic injuries. Chapman et al. showed that NSAIDs can be used effectively to reduce postoperative pain and narcotic use in patients who had undergone carpal tunnel release. Although distal radius fractures are one of the most common fractures, no studies have examined the effect of NSAIDs on distal radius fracture pain. The purpose of this study is to compare pain and narcotic pain medication use in patients who have had distal radius fractures in patients who use NSAIDs to those who do not. To the authors' knowledge, there have been no clinical prospective, randomized studies to evaluate the effect that NSAIDs have on patients with distal radius fractures. The investigators hypothesize that NSAID administration in the acute phase of distal radius fracture healing will be non-inferior for pain control and decrease the use of opioid analgesics compared to patients who take acetaminophen for pain control during this same time period.
Interventions
DRUGIbuprofen
NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control
DRUGAcetaminophen
Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day.
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Distal radius fracture
Exclusion criteria
* Contraindication to NSAID use (ie, cannot tolerate, gastritis, ulcers, chronic kidney disease stage 4 or higher, bleeding disorders/thrombocytopenia) * Inability to take breakthrough medications * Regular use of NSAIDs * Regular use of Narcotics * Open fracture * Other orthopaedic injuries (polytrauma) * Pathologic fracture * Previous injury to the bone * Pregnant or plan to become pregnant * Unable to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oxycodone Tablets Used for Breakthrough Pain. | 2 weeks | The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded. |
| Intensity of Pain: Visual Analog Scale (VAS) | 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery | The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine. |
| Fractures Fully Healed | 6 weeks post surgery | Radiographic evidence of boney healing of the distal radius. This outcome measure is reported as the number of participants in each group with fully healed fractures at the designated time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Key Pinch Strength | 2 weeks, 6 weeks, and 3 months post surgery | Key pinch strength, also known as lateral pinch strength, measures the force exerted by the hand and fingers when pinching an object between the thumb and the radial side of the index finger. Normal ranges typically fall between 10 to 20 pounds of force (4.54 to 9.07 kgs). |
| QuickDASH | 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery | The QuickDASH is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb. |
| Wrist Range of Motion (ROM) | 2 weeks, 6 weeks and 3 months post surgery | Wrist ROM refers to the ability of the wrist to move in different directions. Normal wrist extension ranges from 70°- 90° resulting in a normal flexion-extension arc of 140-180°. The minimum wrist motion required for daily activities is 60° of extension, 54° of flexion, or approximately a 100° flexion-extension arc. ROM can be varied based on factors such as age, sex, and individual anatomy. |
| Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) | 2 Weeks, 6 Weeks, 3 Months, 6 Months and 1 Year post surgery | The PROMIS UE is scored using a T-score metric, where the mean of the general population is set to 50 with a standard deviation of 10. The minimum score on the PROMIS UE is 0, indicating the lowest level of upper extremity function, while the maximum score is 100, indicating the highest level of upper extremity function. Higher scores represent better upper extremity function. |
| Grip Strength | 2 Week, 6 Week and 3 Month Post Surgery | Grip strength refers to the force exerted by your hand muscles when you hold or squeeze something measured in kilograms. It's an essential measure of hand function and overall health. To assess grip strength, you can use a dynamometer-a device that measures the force applied during a handgrip. The test involves squeezing the dynamometer as hard as possible, typically with the elbow bent at a 90-degree angle. Grip strength varies based on factors such as age, sex and hand dominance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acetaminophen Acetaminophen will be given to participants for pain control following their injury.
Acetaminophen: Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day. | 14 |
| NSAID Ibuprofen will be given to participants for pain control following their injury.
Ibuprofen: NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control | 18 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Screen Failure | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Acetaminophen | NSAID | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 14 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 17 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 3 Participants | 8 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 18 |
| other Total, other adverse events | 0 / 14 | 0 / 18 |
| serious Total, serious adverse events | 0 / 14 | 0 / 18 |
Outcome results
Primary
Fractures Fully Healed
Radiographic evidence of boney healing of the distal radius. This outcome measure is reported as the number of participants in each group with fully healed fractures at the designated time point.
Time frame: 6 weeks post surgery
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acetaminophen | Fractures Fully Healed | 9 Participants |
| NSAID | Fractures Fully Healed | 9 Participants |
Primary
Intensity of Pain: Visual Analog Scale (VAS)
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
Time frame: 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team. A total of 14 participants in the Acetaminophen group, and a total of 18 participants in the NSAID group were analyzed through the various timepoints. Information was captured via a automated Electronic Data Capture program, which resulted in inconsistent follow-up at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen | Intensity of Pain: Visual Analog Scale (VAS) | 6 weeks postop | 1.0 score on a scale | Standard Deviation 1 |
| Acetaminophen | Intensity of Pain: Visual Analog Scale (VAS) | 6 months postop | 0.88 score on a scale | Standard Deviation 1.61 |
| Acetaminophen | Intensity of Pain: Visual Analog Scale (VAS) | 3 months postop | 0.75 score on a scale | Standard Deviation 1.75 |
| Acetaminophen | Intensity of Pain: Visual Analog Scale (VAS) | 1 year postop | 1.11 score on a scale | Standard Deviation 1.83 |
| Acetaminophen | Intensity of Pain: Visual Analog Scale (VAS) | 2 weeks postop | 2.46 score on a scale | Standard Deviation 2.07 |
| NSAID | Intensity of Pain: Visual Analog Scale (VAS) | 1 year postop | 1.66 score on a scale | Standard Deviation 2.91 |
| NSAID | Intensity of Pain: Visual Analog Scale (VAS) | 2 weeks postop | 2.05 score on a scale | Standard Deviation 2.82 |
| NSAID | Intensity of Pain: Visual Analog Scale (VAS) | 6 weeks postop | 1.25 score on a scale | Standard Deviation 1.75 |
| NSAID | Intensity of Pain: Visual Analog Scale (VAS) | 3 months postop | 1.88 score on a scale | Standard Deviation 2.08 |
| NSAID | Intensity of Pain: Visual Analog Scale (VAS) | 6 months postop | 2.55 score on a scale | Standard Deviation 3.12 |
Primary
Number of Oxycodone Tablets Used for Breakthrough Pain.
The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.
Time frame: 2 weeks
Population: Data were not collected due to 1.) incomplete medication diaries; and 2.) medication diaries not returned by participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen | Number of Oxycodone Tablets Used for Breakthrough Pain. | 16.71 oxycodone tablets | Standard Deviation 12.01 |
| NSAID | Number of Oxycodone Tablets Used for Breakthrough Pain. | 9.92 oxycodone tablets | Standard Deviation 11.98 |
Secondary
Grip Strength
Grip strength refers to the force exerted by your hand muscles when you hold or squeeze something measured in kilograms. It's an essential measure of hand function and overall health. To assess grip strength, you can use a dynamometer-a device that measures the force applied during a handgrip. The test involves squeezing the dynamometer as hard as possible, typically with the elbow bent at a 90-degree angle. Grip strength varies based on factors such as age, sex and hand dominance.
Time frame: 2 Week, 6 Week and 3 Month Post Surgery
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team. Grip Strength testing was not completed by all participants. Therefore, the number of participants who completed grip strength testing and were analyzed is listed as at these time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen | Grip Strength | 6 week postop | 12.6 kilograms | Standard Deviation 13.26 |
| Acetaminophen | Grip Strength | 3 month postop | 9.6 kilograms | Standard Deviation 5.73 |
| NSAID | Grip Strength | 2 week postop | 10.67 kilograms | Standard Deviation 9.54 |
| NSAID | Grip Strength | 3 month postop | 11.0 kilograms | Standard Deviation 8.25 |
| NSAID | Grip Strength | 6 week postop | 9.86 kilograms | Standard Deviation 8.49 |
Secondary
Key Pinch Strength
Key pinch strength, also known as lateral pinch strength, measures the force exerted by the hand and fingers when pinching an object between the thumb and the radial side of the index finger. Normal ranges typically fall between 10 to 20 pounds of force (4.54 to 9.07 kgs).
Time frame: 2 weeks, 6 weeks, and 3 months post surgery
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen | Key Pinch Strength | 6 week postop | 4.74 kilograms | Standard Deviation 3.22 |
| Acetaminophen | Key Pinch Strength | 3 month postop | 4.44 kilograms | Standard Deviation 2.18 |
| Acetaminophen | Key Pinch Strength | 2 week postop | 4.5 kilograms | Standard Deviation 3.11 |
| NSAID | Key Pinch Strength | 6 week postop | 5.56 kilograms | Standard Deviation 3.41 |
| NSAID | Key Pinch Strength | 3 month postop | 4.58 kilograms | Standard Deviation 1.68 |
| NSAID | Key Pinch Strength | 2 week postop | 3.25 kilograms | Standard Deviation 1.85 |
Secondary
Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity)
The PROMIS UE is scored using a T-score metric, where the mean of the general population is set to 50 with a standard deviation of 10. The minimum score on the PROMIS UE is 0, indicating the lowest level of upper extremity function, while the maximum score is 100, indicating the highest level of upper extremity function. Higher scores represent better upper extremity function.
Time frame: 2 Weeks, 6 Weeks, 3 Months, 6 Months and 1 Year post surgery
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team. At the 1-year postoperative mark, although 9 participants in each group followed up, the questionnaires were not completed by all participants. Therefore, the number of participants who completed the questionnaires and analyzed is listed as at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen | Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) | 6 week post | 34.86 score on a scale | Standard Deviation 11.12 |
| Acetaminophen | Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) | 3 month postop | 41.6 score on a scale | Standard Deviation 13.57 |
| Acetaminophen | Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) | 6 month postop | 42.3 score on a scale | Standard Deviation 0 |
| Acetaminophen | Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) | 2 week postop | 21.37 score on a scale | Standard Deviation 3.2 |
| NSAID | Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) | 2 week postop | 31.5 score on a scale | Standard Deviation 10.44 |
| NSAID | Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) | 6 month postop | 51.9 score on a scale | Standard Deviation 8.91 |
| NSAID | Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) | 6 week post | 40.81 score on a scale | Standard Deviation 11.9 |
| NSAID | Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) | 1 year postop | 58.2 score on a scale | Standard Deviation 0 |
| NSAID | Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity) | 3 month postop | 47.35 score on a scale | Standard Deviation 9.18 |
Secondary
QuickDASH
The QuickDASH is a subset of 11 items from the 30-item DASH and is a self-reported questionnaire in which the response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and the scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Time frame: 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team. At the 1-year postoperative mark, although 9 participants in each group followed up, the questionnaires were not completed. Therefore, the number analyzed is listed as '0' for both groups at this time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen | QuickDASH | 2 week postop | 34.54 score on a scale | Standard Deviation 11.74 |
| Acetaminophen | QuickDASH | 6 week postop | 42.61 score on a scale | Standard Deviation 9.92 |
| Acetaminophen | QuickDASH | 6 month postop | 43.18 score on a scale | Standard Deviation 0 |
| Acetaminophen | QuickDASH | 3 month postop | 47.16 score on a scale | Standard Deviation 2.18 |
| NSAID | QuickDASH | 3 month postop | 48.10 score on a scale | Standard Deviation 4.64 |
| NSAID | QuickDASH | 2 week postop | 43.18 score on a scale | Standard Deviation 6.76 |
| NSAID | QuickDASH | 6 month postop | 48.86 score on a scale | Standard Deviation 4.82 |
| NSAID | QuickDASH | 6 week postop | 47.22 score on a scale | Standard Deviation 5.3 |
Secondary
Wrist Range of Motion (ROM)
Wrist ROM refers to the ability of the wrist to move in different directions. Normal wrist extension ranges from 70°- 90° resulting in a normal flexion-extension arc of 140-180°. The minimum wrist motion required for daily activities is 60° of extension, 54° of flexion, or approximately a 100° flexion-extension arc. ROM can be varied based on factors such as age, sex, and individual anatomy.
Time frame: 2 weeks, 6 weeks and 3 months post surgery
Population: Due to attrition, the number analyzed at each time point is the number of participants who followed up with the research team
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acetaminophen | Wrist Range of Motion (ROM) | 2 weeks postop | 67.5 degrees | Standard Deviation 38.89 |
| Acetaminophen | Wrist Range of Motion (ROM) | 6 weeks postop | 89.38 degrees | Standard Deviation 57.53 |
| Acetaminophen | Wrist Range of Motion (ROM) | 3 months postop | 76.86 degrees | Standard Deviation 43.83 |
| NSAID | Wrist Range of Motion (ROM) | 2 weeks postop | 67.6 degrees | Standard Deviation 38.1 |
| NSAID | Wrist Range of Motion (ROM) | 6 weeks postop | 78.89 degrees | Standard Deviation 43.12 |
| NSAID | Wrist Range of Motion (ROM) | 3 months postop | 143.75 degrees | Standard Deviation 29.26 |