Distal Radius FracturePhase 4Adult NSAIDNCT03749616
Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture
A Phase 4 study testing Ibuprofen and Acetaminophen in people with Distal Radius Fracture, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Ibuprofen and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 24 Mar 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Distal radius fracture
Who cannot join
- 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)
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- Pathologic fracture
- Previous injury to the bone
- Pregnant or plan to become pregnant
- Unable to sign informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Health Care
Columbia, Missouri, 65212
About this study
Official title: Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study
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.
Read the 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.
- Conditions
- Distal Radius Fracture
- Being tested
- Ibuprofen, Acetaminophen
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Motrin, Advil
NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control
AcetaminophenDrug
Also called tylenol
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.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Active comparator | 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.
Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain. Receives: Drug: Acetaminophen |
| NSAID | Experimental | NSAID administered ibuprofen 400-800 mg, up to three times a day and acetaminophen with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day as needed for pain control.
Oxycodone 5mg 1-2 tablets q4-6 hours will be available for breakthrough pain. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oxycodone Tablets Used for Breakthrough Pain.
The number and dosing of oxycodone tablets taken per participant for breakthrough pain will be recorded.
Measured: 2 weeks
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.
Measured: 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery
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.
Measured: 6 weeks post surgery
Secondary outcomes (5)
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.
Measured: 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery
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.
Measured: 2 Weeks, 6 Weeks, 3 Months, 6 Months and 1 Year post surgery
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.
Measured: 2 Week, 6 Week and 3 Month Post Surgery
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).
Measured: 2 weeks, 6 weeks, and 3 months post surgery
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.
Measured: 2 weeks, 6 weeks and 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start2 Jan 2019
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Why it stopped: Original principal investigator left the institution and investigator replacing him did not have the patient population to enroll as needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel London, University of Missouri-Columbia
- Investigators
- Daniel A London, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749616
- Sponsor's protocol ID
- 2009129
- Acronym
- Adult NSAID
- Status last verified
- Aug 2024
- First submitted
- 26 Sep 2018
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT03749616
- Acronym / sponsor ID
- Adult NSAID / 2009129
- Conditions
- Distal Radius Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original principal investigator left the institution and investigator replacing him did not have the patient population to enroll as needed.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Active comparator | Drug: AcetaminophenAcetaminophen 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. Oxycodone 5mg 1-2 tablets q4-6 hours will be available as needed for breakthrough pain. |
| NSAID | Experimental | Drug: IbuprofenNSAID administered ibuprofen 400-800 mg, up to three times a day and acetaminophen with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day as needed for pain control. Oxycodone 5mg 1-2 tablets q4-6 hours will be available for breakthrough pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- Distal radius fracture
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| IbuprofenAlso: Motrin, AdvilNSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control | Drug | NSAID |
| AcetaminophenAlso: tylenolControl 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. | Drug | Acetaminophen |
Primary outcome
Number of Oxycodone Tablets Used for Breakthrough Pain.
Time frame: 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)
Time frame: 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
Time frame: 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.
5 secondary outcomes
QuickDASH
Time frame: 2 Week, 6 Week, 3 Month, 6 Month and 1 Year Post Surgery
Patient Reported Outcomes Measurement Information System (PROMIS) - UE (Upper Extremity)
Time frame: 2 Weeks, 6 Weeks, 3 Months, 6 Months and 1 Year post surgery
Grip Strength
Time frame: 2 Week, 6 Week and 3 Month Post Surgery
Key Pinch Strength
Time frame: 2 weeks, 6 weeks, and 3 months post surgery
Wrist Range of Motion (ROM)
Time frame: 2 weeks, 6 weeks and 3 months post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Daniel A London, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen and Acetaminophen in people with Distal Radius Fracture, run by University of Missouri-Columbia at 1 site in United States.
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 2 inclusion and 10 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: stopped early, as of the sponsor's last update on 5 Sep 2024. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Oxycodone Tablets Used for Breakthrough Pain. (time frame: 2 weeks). The study lists 3 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 5 Sep 2024.