NSAID Use and Healing After Tibia Fractures and Achilles Tendon Ruptures
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|ClinicalTrials.gov Identifier: NCT03880981|
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Rationale: The Emergency Department (ED) typically serves as the front line for patients with acute fractures and tendon ruptures. Pain control for these patients is an essential task of the ED physician. With the advent of the opioid epidemic, ED physicians are becoming more inclined to prescribe non-narcotic pain medications such as non-steroidal anti-inflammatory drugs (NSAIDs). Yet, the effects of NSAIDs on musculoskeletal healing are controversial. The few human studies examining the effects of NSAID use on fracture healing have provided conflicting results. Even less is known about the effects of NSAIDs on tendon healing as this information has largely been gleaned from rodent studies with contradictory findings. There has never been a large, prospective, randomized, double-blinded study to determine the effects of NSAIDs on healing after fractures or tendon ruptures. Here, I propose to pilot the first prospective, randomized, double-blinded study examining the effects of NSAID use on healing after tibia fractures and Achilles tendon ruptures.
Aim 1 seeks to determine whether NSAID use is associated with an increased incidence of fracture nonunion and worse functional recovery six months following tibia fractures. I hypothesize that NSAID use after tibia fractures will be associated with an increased incidence of fracture nonunion and worse functional recovery. Aim 2 seeks to determine whether NSAID use is associated with worse functional recovery six months after Achilles tendon ruptures. I hypothesize that NSAID use after Achilles tendon ruptures will be associated with worse functional recovery.
Significance: Emergency Department providers commonly prescribe NSAIDs for pain control following fractures and tendon injuries. However, the implications of this practice on bone and tendon healing are unknown. This proposal will pilot the first prospective, randomized, double-blinded study to determine whether NSAID use affects healing after tibia fractures and Achilles tendon ruptures. Results from this study will impact NSAID prescribing patterns for tibia fractures and Achilles tendon ruptures in the ED, either by demonstrating that they impair recovery and should be avoided, or that they need not be withheld as an effective non-narcotic form of pain control.
|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Injury||Drug: Ibuprofen 600 mg Drug: Acetaminophen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||456 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||NSAID Use and Healing After Tibia Fractures and Achilles Tendon Ruptures|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Active Comparator: Acetaminophen
Patients will receive 650mg PO Acetaminophen every 6 hours as needed for pain
acetaminophen 600mg po q6 hours prn pain
Active Comparator: Ibuprofen
Patients will receive 600mg PO Ibuprofen every 6 hours as needed for pain
Drug: Ibuprofen 600 mg
ibuprofen 600mg Po q 6 hours prn pain
- Incidence of non-union after tibia fracture [ Time Frame: 6 months ]Fractures
- Functional Recovery after Achilles Tendon Rupture [ Time Frame: 6 months ]Achilles Tendon Total Rupture Score measures functional recovery after Achilles tendon rupture on a scale of 0 (worse) to 100 (best).
- Functional Impairment after Tibia Fracture on a scale of 1 to 3 (none to severe) [ Time Frame: 6 months ]The score quantifies functional impairment on a scale of 1 (none) to 3 (severe)
- Degree of pain after Tibia Fracture on a scale of 1-9 [ Time Frame: 6 months ]The score quantifies pain on a scale of 1 (none) to 9 (severe)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880981
|Contact: Vanessa Franco, MD PhD||(310) firstname.lastname@example.org|
|Principal Investigator:||Vanessa Franco, MD PhD||Assistant Professor|