Clinical trial
Correlation Between Acute Analgesia and Long-Term Function Following Ankle
Name
2013-12-126-004-0001
Description
In this 4-arm pragmatic randomized control trial, the investigators hope to decipher whether the use of non-opioid analgesics (naproxen, celecoxib, acetaminophen) in addition to standardized physiotherapy during the acute phase of grade I-II ankle injuries will result in functional differences compared to standardized physiotherapy alone
Trial arms
Trial start
2015-06-01
Estimated PCD
2019-05-01
Trial end
2021-12-01
Status
Completed
Phase
Early phase I
Treatment
Acetaminophen
Acetaminophen 500 mg four times daily for 7 days
Arms:
Acetaminophen + physiotherapy
Other names:
tylenol
Naproxen
naproxen 500mg twice daily for 7 days
Arms:
Naproxen + physiotherapy
Celecoxib
celecoxib 100mg twice daily
Arms:
Celecoxib + physiotherapy
Other names:
celebrex
physiotherapy only
physiotherapy only (no drug)
Arms:
Acetaminophen + physiotherapy, Celecoxib + physiotherapy, Naproxen + physiotherapy, Physiotherapy only
Size
168
Primary endpoint
Ankle Function on FAAM
3 months
Eligibility criteria
Inclusion Criteria:
* Acquired acute ankle injury (injured less than 48 hours ago);
* Clinical diagnosis of a Grade I or II ankle sprain
* Is eligible to receive comprehensive medical care from Garrison Petawawa
Exclusion Criteria:
* Diagnosis of ankle fracture or ligament rupture
* Has planned release from the Canadian Armed Forces within one year;
* Documented restrictions on military duties
* Has known intolerance or documented adverse reaction to acetaminophen or naproxen or celecoxib
* Documented history of liver or kidney problems
* pregnant or breastfeeding
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Patients are aware of their allocation. The treating physiotherapists will not be aware of allocation and patients are asked to not discuss their medication (allocation) with physiotherapists', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 168, 'type': 'ACTUAL'}}
Updated at
2024-02-12
1 organization
2 products
1 drug
1 indication
Organization
Canadian Department of National DefenseProduct
AcetaminophenIndication
Ligament InjuryProduct
NaproxenDrug
Celecoxib