NCT02667730

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

3.9 years

First QC Date

July 9, 2015

Last Update Submit

February 9, 2024

Conditions

Ligament Injury

Outcome Measures

Primary Outcomes (1)

  • Ankle Function on FAAM

    Foot and Ankle Abilities Measure

    3 months

Secondary Outcomes (5)

  • Pain on visual analogue scale (VAS)

    3 months

  • Mobility on Wall Lunge

    3 months

  • Laxity on anterior drawer test

    3 months

  • Proprioception on SEBT

    3 months

  • composite of health resource consumption

    1 year

Study Arms (4)

Physiotherapy only

PLACEBO COMPARATOR

This group will receive non-pharmacological advice and physiotherapy only

Other: physiotherapy only

Acetaminophen + physiotherapy

EXPERIMENTAL

This group will receive acetaminophen 500mg 4 times daily for 7 days in addition to standardized physiotherapy

Drug: AcetaminophenOther: physiotherapy only

Naproxen + physiotherapy

EXPERIMENTAL

This group will receive naproxen 500mg twice daily for 7 days in addition to standardized physiotherapy

Drug: NaproxenOther: physiotherapy only

Celecoxib + physiotherapy

EXPERIMENTAL

This group will receive celecoxib 100mg twice daily for 7 days in addition to standardized physiotherapy

Drug: CelecoxibOther: physiotherapy only

Interventions

AcetaminophenDRUG

Acetaminophen 500 mg four times daily for 7 days

Also known as: tylenol
Acetaminophen + physiotherapy
NaproxenDRUG

naproxen 500mg twice daily for 7 days

Naproxen + physiotherapy
CelecoxibDRUG

celecoxib 100mg twice daily

Also known as: celebrex
Celecoxib + physiotherapy
physiotherapy onlyOTHER

physiotherapy only (no drug)

Acetaminophen + physiotherapyCelecoxib + physiotherapyNaproxen + physiotherapyPhysiotherapy only

Eligibility Criteria

Age17 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2 Fd Amb medical clinic

Petawawa, Ontario, K8H2X9, Canada

Location

MeSH Terms

Interventions

AcetaminophenNaproxenCelecoxib

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsBenzenesulfonamidesSulfonamidesBenzene DerivativesSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Koren Lui, BScPHM

    Canadian Forces Health Services Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2015

First Posted

January 29, 2016

Study Start

June 1, 2015

Primary Completion

May 1, 2019

Study Completion

December 1, 2021

Last Updated

February 12, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)