- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02667730
Correlation Between Acute Analgesia and Long-Term Function Following Ankle Injuries (CALF)
Correlation Between Acute Analgesia and Long-Term Function Following Ankle
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background Ankle sprains occur frequently in the Canadian Armed Forces (CAF) population and account for a significant proportion of lost work time. Equally significant is the use of analgesics (NSAID or non-NSAID) (NSAID = non steroidal anti-inflammatory drug) in the CAF population. Existing literature suggests that the rate and extent of soft tissue healing may be adversely affected by use of some analgesics, particularly non-steroidal anti-inflammatory agents (NSAIDs), when these are used immediately following joint injury. There have been two postulated mechanisms for this observation: the first being that inflammatory markers are required in the regeneration process; the second is that the diminished pain level as a result of analgesic use encourages overuse of the injured tissue. Unfortunately, the science is far from conclusive, since much of it is derived based on isolated exercises, conducted in experimental settings, in older populations, or extrapolated from biomarkers that have not been validated for clinical relevance. While there is no current standard of practice regarding the use of pain relievers following ankle injury, this practice continues to be widespread in the CAF.
Goal The proposed study aims to clarify whether three commonly used non-opioid pain relievers provide additional benefit or delay improvement in ankle function following mild ankle sprains, when compared to standardized physiotherapy treatment alone. The three agents investigated will be 1) the non-steroid anti-inflammatory drug naproxen, 2) the selective anti-inflammatory celecoxib, and 3) the centrally-acting analgesic acetaminophen.
Methods Patients presenting to the health clinic at Garrison Petawawa with acute ankle injuries will be screened for study eligibility. All individuals who elect to participate in this study will be referred for standardized physiotherapy treatment, which will be administered according to study protocol. Participants will also be randomized to one of four analgesic treatment groups (i.e., naproxen, celecoxib, acetaminophen, or non-pharmacological measures only), with stratification for grade of ankle injury. Physiotherapists who are blinded to analgesic treatment allocation will evaluate participants' ankle function at 72 hours, 2 weeks, 3 months and 1 year post-injury, using previously validated tests. Pharmacists will assess response to drug therapy, side effects, and use of rescue medications at day 7 following enrollment. Occurrence of repeat ankle injuries and health resource consumption (i.e., specialist visits and diagnostic imaging) will also be assessed for the year following index injury.
Risks This study is intended to be low risk to participants as it is designed to closely mirror existing practices for such injuries. All medications used in this study are indicated for soft tissue injuries and their respective dosages/frequencies/durations aligned with manufacturer recommendations. The physiotherapy intervention was developed by Dr. Eric Robitaille. It has been used in previous studies and is currently in use in the CAF. The investigators do not expect the risk of injury to be higher than that associated with existing practices for ankle injuries.
Benefits Participants are expected to benefit from the direct application of a standardized physiotherapy treatment protocol for overall management of their condition as well as the pain relief from the analgesic options. The results of this study are expected to generate new information that can be readily applied to patient care, specifically in treating a frequently-occurring soft tissue injury in the CAF population.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Koren Lui, BScPHM
- Phone Number: 647 296 5121
- Email: koren.lui@forces.gc.ca
Study Locations
-
-
Ontario
-
Petawawa, Ontario, Canada, K8H2X9
- 2 Fd Amb medical clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Physiotherapy only
This group will receive non-pharmacological advice and physiotherapy only
|
physiotherapy only (no drug)
|
Experimental: Acetaminophen + physiotherapy
This group will receive acetaminophen 500mg 4 times daily for 7 days in addition to standardized physiotherapy
|
physiotherapy only (no drug)
Acetaminophen 500 mg four times daily for 7 days
Other Names:
|
Experimental: Naproxen + physiotherapy
This group will receive naproxen 500mg twice daily for 7 days in addition to standardized physiotherapy
|
physiotherapy only (no drug)
naproxen 500mg twice daily for 7 days
|
Experimental: Celecoxib + physiotherapy
This group will receive celecoxib 100mg twice daily for 7 days in addition to standardized physiotherapy
|
physiotherapy only (no drug)
celecoxib 100mg twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle Function on FAAM
Time Frame: 3 months
|
Foot and Ankle Abilities Measure
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain on visual analogue scale (VAS)
Time Frame: 3 months
|
visual analogue scale
|
3 months
|
Mobility on Wall Lunge
Time Frame: 3 months
|
wall lunge test for ankle mobility
|
3 months
|
Laxity on anterior drawer test
Time Frame: 3 months
|
test for laxity
|
3 months
|
Proprioception on SEBT
Time Frame: 3 months
|
star excursion balance test
|
3 months
|
composite of health resource consumption
Time Frame: 1 year
|
# of orthopedic specialist consults, diagnostics, patient encounters for MSK reasons, # of days off work
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Koren Lui, BScPHM, Canadian Forces Health Services Group
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Cyclooxygenase 2 Inhibitors
- Gout Suppressants
- Celecoxib
- Acetaminophen
- Naproxen
Other Study ID Numbers
- 2013-12-126-004-0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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