NCT02945618

Brief Summary

The objective of this exploratory randomized control trial is to compare, in participants with acute lateral ankle sprain (LAS) , the reduction of symptoms and functional limitations between two groups of subjects who undergo a conventional rehabilitation program with (experimental group) or without CRYOFOS (comparison group). The hypothesis is that CRYOFOS will lead to a faster reduction of symptoms and functional limitations, and a faster return to daily living activities.Thirty-six participants of 18 years of age and older with acute LAS (sustained a LAS three days or less before the first evaluation session) will be recruited and randomly assigned to either a group receiving conventional rehabilitation program with the addition of CRYOFOS (experimental group; n=18), or to a group only receiving the conventional rehabilitation program (comparison group; n=18). This single-blind (evaluator), parallel-group RCT will include five evaluation sessions over 6 weeks (baseline, day 7, week 2, week 4 and week 6) and 8 treatment sessions (1st and 2nd weeks: 3 sessions/week; 3rd and 4th weeks: 1 session/week) during a 4-week period. The primary outcome will be the functional limitations, evaluated using the Lower Extremity Functional Scale (LEFS).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

October 23, 2016

Last Update Submit

August 29, 2017

Conditions

Ankle Sprain

Keywords

cryotherapyphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in lower limb functional level at 6 weeks

    Lower Extremity Functional Scale (LEFS), an auto-administered questionnaire of functional capacity

    Baseline-6 weeks

Secondary Outcomes (12)

  • Change from Baseline in pain level at 6 weeks

    Baseline-6 weeks

  • Change from Baseline in pain level at 1 week

    Baseline-1 week

  • Change from Baseline in pain level at 2 weeks

    Baseline-2 weeks

  • Change from Baseline in pain level at 4 weeks

    Baseline-4 weeks

  • Change from Baseline in ankle oedema at 6 weeks

    Baseline-6 weeks

  • +7 more secondary outcomes

Study Arms (2)

Neurocryostimulation

EXPERIMENTAL

CRYOFOS will be applied on the ankle at the end of each of the 8 sessions (in accordance to the protocol established). The treatment time with the CRYOFOS will take between 1 and 2 minutes, and will be pain-free. Both groups will also receive the same conventional program consisting of: compression, bracing, early mobilization (including manual therapy), strengthening (isometric and isotonic using elastic bands) and proprioception (using proprioception boards) exercises, according to the grade of the sprain and the stage of biological ligament healing.

Device: Neurocryostimulation

Conventional program with ice

ACTIVE COMPARATOR

The control group will receive the same conventional program (as the experimental group) consisting of: compression, bracing, early mobilization (including manual therapy), strengthening (isometric and isotonic using elastic bands) and proprioception (using proprioception boards) exercises, according to the grade of the sprain and the stage of biological ligament healing. Ice will be applied to the ankle for 15 minutes at the end of each of the 8 sessions.

Other: Ice

Interventions

NeurocryostimulationDEVICE

CRYOFOS will be applied on the ankle at the end of each of the 8 sessions (in accordance to the protocol established). The treatment time with the CRYOFOS will take between 1 and 2 minutes, and will be pain-free. Both groups will also receive the same conventional program consisting of: compression, bracing, early mobilization (including manual therapy), strengthening (isometric and isotonic using elastic bands) and proprioception (using proprioception boards) exercises, according to the grade of the sprain and the stage of biological ligament healing.

Also known as: Hyperbaric gazeous cryotherapy, Cryostimulation
Neurocryostimulation
IceOTHER

The control group will receive the same conventional program (as the experimental group) consisting of: compression, bracing, early mobilization (including manual therapy), strengthening (isometric and isotonic using elastic bands) and proprioception (using proprioception boards) exercises, according to the grade of the sprain and the stage of biological ligament healing. Ice will be applied to the ankle for 15 minutes at the end of each of the 8 sessions.

Also known as: Conventional program with ice
Conventional program with ice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LAS three days or less before the first evaluation session
  • presence of a lateral hematoma and swelling
  • tenderness at the anterior lateral ligament without or with anterior drawer instability

You may not qualify if:

  • present a bony ankle injury (indicated by Ottawa ankle rules)
  • had sustained a similar injury of the same joint within the last 6 months
  • require bed rest, hospitalisation, casting or surgery
  • had a previous fracture of the same ankle
  • signs or symptoms of a previous injury at any of the other joints of the lower limbs or trunk
  • contraindication to cryotherapy including cryoglobulinemia, peripheral vascular disease or Raynaud's syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laval University

Québec, G1V 0A6, Canada

RECRUITING

Related Publications (1)

  • Tittley J, Hebert LJ, Roy JS. Should ice application be replaced with neurocryostimulation for the treatment of acute lateral ankle sprains? A randomized clinical trial. J Foot Ankle Res. 2020 Dec 1;13(1):69. doi: 10.1186/s13047-020-00436-6.

    PMID: 33261633DERIVED

MeSH Terms

Conditions

Ankle Injuries

Interventions

Ice

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

WaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsEnvironmentEcological and Environmental PhenomenaBiological PhenomenaWeatherMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Jean-Sebastien Roy, PhD

    Universite Laval

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Sebastien Roy, PT, PhD

CONTACT

1-418-529-9141jean-sebastien.roy@rea.ulaval.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 23, 2016

First Posted

October 26, 2016

Study Start

June 1, 2015

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

August 30, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)