Recruiting

Neurocryostimulation

Sponsor:

Laval University

Code:

NCT02945618

Conditions

Ankle Sprain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurocryostimulation

Ice

Study Details

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).

Conditions

Ankle Sprain

Study ID

NCT02945618

Start date

Jun, 2015

Status verified date

Aug, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Sep, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neurocryostimulation

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.

active comparator: Conventional program with ice

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.

Interventions

Neurocryostimulation

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.

Ice

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.

Primary outcome measure

  • Change from Baseline in lower limb functional level at 6 weeks [ Time Frame: Baseline-6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Laval University

Recruiting

Québec, Canada, G1V 0A6

Contacts

Principal Investigator:

Jean-Sébastien Roy, PhD

More Information

Sponsor

Laval University

Last update posted

Aug 30, 2017

Last verified

Aug, 2017

Keywords

  • cryotherapy
  • physical therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2017-08-30.