Neurocryostimulation for the Treatment of Acute Lateral Ankle Sprain : a Single Blind Randomized Controlled Trial
Description:
Lateral ankle sprain (LAS) is one of the most common reasons for primary care office and
emergency department visits, with an overall incidence of 2.15 per 1,000 person-years in the
United States.In its acute phase, LAS is associated with swelling, haematoma and pain over
the anterior talofibular and calcaneofibular ligaments, as well as ligamentous laxity of
these ligaments. Interventions following acute LAS are based upon the three stages of
biological ligament healing: inflammatory phase, proliferation phase (6 weeks to 3 months
after trauma) and remodelling or maturation phase (until 1 year after trauma). The initial
treatment during inflammatory phase is directed towards avoiding or diminishing excess
swelling and ongoing injury, thus optimizing the healing process. Therefore, RICE (Rest, Ice
[cryotherapy], Compression, Elevation) is the treatment of choice for the first 7 to 10 days
to reduce pain and swelling. Cryotherapy has been used for a long time in rehabilitation;
mainly using ice, cool packs or cold water. Lately, a new device, the CRYOFOS, has been
developed to provide more performing ways to use cryotherapy. CRYOFOS uses a fluid
(hyperbaric CO²) that is sprayed in the form of dry ice on the body region to be treated. It
leads to a so-called thermal shock, which sees the skin temperature cooled from 32 ˚C to 2-4
˚C in 30 sec.While CRYOFOS seems, theoretically, better than other cooling procedures, its
superiority has never been determined following acute injuries such as LAS. Considering the
extensive use of cold in the management of acute LAS, it would be even more relevant to
examine the impact of cryotherapy on both the reduction of symptoms and the functional
limitations of subjects who sustained a LAS.
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). Secondary outcomes will include the level of ankle pain, evaluated using Numeric Pain
Rating Scales (NPRS), weight-bearing ankle dorsiflexion range of motion (also called Bent
Knee DorsiFlexion test), assessed with the maximal advancement of the tibia over the talus in
a weight-bearing position, and joint swelling, using the Figure-of-Eight method.
Both groups will 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. However, for the
experimental group, CRYOFOS will be applied on the ankle at the end of each of the 8 sessions
(in accordance to the protocol established).
Descriptive statistics will be used for all outcome measures at each measurement time to
summarise results. Baseline demographic data will be compared (independent t-test and
Chi-squared tests) to establish the comparability of groups. All data will be tested to check
the distributional assumptions for the inferential statistical analyses. An
intention-to-treat analysis will be used in which all participants will be analysed in the
group to which they were originally assigned. All dropouts and the reason for dropping out of
the study will be reported. Any harm or unintended effects during the programs will be
recorded. A 2-way ANOVA (2 cryotherapy [CRYOFOS or Ice] x 5 Time [baseline, day 7, week 2,
week 4, week 6]) will be used to analyse the effects of CRYOFOS on primary outcome (LEFS) and
secondary outcomes (SPSS 22, proc GENLIN [Generalized Estimating Equations for repeated
measures]).
Condition:
Ankle Sprain
Treatment:
Neurocryostimulation
Start Date:
June 2015
Sponsor:
Laval University
For More Information:
https://clinicaltrials.gov/show/NCT02945618