COMPARAISON D’EFFICACITÉ ENTRE LA CRYOTHÉRAPIE GAZEUSE HYPERBARE ET LA CRYOTHÉRAPIE CONVENTIONNELLE DANS LE TRAITEMENT DES ENTORSES EXTERNES DE LA CHEVILLE Étude randomisée auprès d’Une Population de Militaires

Description:

In France, there is one ankle sprain per 10,000 person/day mainly as a result of athletic
practice. The military population is one of the most physically active populations due to
taking part in sports exercise, scheduled sports periods and leisure sports , or required
military exercise which increase the soldiers’ risk for injury to the lower extremity,
especially the ankle. The incidence rate for ankle sprain injuries among all -active-duty US
service members was 34.95 per 1000 person/year , thus more than 5 times greater than
previously reported in civilian studies reported in the literature. These are among the two
first leading causes of sports and physical training related hospitalizations among the U.S.
Army population.

Sprains can lead to numerous consequences in the long-term in physical restrictions such as,
ankle instability, risk of recurrence, but also absenteeism from work and/or participation in
sports and chronic pain. A more efficient treatment seems to be necessary in preventing such
troubles.

The usual care protocol for ankle sprains (RICE protocol) involve the cryotherapy (usually a
cold-pack (R) applied directly to the injury several times a day with no existing undesirable
effects).

An innovative treatment method, the neurocryostimulation, developed by Cluzeau and a French
Company in 1993, gained rapid and wide-spread use among physiotherapists, rheumatologists,
and athletes.It would provide a powerfull anti-inflammatory, myorelaxant and analgesic effect
but contradictory results are shown in literature. Demoulin et al. aimed to assess the
efficacy of neurocryostimulation following total knee arthroplasty compared to routinely used
strategies for applying cold therapy, but didn’t show significant differences regarding pain
severity, mobility and perimetric measures. However, a pilot study led in Switzerland,
comparing the pain reported by patients after an acute post-operative knee arthroscopy, has
shown a pain differential higher in the neurocryostimulation than in the referenced
cryotherapy (2.2 versus 0.5). And, Chatap et al. showed in a prospective study that pain
scores decreased significantly after four sessions in elderly patients with acute or chronic
pain.

At this day, No study has proved the efficacy of neurocryostimulation versus cold packs in
pain resulting from an ankle sprain . A better treatment of the ankle sprain could reduce
pain and , in the same time, also reduce the consumption of analgesics, the time of temporary
inaptitudes and of work exemptions.

Condition:

Sprain of Lateral Ligament of Ankle Joint

Treatment:

neurocryostimulation with Duo-cryo® device

Start Date:

September 2011

Sponsor:

Direction Centrale du Service de Santé des Armées

For More Information:

https://clinicaltrials.gov/show/NCT01716871