Study design
Single-blind parallel group randomized clinical trial.
Objectives
To compare the effects of neurocryostimulation (NCS) with those of traditional ice application on functional recovery, pain, edema and ankle dorsiflexion range of motion (ROM) in individuals receiving physiotherapy treatments for acute lateral ankle sprains (LAS).
Background
Ankle sprain is a very common injury and its management is often costly, with important short- and long-term impacts on individuals and society. As new methods of therapy using cold (cryotherapy) are emerging for the treatment of musculoskeletal conditions, little evidence exists to support their use. NCS, which provokes a rapid cooling of the skin with the liberation of pressured CO2, is a method believed to accelerate the resorption of edema and recovery in the case of traumatic injuries.
Methods
Forty-one participants with acute LAS were randomly assigned either to a group that received in-clinic physiotherapy treatments and NCS (experimental NCS group, n = 20), or to a group that received the same in-clinic physiotherapy treatments and traditional ice application (comparison ice group, n = 21). Primary (Lower Extremity Functional Scale - LEFS) and secondary (visual analog scale for pain intensity at rest and during usual activities in the last 48 h, Figure of Eight measurement of edema, and weight bearing lunge for ankle dorsiflexion range of motion) outcomes were evaluated at baseline (T0), after one week (T1), two weeks (T2), four weeks (T4) and finally, after six weeks (T6). The effects of interventions were assessed using two-way ANOVA-type Nonparametric Analysis for Longitudinal Data (nparLD).
Results
No significant group-time interaction or group effect was observed for all outcomes (0.995 ≥ p ≥ 0.057) following the intervention. Large time effects were however observed for all outcomes (p < 0.0001).
Conclusion
Results suggest that neurocryostimulation is no more effective than traditional ice application in improving functional recovery, pain, edema, and ankle dorsiflexion ROM during the first six weeks of physiotherapy treatments in individuals with acute LAS.
Level of evidence
Therapy, level 1b.
Trial registration
ClinicalTrials.gov, NCT02945618. Registered 23 October 2016 - Retrospectively registered (25 participants recruited prior to registration, 17 participants after).
