Should ice application be replaced with neurocryostimulation for the treatment of acute lateral ankle sprains? A randomized clinical trial

Abstract

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).

Keywords: Cryotherapy; Lateral ankle sprain; Neurocryostimulation; Rehabilitation.

Fig. 1

Study Design. NCS: neurocryostimulation

Fig. 2

Flowchart of Participants. MRI: magnetic resonance imaging; NCS: neurocryostimulation; PT: physiotherapist

Fig. 3

LEFS Scores. Lower Extremity Functional Scale (LEFS) mean scores (larger markers) for NCS group (n = 20) and ice group (n = 21), and individual scores (smaller markers). Higher scores indicate better function. Error bars show standard deviation (SD) of the means. NCS: neurocryostimulation

Fig. 4

Pain at Rest Scores. Pain intensity at rest during the last 48 h. Data show mean scores (larger markers) for NCS group (n = 20) and ice group (n = 21), and individual scores (smaller markers). Error bars show standard deviation (SD) of the means. NCS: neurocryostimulation; VAS: visual analog scale

Fig. 5

Pain during Usual Activities Scores. Pain intensity during usual activities for the last 48 h. Data show mean scores (larger markers) for NCS group (n = 20) and ice group (n = 21), and individual scores (smaller markers). Error bars show standard deviation (SD) of the means. NCS: neurocryostimulation; VAS: visual analog scale