The clinical effects of pulsed electromagnetic field therapy for the management of chronic ankle instability: a study protocol for a double-blind randomized controlled trial.

BACKGROUND

Chronic ankle instability is associated with long-term neuromuscular deficits involving poor postural control and peroneal muscular impairment. Symptoms of chronic ankle instability hinder engagement in physical activity and undermine the patient's quality of life. Despite the existence of various treatment modalities, none has conclusively provided evidence of clinical effectiveness in counteracting neuromuscular deficits, such as arthrogenic muscle inhibition of the peroneal longus (PL). Pulse electromagnetic field therapy employed as an adjunct biophysical therapy can potentially improve stability by mitigating peroneal muscle weakness and by activating the peroneal muscle. We postulate that by combining standard care (muscle strengthening, balance training, and range of motion exercise) with pulse electromagnetic field therapy, postural control stability and peroneal muscle weakness will significantly improve.

METHODS

This is a prospective, randomized, double-blind, placebo-controlled trial. A total of 48 adults with chronic ankle instability will be recruited and randomly allocated into either the intervention or control groups. The intervention group (n = 24) will receive active pulse electromagnetic field therapy and standard exercise training, while the control group (n = 24) will receive sham pulse electromagnetic field therapy and standard exercise training for 8 weeks. Primary and secondary outcomes will be evaluated at baseline, week 4, 8 as well as at 3-, 6-, and 12-month follow-up visits.

DISCUSSION: Chronic ankle instability is a common debilitating condition without a curative conservative treatment. Investigating different treatment modalities will be essential for improving rehabilitation outcomes in this clinical population. This study will investigate the effectiveness of pulsed electromagnetic field therapy on the functional and clinical outcomes in the chronic ankle instability population. This trial may demonstrate this non-invasive biophysical therapy to be an effective measure to help patients with CAI.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05500885. Registered on August 13, 2022.