The Effect of Ankle Muscles Dry Needling on Brain Activity Map Based on fMRI: a Study Protocol for Randomized Controlled Trial

Importance

Neuromodulation may be one of the underlying mechanisms of dry needling (DN); however, the mechanism has not yet been fully clarified.

Objective

This randomized controlled trial is designed to evaluate DN stimulation of the tibialis anterior and peroneus longus muscles in chronic ankle instability (CAI) and healthy subjects, employing functional magnetic resonance imaging (fMRI).

Design

Clinical study protocol, SPIRIT compliant.

Setting

Brain Mapping Laboratory.

Population

A total of thirty participants aged between 18 and 40 years old will be included in this study. Twenty healthy participants will be randomized into 2 groups (real DN and sham DN). Ten patients with CAI will also be recruited to the third group and receive only real DN for comparison.

Exposures

Real and sham DN.

Main Outcomes and Measures

The voxel count, coordinates of peak activation, and peak intensity will be obtained as primary outcomes to report brain map activation. Measurements will be taken before, during, and after DN treatment. The strength of the ankle dorsiflexors, active dorsiflexion range of motion, and McGill pain questionnaire short-form will be used as secondary outcome measures.

Results

The results from this study will be published in peer-reviewed journals and disseminated as presentations at national and international congresses.

Conclusion

This trial will explore brain responses to real and sham DN in healthy participants and to real DN in CAI patients. Overall, our results will provide preliminary evidence of the neural mechanism of DN.