The study was a prospective, randomized clinical trial involving 60 subjects, 30 in each group, selected from the general population. Group A received a progressive mobilization of the first metatarsophalangeal joint, used in conjunction with cryotherapy and adjustment of all other fixations found in the foot and ankle. Group B received placebo treatment de-tuned Action Potential Therapy. There were six treatments over a two-week period and a one-week follow-up consultation.
Objective assessment was made by a digital algometer and subjective assessment by the Numerical Pain Rating Scale-101 (NRS-101) and Foot Function Index (FFI). The Hallux-Metatarsophalangeal-Interphalangeal Scale (HAL) incorporated both objective and subjective measurements. Assessments were made at the first, third, sixth and one-week follow-up consultations.
Statistical analysis was completed at a 95% confidence interval. The parametric two-sampled paired t-test, the Friedman's test and the Dunn's post-test were used to analyse the data within each group (intra-group analysis), whilst the parametric two-sampled unpaired t-test and the non-parametric Mann–Whitney unpaired U-test were used to analyse the data between the two groups (inter-group analysis).
In terms of objective findings, analysis of the treatment group revealed a statistically significant improvement in the pressure-pain threshold (algometer readings) at each treatment interval, whereas the placebo group had no statistically significant improvement for this measurement.
In terms of the patients’ subjective response to treatment, both groups experienced a statistically significant decrease in pain perception (NRS-101) in the overall treatment interval; however, only the treatment group had a statistically significant improvement in pain perception at the early and intermediate intervals. A statistically significant improvement in the Foot Function Index (FFI), in terms of pain and disability experienced by the patient, was noted in the treatment group only.
On assessment of the Hallux-Metatarsophalangeal-Interphalangeal Scale, both groups revealed a statistically significant improvement in the overall treatment interval; however, the improvement in the placebo group was only found to be in the subjective aspect of the scale.
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