Manual and manipulative therapy compared to night splint for symptomatic hallux abducto valgus: An exploratory randomised clinical trial

Abstract Context Hallux abducto valgus (HAV) is a frequent cause of great toe pain and disability, yet common treatments are only supported by mixed or equivocal research findings. Surgery often only provides modest improvement and post-surgery complications may significantly hamper outcomes, implying the need for trials testing conservative treatment, such as manual and manipulative therapy, particularly in cases where surgery may be contraindicated or premature. The purpose of this exploratory trial was to test an innovative protocol of manual and manipulative therapy (MMT) and compare it to standard care of a night splint(s) for symptomatic mild to moderate HAV, with a view gather insight into the effectiveness of MMT and inform the design of a definitive trial. Design Parallel-group randomised trial set in an out-patient teaching clinic. Participants A convenience sample of 75 patients was assessed for eligibility, with 30 participants (15 per group) being consented and randomly allocated to either the control group (standard care with a night splint) or the experimental group (MMT). Intervention Participants in the control group used a night splint(s) and those in the experimental group (MMT) received a structured protocol of MMT, with the participants in the experimental group receiving 4 treatments over a 2-week period. Outcome measures Visual analogue scale (HAV-related pain), foot function index (HAV-related disability) and hallux dorsiflexion (goniometry). Results There were no participant dropouts and no data was missing. There were no statistical ( p < 0.05) or clinically meaningful differences (MCID < 20%) between the two groups based on outcome measure scores. However, the outcome measure scores in the control group (night splint) regressed between the 1-week follow-up and 1-month follow-up, while the scores in the experimental group (MMT) were sustained up to the 1-month follow-up. The within-group data analysis produced statistically and clinically significant changes from baseline to the 1-week flow-up across all outcome measures. Post hoc power analysis and sample size calculations suggest that the average between group power of this trial was approximately 60% (ES = 0.33) and that a definitive trial would require a minimum of 102 participants per group ( N = 204) to achieve satisfactory power of ≥80%. Conclusions The trend in results of this trial suggest that an innovative structured protocol of manual and manipulative therapy (experime