Clinical Outcomes between Using Prefabricated Toe Sleeve versus Toe Separator in Patients with Painful Hallux Valgus: A Single-Blinded Randomized Control Trial
Keywords:bunion, foot orthoses, hallux valgus, pain
Objectives: To compare clinical outcomes between using a prefabricated foot-toe orthosis, a toe sleeve and a toe separator in treating painful hallux valgus/bunion.
Study design: A single-blinded randomized controlled trial.
Setting: Ramathibodi Hospital, Bangkok, Thailand.
Subjects: Patients with painful hallux valgus/bunion aged between 25 and 70 years old
Methods: Patients were randomly divided into two groups: a toe separator and a toe sleeve group, both received the same treatment protocols. Primary outcomes were pain using a visual analog scale (VAS) and functions using visual analog scale-foot and ankle (VAS-FA) at one- and three-month follow-ups, and patient compliance with adherence to daily use of the orthosis as a secondary outcome.
Results: Compared with the baseline, the mean VAS at one- and three-month follow-ups statistically significantly decreased in both groups [the toe sleeve group: 55.72, 21.72 and 19.33 (p < 0.01); the toe separator group: 66.00, 42.67 and 42.17 (p < 0.01) respectively]. The mean VAS-FA at both follow-ups statistically significantly increased in both groups [the former toe sleeve group:75.89, 88.67 and 83.83 (p = 0.01), the toe separator group: 53.72, 65.33 and 71.17 (p < 0.01), respectively]. The toe sleeve group showed significantly lower VAS scores than the toe separator group at both follow-ups, whereas the VAS-FA did not differ.
Conclusions: The toe sleeve significantly reduced pain better than the toe separator did in patients with hallux valgus at 1 and 3 months after usage. The VAS-FA also significantly improved in both groups without a significant inter-group difference. Both, a toe sleeve and a toe separator, improved functions.
Keywords: bunion, foot orthoses, hallux valgus, pain
Nix S, Smith M, Vicenzino B. Prevalence of hallux valgus in the general population: a systematic review and meta-analysis. J Foot Ankle Res. 2010;3:21.
Perera AM, Mason L, Stephens MM. The pathogenesis of hallux valgus. J Bone Joint Surg Am. 2011;93:1650-61.
Hart ES, deAsla RJ, Grottkau BE. Current concepts in the treatment of hallux valgus. Orthop Nurs. 2008;27:274-80; quiz 81-2.
Torkki M, Malmivaara A, Seitsalo S, Hoikka V, Laippala P, Paavolainen P. Surgery vs orthosis vs watchful waiting for hallux valgus: a randomized controlled trial. JAMA. 2001;285:2474-80.
Crevoisier X, Assal M, Stanekova K. Hallux valgus, ankle osteoarthrosis and adult acquired flatfoot deformity: a review of three common foot and ankle pathologies and their treatments. EFORT Open Rev. 2016;1:58-64.
Tehraninasr A, Saeedi H, Forogh B, Bahramizadeh M, Keyhani MR. Effects of insole with toe-separator and night splint on patients with painful hallux valgus: a comparative study. Prosthet Orthot Int. 2008;32:79-83.
Tang SF, Chen CP, Pan JL, Chen JL, Leong CP, Chu NK. The effects of a new foot-toe orthosis in treating painful hallux valgus. Arch Phys Med Rehabil. 2002;83:1792-5.
Chadchavalpanichaya N, Prakotmongkol V, Polhan N, Rayothee P, Seng-Iad S. Effectiveness of the custom-mold room temperature vulcanizing silicone toe separator on hallux valgus: A prospective, randomized single-blinded controlled trial. Prosthet Orthot Int. 2018;42:163-70.
Karabicak GO, Bek N, Tiftikci U. Short-Term Effects of Kinesiotaping on Pain and Joint Alignment in Conservative Treatment of Hallux Valgus. J Manipulative Physiol Ther. 2015;38:564-71.
Gur G, Ozkal O, Dilek B, Aksoy S, Bek N, Yakut Y. Effects of Corrective Taping on Balance and Gait in Patients With Hallux Valgus. Foot Ankle Int. 2017;38:532-40.
du Plessis M, Zipfel B, Brantingham JW, Parkin-Smith GF, Birdsey P, Globe G, et al. Manual and manipulative therapy compared to night splint for symptomatic hallux abducto valgus: an exploratory randomised clinical trial. Foot (Edinb). 2011;21:71-8.
Easley ME, Trnka HJ. Current concepts review: hallux valgus part 1: pathomechanics, clinical assessment, and nonoperative management. Foot Ankle Int. 2007;28:654-9.
Angthong C, Chernchujit B, Suntharapa T, Harnroongroj T. Visual analogue scale foot and ankle: validity and reliability of Thai version of the new outcome score in subjective form. J Med Assoc Thai. 2011;94:952-7.
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