Flip-flop footwear with a moulded foot-bed for the treatment of foot pain: a randomised controlled trial

Abstract

BackgroundFoot pain is a common problem affecting up to 1 in 5 adults and is known to adversely affect activities of daily living and health related quality of life. Orthopaedic footwear interventions are used as a conservative treatment for foot pain, although adherence is known to be low, in part due to the perception of poor comfort and unattractiveness of the footwear. The objective of this trial was to assess the efficacy of flip-flop style footwear (Foot Bio-Tec©) with a moulded foot-bed in reducing foot pain compared to participant’s usual footwear.MethodsTwo-arm parallel randomised controlled trial using computer generated random allocation schedule at an Australian university podiatry clinic. 108 volunteers with disabling foot pain were enrolled after responding to an advertisement and eligibility screening. Participants were randomly allocated to receive footwear education and moulded flip-flop footwear to wear as much as they were comfortable with for the next 12 weeks (n = 54) or footwear education and instructions to wear their normal footwear for the next 12 weeks (n = 54). Primary outcome was the pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcomes were the foot function and general foot health domains of the FHSQ, a visual analogue scale (VAS) for foot pain and perceived comfort of the intervention footwear.ResultsCompared to the control group, the moulded flip-flop group showed a significant improvement in the primary outcome measure of the FHSQ pain domain (adjusted mean difference 8.36 points, 95 % CI 5.58 to 13.27, p < 0.01). Statistical and clinically significant differences were observed for the secondary measure of foot pain assessed by a VAS and the FSHQ domains of foot function and general foot health. None of the participants reported any pain or discomfort from the intervention footwear and six (footwear group = 4) were lost to follow up.ConclusionsOur results demonstrate that flip-flop footwear with a moulded foot-bed can have a significant effect on foot pain, function and foot health and might be a valuable adjunct therapy for people with foot pain.Trial registration ACTRN12614000933651. Retrospectively registered: 01/09/2014.

Effects of insoles adapted in flip-flop sandals in people with plantar fasciopathy: a randomized, double-blind clinical, controlled study

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The effects of shoe type on lower limb venous status during gait or exercise: A systematic review

“…For all other items, "yes" was scored 1 and "no" and "unable to determine" were scored 0. Based on the risk of bias assessment scores, studies were classified as very high quality/very low risk of bias (26)(27)(28), good quality/low risk of bias (20)(21)(22)(23)(24)(25), fair quality/fair risk of bias (15)(16)(17)(18)(19) or poor quality/high risk of bias (� 14) [43]. Higher scores indicated less risk of bias than lower scores.…”

“…The kinetics of venous return are dependent on contraction frequency, with variations in relaxation periods between the muscle contractions [16,64,67,68]. Walkeling et al [69] suggested that muscle fiber-type recruitment patterns can also be altered by the choice of shoes and the shoe's midsole material, and the study of Rao et al [70] showed lower amplitudes of the lateral Legend for the global score: excellent (26)(27)(28); good (20)(21)(22)(23)(24)(25); fair (15)(16)(17)(18)(19); and poor (< 14).…”

“….) and each type uses a different technology (e.g., rocker soles, unstable footwear, foot-bed, balance pods and multi-density soles) to reduce discomfort or pain [27,28] or improve recovery [26]. Moreover, several reviews have indicated that shoes particularly affect gait kinematics and kinetics both acutely and chronically [29][30][31][32][33][34].…”

Measures of Foot Pain, Foot Function, and General Foot Health

“…The FHSQ has been widely used as an outcome measure in clinical trials of treatments for nonspecific foot pain , plantar heel pain , first metatarsophalangeal joint osteoarthritis , interdigital neuroma , pes cavus , and rheumatoid arthritis .…”