Effective orthotic therapy for the painful cavus foot: a randomized controlled trial. Randomized trial of botulinum toxin to prevent pes cavus progression in pediatric Charcot-Marie-Tooth disease type 1A. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. A prospective study of the effect of foot orthoses composition and fabrication on comfort and the incidence of overuse injuries. A randomized controlled trial of two types of in-shoe orthoses in children with flexible excess pronation of the feet. Efficacy of custom foot orthotics in improving pain and functional status in children with juvenile idiopathic arthritis: a randomized trial. A controlled randomized study of the effect of training with orthoses on the incidence of weight bearing induced back pain among infantry recruits. A randomized controlled trial of foot orthoses in rheumatoid arthritis. Metatarsalgia and rheumatoid arthritis--a randomized, single blind, sequential trial comparing 2 types of foot orthoses and supportive shoes.
Patients with a cavus or high-arched foot frequently experience foot pain, which can lead to significant limitation in function. Custom foot orthoses are widely prescribed to treat cavus foot pain. However, no clear guidelines for their construction exist, and there is limited evidence of their efficacy. In a randomized, single-blind, sham-controlled trial, the effect of custom foot orthoses on foot pain, function, quality of life, and plantar pressure loading in people with a cavus foot type was investigated. One hundred fifty-four participants with chronic musculoskeletal foot pain and bilateral cavus feet were randomly assigned to a treatment group receiving custom foot orthoses (n = 75) or to a control group receiving simple sham insoles (n = 79). At 3 months, 99% of the participants provided follow-up data using the Foot Health Status Questionnaire. Foot pain scores improved more with custom foot orthoses than with the control (difference, 8.3 points; 95% confidence interval [CI], 1.2 to 15.3 points; P = .022). Function scores also improved more with custom foot orthoses than with the control (difference, 9.5 points; 95% CI, 2.9 to 16.1 points; P = .005). Quality-of-life data favored custom foot orthoses, although differences reached statistical significance only for physical functioning (difference, 7.0 points; 95% CI, 1.9 to 12.1 points; P = .008). Plantar pressure improved considerably more with custom foot orthoses than with the control for all regions of the foot (difference, -3.0 N . s/cm(2); 95% CI, -3.7 to -2.4 N . s/cm(2); P < .001). In conclusion, custom foot orthoses are more effective than a control for the treatment of cavus foot pain and its associated limitation in function. Pes cavus in Charcot-Marie-Tooth disease type 1A (CMT1A) is thought to be due to muscle imbalance of the lower leg. Botulinum toxin type A (BoNT-A) can modify foot deformity in other conditions of muscle imbalance. We tested the safety and effectiveness of BoNT-A on pes cavus progression in pediatric CMT1A. A 24-month, randomized, single-blind trial of BoNT-A was undertaken in 10 affected children (20 legs), aged 3-14 years. The treated leg received intramuscular BoNT-A injections at 6-month intervals in the tibialis posterior and peroneus longus. The control leg received no injections. Primary outcome was radiographic alignment at 24 months. Secondary outcomes were foot posture, ankle flexibility, and strength, assessed every 6 months. Radiographically, BoNT-A produced a small non-significant reduction in cavus progression. There was no effect of BoNT-A on secondary outcomes. There were no serious adverse events. At 24 months, the intramuscular BoNT-A injections proved safe and well-tolerated but did not affect the progression of pes cavus in CMT1A. Plantar fasciitis is one of the most common foot complaints. It is often treated with foot orthoses; however, studies of the effects of orthoses are generally of poor quality, and to our knowledge, no trials have investigated long-term effectiveness. The aim of this trial was to evaluate the short- and long-term effectiveness of foot orthoses in the treatment of plantar fasciitis.
                A pragmatic, participant-blinded, randomized trial was conducted from April 1999 to July 2001. The duration of follow-up for each participant was 12 months. One hundred and thirty-five participants with plantar fasciitis from the local community were recruited to a university-based clinic and were randomly allocated to receive a sham orthosis (soft, thin foam), a prefabricated orthosis (firm foam), or a customized orthosis (semirigid plastic).
                After 3 months of treatment, estimates of effects on pain and function favored the prefabricated and customized orthoses over the sham orthoses, although only the effects on function were statistically significant. Compared with sham orthoses, the mean pain score (scale, 0-100) was 8.7 points better for the prefabricated orthoses (95% confidence interval, -0.1 to 17.6; P = .05) and 7.4 points better for the customized orthoses (95% confidence interval, -1.4 to 16.2; P = .10). Compared with sham orthoses, the mean function score (scale, 0-100) was 8.4 points better for the prefabricated orthoses (95% confidence interval, 1.0-15.8; P = .03) and 7.5 points better for the customized orthoses (95% confidence interval, 0.3-14.7; P = .04). There were no significant effects on primary outcomes at the 12-month review.
                Foot orthoses produce small short-term benefits in function and may also produce small reductions in pain for people with plantar fasciitis, but they do not have long-term beneficial effects compared with a sham device. The customized and prefabricated orthoses used in this trial have similar effectiveness in the treatment of plantar fasciitis. Foot orthoses are widely prescribed both to treat existing pathological conditions and to prevent overuse injuries, but little is known about the effect of their material composition and fabrication technique on patient comfort and the incidence of overuse injuries.
                The acceptance rates and comfort scores of soft custom, soft prefabricated, semirigid biomechanical, and semirigid prefabricated orthoses and their effect on the incidence of stress fractures, ankle sprains, and foot problems were studied in a prospective, randomized, single-blinded clinical trial among 874 infantry recruits during basic training.
                A statistically significantly lower number of recruits given soft prefabricated orthoses (53%) finished basic training in their assigned devices than in the soft custom group (72%), in the semirigid biomechanical group (75%), and in the semirigid prefabricated group (82%) (p = .003). For recruits who finished training in their assigned orthoses, the soft custom (3.54) and soft prefabricated (3.43) orthoses had significantly higher comfort scores than the semirigid biomechanical (3.23) and prefabricated (3.17) orthoses, (p = .0001). There was no statistically significant difference in the incidence of stress fractures, ankle sprains, or foot problems between recruits using the different types of orthoses.
                These findings suggest that if a foot orthosis is being dispensed as prophylaxis for overuse injuries in an active, healthy population, there is little justification for prescribing semirigid biomechanical orthoses. Their cost is high compared to other types of orthoses, without an advantage in comfort or a reduction in stress fractures, ankle sprains, and foot problems. Orthoses for children with flexible excess pronation are estimated to cost Australian parents millions of dollars per year; however, there is no high-level evidence that orthoses improve function or reduce pain.
                A randomized parallel, single-blinded, controlled trial of custom-made and ready-made orthoses was conducted in children between the ages of 7 and 11 years with bilateral flexible excess pronation. The diagnosis was based on calcaneal eversion and navicular drop. Outcomes included gross motor proficiency, self-perception, exercise efficiency, and pain. Measurements were taken at baseline, and at 3 and 12 months. Of the 178 children who participated at baseline, 160 continued to the end of the trial.
                After randomization, baseline characteristics were similar between the three treatment groups (custom-made, ready-made, and control). Statistical modeling demonstrated that although for most outcome measures there were statistically significant trends over time, none of the group comparisons were statistically significant. A sub-group analysis of those presenting with pain found no significant differences at 3 or 12 months.
                This study found no evidence to justify the use of in-shoe orthoses in the management of flexible excess foot pronation in children. . To compare the clinical efficacy of custom foot orthotics, prefabricated "off-the-shelf" shoe inserts, and supportive athletic shoes worn alone, on reducing pain and improving function for children with juvenile idiopathic arthritis (JIA).
                Children with JIA and foot pain (n = 40) were randomized to one of 3 groups receiving: (1) custom-made semirigid foot orthotics with shock absorbing posts (n = 15), (2) off-the-shelf flat neoprene shoe inserts (n = 12), or (3) supportive athletic shoes with a medial longitudinal arch support and shock absorbing soles worn alone (n = 13). Foot pain and functional limitations were measured using the Pediatric Pain Questionnaire-visual analog scale (VAS), Timed Walking, Foot Function Index (FFI), and the Physical Functioning Subscale of the Pediatric Quality of Life Inventory (PedsQL). Measures were administered by personnel blinded to group status at baseline (before wearing the assigned intervention) and at 3 months' followup.
                Children in the orthotics group showed significantly greater improvements in overall pain (p = 0.009), speed of ambulation (p = 0.013), activity limitations (p = 0.002), foot pain (p = 0.019), and level of disability (p = 0.024) when compared with the other 2 groups. Both children and parents in the orthotics group reported clinically meaningful improvement in child health-related quality of life, although the group by time interaction did not show statistical significance. Except for a reduction in pain for supportive athletic shoes (paired t test, p = 0.011), neither the off-the-shelf shoe inserts nor the supportive athletic shoes worn alone showed significant effect on any of the evaluation measures.
                In children with JIA, custom-made semirigid foot orthotics with shock-absorbing posts significantly improve pain, speed of ambulation, and self-rated activity and functional ability levels compared with prefabricated off-the-shelf shoe inserts or supportive athletic shoes worn alone. Randomized controlled trial.
                To determine if the use of custom shoe orthoses can lessen the incidence of weight bearing-induced back pain.
                The scientific basis for the use of orthoses to prevent back pain is based principally on studies that show that shoe orthoses can attenuate the shock wave generated at heel strike. The repetitive impulsive loading that occurs because of this shock wave can cause wear of the mechanical structures of the back. Previous randomized studies showed mixed results in preventing back pain, were not blinded, and used orthoses for only short periods of time.
                A total of 404 eligible new infantry recruits without a history of prior back pain were randomly assigned to received either custom soft, semirigid biomechanical, or simple shoe inserts without supportive or shock absorbing qualities. Recruits were reviewed biweekly by an orthopaedist for back signs and symptoms during the course of 14 weeks of basic training
                The overall incidence of back pain was 14%. By intention-to treat and per-protocol analyses, there was no statistically significant difference between the incidence of either subjective or objective back pain among the 3 treatment groups. Significantly more recruits who received soft custom orthoses finished training in their assigned orthoses (67.5%) than those who received semirigid biomechanical orthoses (45.5%) or simple shoe inserts (48.6%), P = 0.001.
                The results of this study do not support the use of orthoses, either custom soft or semirigid biomechanical, as prophylactic treatment for weight bearing-induced back pain. Custom soft orthoses had a higher utilization rate than the semirigid biomechanical or simple shoe inserts. The pretraining physical fitness and sports participation of recruits were not related to the incidence of weight bearing-induced back pain. To investigate the clinical effectiveness of early foot orthosis intervention for painful correctable valgus deformity of the rearfoot in rheumatoid arthritis (RA).
                Patients with RA were randomized to receive custom manufactured rigid foot orthoses under podiatry supervision (n = 50) or enter a control group (n = 48). The control group received foot orthoses only when prescribed under normal medical care. Foot pain and disability, using the Foot Function Index (FFI), along with disease activity, tolerance, and adverse reactions, were serially measured over 30 mo continuous treatment.
                The group assigned foot orthoses demonstrated an immediate clinical improvement, the effect peaking at 12 mo. At 30 mo the FFI total score was reduced by 23.1% from baseline in the intervention group. Area under the curve analysis showed a statistically significant reduction in FFI scores for total score (p = 0.026), foot pain (p = 0.014), and foot disability (p = 0.016) when intervention was compared to control scores. There were no confounding effects from differences between groups for disease activity or pharmacological or other management strategies. Most patients (96%) used their orthoses and most found them comfortable (97%), although minor adverse reactions, such as tender spots, blisters, and callus, were reported in 30% of patients in the early stages of treatment and persisted in 12% for 30 mo.
                Custom designed foot orthoses used continuously over a 30 mo treatment period resulted in a reduction in foot pain by 19.1%, foot disability by 30.8%, and functional limitation by 13.5%. Clinical effectiveness might be enhanced by their use in the early stages of rearfoot pain and deformity. To compare the effects of semi-rigid and soft orthoses worn in supportive shoes, and supportive shoes worn alone, on metatarsal phalangeal (MTP) joint pain. MTP joint synovitis, and lower extremity function in patients with rheumatoid arthritis.
                Twenty-eight subjects referred to occupational therapy received in random order 3 interventions for 12 week trials, separated by 2 week washouts. A crossover design compared effectiveness of interventions.
                Twenty-four subjects completed the study. A reduction in mean pain scores from baseline to final visits showed that semi-rigid orthoses had a highly significant effect on pain. Soft orthoses did not show a significant effect on pain from baseline to final visit, nor did shoes worn alone. None of the interventions had a significant effect on synovitis or function.
                Semi-rigid orthoses worn in supportive shoes were an effective treatment for metatarsalgia. Supportive shoes worn alone or worn with soft orthoses did not provide pain relief for metatarsalgia.
This updated review shows that custom-made foot orthoses are significantly more beneficial than sham orthoses for treating foot pain associated with pes cavus in a variety of clinical populations. We also show that some secondary biomechanical outcomes improve with custom-made foot orthoses and footwear, but not with botulinum toxin or off-the-shelf foot orthoses. There is an absence of evidence for any other type of intervention for the treatment or prevention of pes cavus.