Effective orthotic therapy for the painful cavus foot: a randomized controlled trial. A prospective study of the effect of foot orthoses composition and fabrication on comfort and the incidence of overuse injuries. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. A randomized controlled trial of foot orthoses in rheumatoid arthritis. Randomized trial of botulinum toxin to prevent pes cavus progression in pediatric Charcot-Marie-Tooth disease type 1A. A randomized controlled trial of two types of in-shoe orthoses in children with flexible excess pronation of the feet. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. Foot orthoses for the treatment of plantar fasciitis. A controlled randomized study of the effect of training with orthoses on the incidence of weight bearing induced back pain among infantry recruits. Impacts of foot orthoses on pain and disability in rheumatoid arthritics. Can custom-made biomechanic shoe orthoses prevent problems in the back and lower extremities? A randomized, controlled intervention trial of 146 military conscripts.
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. 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. 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. 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. 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. 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 foot orthoses in the management of patellofemoral pain syndrome with flat inserts or physiotherapy, and to investigate the effectiveness of foot orthoses plus physiotherapy.
                Prospective, single blind, randomised clinical trial.
                Single centre trial within a community setting in Brisbane, Australia.
                179 participants (100 women) aged 18 to 40 years, with a clinical diagnosis of patellofemoral pain syndrome of greater than six weeks' duration, who had no previous treatment with foot orthoses or physiotherapy in the preceding 12 months.
                Six weeks of physiotherapist intervention with off the shelf foot orthoses, flat inserts, multimodal physiotherapy (patellofemoral joint mobilisation, patellar taping, quadriceps muscle retraining, and education), or foot orthoses plus physiotherapy.
                Global improvement, severity of usual and worst pain over the preceding week, anterior knee pain scale, and functional index questionnaire measured at 6, 12, and 52 weeks.
                Foot orthoses produced improvement beyond that of flat inserts in the short term, notably at six weeks (relative risk reduction 0.66, 99% confidence interval 0.05 to 1.17; NNT 4 (99% confidence interval 2 to 51). No significant differences were found between foot orthoses and physiotherapy, or between physiotherapy and physiotherapy plus orthoses. All groups showed clinically meaningful improvements in primary outcomes over 52 weeks.
                While foot orthoses are superior to flat inserts according to participants' overall perception, they are similar to physiotherapy and do not improve outcomes when added to physiotherapy in the short term management of patellofemoral pain. Given the long term improvement observed in all treatment groups, general practitioners may seek to hasten recovery by prescribing prefabricated orthoses.
                Australian Clinical Trials Registry ACTRN012605000463673 and ClinicalTrials.gov NCT00118521. The literature suggests mechanical interventions such as foot orthoses and night splints are effective in reducing pain from plantar fasciitis. There is, however, a lack of controlled trials. We studied the effects of foot orthoses and night splints, alone or combined, in a prospective, randomized trial with 1-year followup.
                Forty-three patients (34 women and nine men with a mean age of 46 years) with plantar fasciitis were randomized to receive foot orthoses (n = 13), foot orthoses and night splints (n = 15), or night splints alone (n = 15). Data were available for 34 (79%) patients after treatment (12 weeks), and for 38 (88%) at 1-year followup. Pain, functional limitations, and quality of life were evaluated with the Foot and Ankle Outcome Score.
                All groups improved significantly in all outcomes evaluated across all times (p < 0.04). At 12 weeks, pain reduction of 30% to 50% compared to baseline were seen (p < 0.03). At 52 weeks, pain reduction of 62% was seen in the two groups using foot orthoses compared to 48% in the night splint only group (p < 0.01). Better compliance and fewer side effects were reported for orthosis use. At 12 months, 19 of 23 patients reported still using foot orthoses compared to 1 of 28 still using the night splint.
                Foot orthoses and anterior night splints were effective both short-term and long-term in treating pain from plantar fasciitis. Parallel improvements in function, foot-related quality of life, and a better compliance suggest that a foot orthosis is the best choice for initial treatment plantar fasciitis. 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. Rheumatoid arthritis (RA) frequently causes foot pain and swelling that affect ambulation. Pharmaceutical management of pain and disability is standard in clinical practice. The use of functional posted foot orthoses, as an adjunct to pharmaceutical treatment, is a promising treatment for managing foot pain and disability in RA. Its effectiveness, however, has not been rigorously evaluated. We performed a double-blind clinical trial using foot orthoses vs. placebo orthoses in the management of the rheumatoid arthritic foot, while subjects continued customary treatment. On the basis of findings of no effect on disability and pain measures, this study indicates no benefit of functional posted foot orthoses over placebos. Shock-absorbing and biomechanic shoe orthoses are frequently used in the prevention and treatment of back and lower extremity problems. One review concludes that the former is clinically effective in relation to prevention, whereas the latter has been tested in only 1 randomized clinical trial, concluding that stress fractures could be prevented.
                To investigate if biomechanic shoe orthoses can prevent problems in the back and lower extremities and if reducing the number of days off-duty because of back or lower extremity problems is possible.
                Prospective, randomized, controlled intervention trial.
                One female and 145 male military conscripts (aged 18 to 24 years), representing 25% of all new conscripts in a Danish regiment.
                Health data were collected by questionnaires at initiation of the study and 3 months later. Custom-made biomechanic shoe orthoses to be worn in military boots were provided to all in the study group during the 3-month intervention period. No intervention was provided for the control group. Differences between the 2 groups were tested with the chi-square test, and statistical significance was accepted at P <.05. Risk ratio (RR), risk difference (ARR), numbers needed to prevent (NNP), and cost per successfully prevented case were calculated.
                Outcome variables included self-reported back and/or lower extremity problems; specific problems in the back or knees or shin splints, Achilles tendonitis, sprained ankle, or other problems in the lower extremity; number of subjects with at least 1 day off-duty because of back or lower extremity problems and total number of days off-duty within the first 3 months of military service because of back or lower extremity problems.
                Results were significantly better in an actual-use analysis in the intervention group for total number of subjects with back or lower extremity problems (RR 0.7, ARR 19%, NNP 5, cost 98 US dollars); number of subjects with shin splints (RR 0.2, ARR 19%, NNP 5, cost 101 US dollars); number of off-duty days because of back or lower extremity problems (RR 0.6, ARR < 1%, NNP 200, cost 3750 US dollars). In an intention-to-treat analysis, a significant difference was found for only number of subjects with shin splints (RR 0.3, ARR 18%, NNP 6 cost 105 US dollars), whereas a worst-case analysis revealed no significant differences between the study groups.
                This study shows that it may be possible to prevent certain musculoskeletal problems in the back or lower extremities among military conscripts by using custom-made biomechanic shoe orthoses. However, because care-seeking for lower extremity problems is rare, using this method of prevention in military conscripts would be too costly. We also noted that the choice of statistical approach determined the outcome.
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.