Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. Physiotherapy, including quadriceps exercises and patellar taping, for knee osteoarthritis with predominant patello-femoral joint involvement: randomized controlled trial. Effective orthotic therapy for the painful cavus foot: a randomized controlled trial. Metatarsalgia and rheumatoid arthritis--a randomized, single blind, sequential trial comparing 2 types of foot orthoses and supportive shoes. A randomized controlled trial of two types of in-shoe orthoses in children with flexible excess pronation of the feet. Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Effect of a novel insole on the subtalar joint of patients with medial compartment osteoarthritis of the knee. A randomized controlled trial of foot orthoses in rheumatoid arthritis. Static and isokinetic treatments of chondromalacia patella: a comparative investigation.
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. To design and carry out a randomized controlled trial of a complex, physical therapy based intervention for patello-femoral joint (PFJ) osteoarthritis (OA) of the knee, examining medium to longterm outcomes.
                The participants, who had knee pain and predominant PFJ OA, were recruited from a large population based study. The study design was a controlled trial using prerandomization and a blind observer, comparing the intervention package with standard nonphysiotherapy treatment. The physiotherapy intervention was delivered in local community health centers and clinics and comprised education, quadriceps and functional exercises, and patellar taping delivered by a single physiotherapist in nine 30-minute sessions over 10 weeks, with advice to continue thereafter. The outcome measures were pain in the worse knee by 100 mm visual analog scale score, the disability domain of the Western Ontario and McMaster University OA index (WOMAC), and quadriceps muscle strength by maximum voluntary contraction.
                Eighty-seven patients were recruited to the study, 43 were randomized to the treatment arm. At 5 months post-baseline (10 weeks post-treatment) the treatment group had a small decrease in pain and a significant increase in quadriceps strength of the index knee. After one year there were no significant differences in any outcome measure, most of which had returned towards pretreatment levels.
                The treatment package produced small improvements in knee pain scores and quadriceps muscle strength 10 weeks after the end of the treatment period. There was no difference between the 2 groups at 12 months. 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. 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. 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. 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 assess the efficacy of a lateral wedge insole with elastic strapping of the subtalar joint for conservative treatment of osteoarthritis (OA) of the knee.
                The efficacy of a novel insole with elastic subtalar strapping and a traditional shoe insert wedge insole was compared. Ninety female outpatients with OA of the knee were treated with wedge insoles for 8 weeks. Randomization was performed according to birth date. Standing radiographs with unilateral insole use were used to analyze the femorotibial and talar tilt angles for each patient with and without their respective insole. Visual analog scale (VAS) score for subjective knee pain at the final assessment was compared with that at baseline in both groups.
                Participants wearing the elastically strapped insole (n = 46) had significantly decreased femorotibial angle (p < 0.0001) and talar tilt angle (p = 0.005) and significantly improved VAS pain score (p = 0.045) in comparison with baseline assessments. These significant differences were not found in the group with the inserted insole (n = 44).
                The novel strapped insole leads to valgus angulation of the talus, resulting in correction of the femorotibial angle in patients with knee OA with varus deformity, and may have a therapeutic effect similar to that of high tibial osteotomy. 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. Literature on the comparative effectiveness of nonoperative treatments for patellofemoral pathologies has been limited. The purpose of this investigation was to study the effectiveness of selected static and isokinetic physical therapy rehabilitation programs for subjects with a clinical diagnosis of chondromalacia patella. Criteria employed to assess the effects of these therapeutic programs included measures of knee functional capacity as measured by the Cincinnati Rating System and traditional measures of leg strength and flexibility. Twenty-nine subjects were screened by an orthopaedic physician and assigned to a control (N = 9), static (N = 11), or isokinetic (N = 9) exercise group. Noncontrol subjects were administered a program of 12 treatments, three times a week, for four weeks by a registered physical therapist. Results of the ANCOVA for 17 pretest and posttest measures indicated that the static and isokinetic groups demonstrated significant (P < 0.05) functional improvements over the control group in walking, stair activity, running, jumping/twisting, and overall activity level as well as increased quadriceps strength and hamstring range of motion. No significant differences, however, were determined to exist between the static and isokinetic groups. The major implication of this investigation is that static and isokinetic treatment programs provide positive and comparable rehabilitation effects on the functional capacity of the knee joint for subjects with chondromalacia patella. Static therapy, however, appears to be most cost-effective. J Orthop Sports Phys Ther 1990;12(6):256-266.
While not robust, the available evidence does not reveal any clear advantage of foot orthoses over simple insoles or physiotherapy for patellofemoral pain. While foot orthoses may help relieve knee pain over the short term, the benefit may be marginal. Patients treated with orthoses are more likely to complain of mild adverse effects and discomfort.