title: Surgery vs orthosis vs watchful waiting for hallux valgus: a randomized controlled trial. Manufactured Shoes in the Prevention of Diabetic Foot Ulcers The foot function index with verbal rating scales (FFI-5pt): A clinimetric evaluation and comparison with the original FFI. Effect of therapeutic footwear on foot reulceration in patients with diabetes: a randomized controlled trial. Off-loading the diabetic foot wound: a randomized clinical trial. Off-the-shelf orthopedic footwear for people with rheumatoid arthritis. The Foot Function Index: a measure of foot pain and disability. Evaluation of magnetic foil and PPT Insoles in the treatment of heel pain.
abstract: CONTEXT Hallux valgus is a common foot deformation in adults , but evidence for effectiveness of surgical and conservative treatments for this condition is limited . OBJECTIVE To compare the effectiveness of surgical and orthotic treatment with no treatment in patients with hallux valgus . DESIGN AND SETTING R and omized controlled trial conducted in 4 general community hospitals in Finl and in 1997 - 1998 , with a follow-up period of 12 months . PARTICIPANTS Two hundred nine consecutive patients ( mean age , 48 years ; 93 % women ) with a painful bunion and a hallux valgus angle 35 degrees or less . INTERVENTIONS Patients were r and omly assigned to surgery ( distal chevron osteotomy ; n = 71 ) , orthosis ( n = 69 ) , or a 1-year waiting list ( control group , n = 69 ) . MAIN OUTCOME MEASURES Pain intensity during walking on a visual analog scale ( 0 - 100 ) , patient assessment of global improvement , number of painful days , cosmetic disturbance , footwear problems , functional status , and treatment satisfaction , compared among treatment groups . RESULTS Follow-up rates at 6 and 12 months were 99 % and 98 % , respectively . At 6 months , pain intensity decreased more in the surgical group than in the control group ( adjusted mean differences , -20 [ 95 % confidence interval ( CI ) , -28 to -12 ] ) and more in orthosis than in the control groups ( adjusted mean difference , -14 [ 95 % CI , -22 to -6 . At 1 year , pain intensity decreased more in the surgical than in the control groups ( adjusted mean difference , -19 [ 95 % CI , -28 to -10 ] ) and more than in the surgical and orthosis groups ( adjusted mean difference , -14 [ 95 % CI , -22 to -5 ] ) . At 1 year , 83 % , 46 % , and 24 % in the surgery , orthosis , and control groups , respectively , thought they had improved compared with baseline ( number needed to treat ) , 1.7 between surgical and control groups ) . Number of painful days , cosmetic disturbance , and footwear problems were least and functional status and satisfaction with treatment were best in the surgical group . CONCLUSIONS Surgical osteotomy is an effective treatment for painful hallux valgus . Orthoses provide short-term symptomatic relief OBJECTIVE To evaluate the efficacy of manufactured shoes specially design ed for diabetic patients ( Podiabetes by Buratto Italy ) to prevent relapses of foot ulcerations . RESEARCH DESIGN AND METHODS A prospect i ve multicenter r and omized follow-up study of patients with previous foot ulcerations was conducted . Patients were alternatively assigned to wear either their own shoes ( control group , C ; n = 36 ) or therapeutic shoes ( Podiabetes group , P ; n = 33 ) . The number of ulcer relapses was recorded during 1-year follow-up . RESULTS Both C and P groups had similar risk factors for foot ulceration ( i.e. , previous foot ulceration , mean vibratory perception threshold > 25 mV ) . After 1 year , the foot ulcer relapses were significantly lower in P than in C ( 27.7 vs. 58.3 % ; P = 0.009 ; odds ratio 0.26 [ 0.2–1.54 ] ) . In a multiple regression analysis , the use of therapeutic shoes was negatively associated with foot ulcer relapses ( coefficient of variation = −0.315 ; 95 % confidence interval = −0.54 to −0.08 ; P = 0.009 ) . CONCLUSIONS The use of specially design ed shoes is effective in preventing relapses in diabetic patients with previous ulceration OBJECTIVE To assess the clinimetric value of the Dutch version of the Foot Function Index ( FFI ) in comparison with the original FFI using verbal rating scales ( FFI-5pt ) rather than visual analog scales ( VAS ) . METHODS A prospect i ve study was performed on 206 patients with nontraumatic forefoot complaints . Scoring , internal consistency , and construct validity of the FFI-5pt were compared with those of the original FFI , which rates all items on VAS . We also studied agreement between the scores at baseline and after one and 8 weeks and the scale scores with regard to sex , age , presence of osteoarthritis , limitation of mobility , bodily pain , and poor physical functioning ( using SF-36 ) . RESULTS Some items were not applicable ; removal of these items left 2 scales ( Pain and Disability ) with high internal consistency ( alpha = 0.88 to 0.94 ) and good agreement between both versions ( intraclass correlation coefficient 0.64 to 0.79 ) . Principal component analysis with varimax rotation using a forced 2 factor model fitted well ( 65 % explained variance ) . Test-retest reliability was high ( ICC 0.70 to 0.83 ) , while the stability over 8 weeks was lower , but still good ( ICC 0.63 to 0.71 ) . Responsiveness to change was low to moderate . However , a small number of patients reported an overall change ( 19 % ) . Scores of patients with limited mobility and poor physical health ( SF-36 ) were higher than those of patients with fewer physical problems , indicating good concurrent validity . CONCLUSION The FFI-5pt is a suitable generic measure . Its clinimetric properties are comparable with those of the original FFI . Its administration and data entry are less time consuming . However , responsiveness has to be more exactly assessed in an intervention study CONTEXT Many people with diabetes experience lower-limb ulcers . Footwear has been implicated as a primary cause of foot ulcers , yet research is limited on the efficacy of shoe and insert combinations to prevent reulceration . OBJECTIVE To determine whether extra-depth and -width therapeutic shoes used with 2 types of inserts reduce reulceration in diabetic individuals with a history of foot ulcer . DESIGN , SETTING , AND PARTICIPANTS R and omized clinical trial of 400 diabetes patients with history of foot ulcer in 2 Washington State health care organizations who did not require custom shoes for foot deformity and were enrolled between August 1997 and December 1998 and followed up for 2 years . Data collected at regular intervals documented physical , foot , and diabetes characteristics ; footwear use ; foot lesions ; and ulcers . INTERVENTIONS Participants were r and omly assigned to receive 3 pairs of therapeutic shoes and 3 pairs of customized medium-density cork inserts with a neoprene closed-cell cover ( n = 121 ) ; to receive 3 pairs of therapeutic shoes and 3 pairs of prefabricated , tapered polyurethane inserts with a brushed nylon cover ( n = 119 ) ; or to wear their usual footwear ( controls ; n = 160 ) . MAIN OUTCOME MEASURE Foot reulceration , compared among the 3 groups . RESULTS Two-year cumulative reulceration incidence across the 3 groups was low : 15 % in the cork-insert group , 14 % in the prefabricated-insert group , and 17 % in controls . In the intent-to-treat analysis , patients assigned to therapeutic shoes did not have a significantly lower risk of reulceration compared with controls ( risk ratio [ RR ] for the cork-insert group , 0.88 ; 95 % confidence interval [ CI ] , 0.51 - 1.52 and RR the for prefabricated-insert group , 0.85 ; 95 % CI , 0.48 - 1.48 ) . All ulcer episodes in patients assigned to therapeutic shoes and 88 % wearing non study shoes occurred in patients with foot insensitivity . CONCLUSIONS This study of persons without severe foot deformity does not provide evidence to support widespread dispensing of therapeutic shoes and inserts to diabetic patients with a history of foot ulcer . Study shoes and custom cork or preformed polyurethane inserts conferred no significant ulcer reduction compared with control footwear . This study suggests that careful attention to foot care by health care professionals may be more important than therapeutic footwear but does not negate the possibility that special footwear is beneficial in persons with diabetes who do not receive such close attention to foot care by their health care providers or in individuals with severe foot deformities OBJECTIVE To compare the effectiveness of total-contact casts ( TCCs ) , removable cast walkers ( RCWs ) , and half-shoes to heal  neuropathic foot ulcerations in individuals with diabetes . RESEARCH DESIGN AND METHODS In this prospect i ve clinical trial , 63 patients with superficial noninfected , nonischemic diabetic plantar foot ulcers were r and omized to one of three off-loading modalities : TCC , half-shoe , or RCW . Outcomes were assessed at wound healing or at 12 weeks , whichever came first . Primary outcome measures included proportion of complete wound healing at 12 weeks and activity ( defined as steps per day ) . RESULTS The proportions of healing for patients treated with TCC , RCW , and half-shoe were 89.5 , 65.0 , and 58.3 % , respectively . A significantly higher proportion of patients were healed by 12 weeks in the TCC group when compared with the two other modalities ( 89.5 vs. 61.4 % , P = 0.026 , odds ratio 5.4 , 95 % CI 1.1 - 26.1 ) . There was also a significant difference in survival distribution ( time to healing ) between patients treated with a TCC and both an RCW ( P = 0.033 ) and half-shoe ( P = 0.012 ) . Patients were significantly less active in the TCC ( 600.1 + /- 320.0 daily steps ) compared with the half-shoe ( 1,461.8 + /- 1,452.3 daily steps , P = 0.04 ) . There was no significant difference in the average number of steps between the TCC and the RCW ( 767.6 + /- 563.3 daily steps , P = 0.67 ) or the RCW and the half-shoe ( P = 0.15 ) . CONCLUSIONS The TCC seems to heal a higher proportion of wounds in a shorter amount of time than two other widely used off-loading modalities , the RCW and the half-shoe OBJECTIVES To assess the effectiveness of off-the-shelf orthopedic footwear for people with rheumatoid arthritis ( RA ) reporting chronic foot pain , in terms of self-reported pain and physical function , as well as objective ly measured gait variables using an electric footswitch walkway . METHODS A small , r and omized , controlled trial followed by a larger repeated measures analysis was used . RESULTS The control group ( n = 15 ) demonstrated no significant changes over a 2-month period in pain , physical function , or gait scores . In contrast , after supply of the footwear both the original footwear group ( n = 15 ) and the control group demonstrated significant improvements , with small to large effect sizes , in weight-bearing pain scores , physical function , gait velocity , and gait stride length without increases in use of arthritis medications or walking aids . CONCLUSION These data suggest that off-the-shelf orthopedic footwear is beneficial for people with RA even when subjects were unselected on basis of age , sex , disease duration , or disability as measured by the Stanford Health Assessment Question naire A Foot Function Index ( FFI ) was developed to measure the impact of foot pathology on function in terms of pain , disability and activity restriction . The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales . Both total and sub-scale scores are produced . The FFI was examined for test-retest reliability , internal consistency , and construct and criterion validity . A total of 87 patients with rheumatoid arthritis were used in the study .  Test-retest reliability of the FFI total and sub-scale scores ranged from 0.87 to 0.69 . Internal consistency ranged from 0.96 to 0.73 . With the exception of two items , factor analysis supported the construct validity of the total index and the sub-scales . Strong correlation between the FFI total and sub-scale scores and clinical measures of foot pathology supported the criterion validity of the index . The FFI should prove useful for both clinical and research purpose The effect of a magnetic foil placed in the PPT/Rx Firm Molded Insole on the relief of heel pain was determined using the foot function index . Nineteen patients wore the PPT/Rx Firm Molded Insoles with the magnetic foil for 4 weeks and 15 patients wore the same PPT/Rx Firm Molded Insole with no magnetic foil for the same time . Approximately 60 % of patients in both groups reported improvement . There was also no significant difference in the improvement between the magnetic foil group and the PPT/Rx Firm Molded Insole group in their scores on the post-treatment foot function index . These results suggest that the PPT/Rx Firm Molded Insole alone was effective in treating heel pain after only 4 weeks . The magnetic foil offered no advantage over the plain insole
target: The present review shows that current scientific literature concerning the usability of orthopaedic shoes focuses mainly on effectiveness at the expense of the other domains of usability , i.e. , efficiency , satisfaction and context of use
background: Objective : To determine the method ological quality of studies evaluating  orthopaedic shoes and orthopaedic shoe provisions .
  To what extent do studies evaluating  orthopaedic shoes prescribed for patients with degenerative disorders of the foot , rheumatoid arthritis , diabetes mellitus and neurological foot disorders , focus on the aspects of the International Organization for St and ardization ( ISO ) definition of usability , i.e. , effectiveness , efficiency , satisfaction , and context of use ?