***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: BACKGROUND 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 clinical ly effective in relation to prevention , whereas the latter has been tested in only 1 r and omized clinical trial , concluding that stress fractures could be prevented . OBJECTIVES 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 . DESIGN Prospect i ve , r and omized , controlled intervention trial . STUDY SUBJECTS One female and 145 male military conscripts ( aged 18 to 24 years ) , representing 25 % of all new conscripts in a Danish regiment . METHOD Health data were collected by question naires 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 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 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 . CONCLUSIONS 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 Orthotic insoles are suggested to prevent  low back pain . This r and omized controlled study assessed if customised orthotic insoles prevent low back pain .  Healthy military conscripts ( n = 228 ; mean age 19 years , range 18–29 ) were r and omly assigned to use either customised orthotic insoles ( treatment group , n = 73 ) or nothing ( control group , n = 147 ) . The main outcome measure was low back pain requiring a physician visit and result ing in minimum 1 day suspension from military duty . Twenty-four ( 33 % ) treated subjects and 42 ( 27 % ) control subjects were suspended from duty due to low back pain ( p = 0.37 ; risk difference 4.3 % ; 95 % CI : −8.7 to 17.3 % ) . Mean suspension duration was 2 days ( range 1–7 ) in both groups . Four ( 5 % ) treated subjects and eight ( 5 % ) control subjects were released from duty due to persistent low back pain ( p = 0.92 ; risk difference 0 % ; 95 % CI : −6 to 6 % ) . Use of orthotic insoles is therefore not recommended to prevent physical stress-related low back pain Study design : r and omized , double-blinded , clinical trial . Background : Low back pain is one of the commonest disorders affecting the back . The literature reflects how over time excessive pronation of the foot has become to be recognized as linked to chronic low back pain , and how the problem can evolve for the better with the use of compensating foot orthoses . Objectives : The main objective of this study is to answer the question of whether the use of a certain type of custom-made foot orthosis alleviates low back pain . Material and methods : In a sample of 51 participants with excessive subtalar pronation and chronic low back pain ( 43 women and 8 men ) , the effect of custom-made foot orthoses  in low back pain was studied . The study design was a r and omized , double-blinded , clinical trial with two groups : experimental , treated with the custom-made foot orthoses , and control , treated with a placebo .  Low back pain was evaluated by a visual analog scale for pain and Oswestry ’s Disability Index Question naire for lower back pain at two moments — on the day of inclusion in the study and after 4 weeks of treatment . Results : The evolution of the low back pain showed significant differences in the experimental group , showing a significant reduction of pain and disability ( p < 0.001 , visual analog scale ; p < 0.001 , Oswestry ’s Index ) . Conclusions : In the sample studied , the use of custom-made foot orthoses to control foot pronation had a short-term effect in reduction of perceived low back pain . Clinical relevance If subtalar joint hyperpronation plays a fundamental role in the pathomechanics of lower limb , and this can facilitate the development of low back pain , then controlling the abnormal mobility of subtalar joint by means of foot orthoses should improve this symptom . This article could help solve this controversy Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Study Design . R and omized controlled trial . Objectives . To determine if the use of custom shoe orthoses can lessen the incidence of weight bearing-induced back pain .  Summary of Background Data . 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 r and omized studies showed mixed results in preventing back pain , were not blinded , and used orthoses for only short periods of time . Methods . A total of 404 eligible new infantry recruits without a history of prior back pain were r and omly assigned to received either custom soft , semirigid biomechanical , or simple shoe inserts without supportive or shock absorbing qualities . Recruits were review ed biweekly by an orthopaedist for back signs and symptoms during the course of 14 weeks of basic training Results . 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 . Conclusions . 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 Objective 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 . Design Prospect i ve , single blind , r and omised clinical trial . Setting Single centre trial within a community setting in Brisbane , Australia . Participants 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 . Interventions 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 . Main outcome measures Global improvement , severity of usual and worst pain over the preceding week , anterior knee pain scale , and functional index question naire measured at 6 , 12 , and 52 weeks . Results 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 clinical ly meaningful improvements in primary outcomes over 52 weeks . Conclusion 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 . Trial registration Australian Clinical Trials Registry ACTRN012605000463673 and Clinical Trials.gov NCT00118521 OBJECTIVES The purpose of this pilot study was to investigate the feasibility of a r and omized clinical trial of shoe orthotics for chronic low back pain . METHODS The study recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area . Medical history and a low back examination were completed at a chiropractic clinic . Subjects were r and omized to either a treatment group receiving custom-made shoe orthotics or a wait-list control group . After 6 weeks , the wait-list control group also received custom-made orthotics . This study measured change in perceived pain levels ( Visual Analog Scale ) and functional health status ( Oswestry Disability Index ) in patients with chronic low back pain at the end of 6 weeks of orthotic treatment compared with no treatment and at the end of 12 weeks of orthotic treatment . RESULTS This study showed changes in back pain and disability with the use of shoe orthotics for 6 weeks compared with a wait-list control group . It appears that improvement was maintained through the 12-week visit , but the subjects did not continue to improve during this time . CONCLUSIONS This pilot study showed that the measurement of shoe orthotics to reduce low back pain and discomfort after 6 weeks of use is feasible . A larger clinical trial is needed to verify these results Soccer referees participating in large soccer tournaments may develop overuse injuries . In this study the effect of shock absorbing heel inserts in the incidence of soreness was investigated . Forty-eight referees were r and omly selected to wear shock absorbing heel inserts ( SAH ) in the 5 day-tournament , while 43 referees were the control group .  A daily question naire inquiring about complaints from the locomotive system was completed for each referee and in case of any soreness they were examined by doctors to document and classify the anatomical site . Calf , thigh , back , achilles tendon and knee were the most common localizations of overuse symptoms . The incidence of soreness in achilles tendon , calf and back were significantly reduced by the use of ( SAH ) inserts OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological 
    Output:
    
Conclusions There is insufficient evidence to support the use of insoles or foot orthoses as either a treatment for LBP or in the prevention of LBP .
Future research should concentrate on identification of LBP patients most suited to foot orthoses or insole treatment , as there is some evidence that trials structured along these lines have a greater effect on reducing LBP