human
***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: Clinical research of grade d exposure in vivo with behavioral experiments in patients with chronic low back pain who reported fear of movement/(re)injury shows abrupt changes in self-reported pain-related fears and cognitions . The abrupt changes are more characteristics of insight learning rather than the usual gradual progression of trial and error learning . The educational session at the start of the exposure might have contributed to this insight . The current study examines the contribution of education and grade d exposure versus grade d activity in the reduction of pain-related fear and associated disability and physical activity .  Six consecutive patients with chronic low back pain who reported substantial fear of movement/(re)injury were included in the study . After a no-treatment baseline measurement period , all the patients received a single educational session , followed again by a no-treatment period . Patients were then r and omly assigned to either a grade d exposure with behavioral experiments or an operant grade d activity program . A diary was used to assess daily changes in pain intensity , pain-related fear , pain catastrophizing , and activity goal achievement . St and ardized question naires of pain-related fear , pain vigilance , pain intensity , and pain disability were administered before and after each intervention and at the 6-month follow-up . An activity monitor was carried at baseline , during the interventions , and 1 week at 6-month follow-up . R and omization tests of the daily measures showed that improvements in pain-related fear and catastrophizing occurred after the education was introduced . The results also showed a further improvement when exposure in vivo followed the no-treatment period after the education and not during the operant grade d activity program . Performance of relevant daily activities , however , were not affected by the educational session and improved significantly only in the exposure in vivo condition . All improvements remained at half-year follow-up only in patients receiving the exposure in vivo . These patients also reported a significant decrease in pain intensity at follow-up Introduction With the high incidence of knee osteoarthritis ( OA ) in Japan , there is a strong need not only for surgical therapies , but also for vali date d outcome measures . For this study , we completed cross-cultural adaptation , testing and validation of the Oxford knee score ( OKS ) for prospect i ve use in national and international clinical studies involving Japanese patients . Material s and methods The Japanese version of the OKS was developed according to the st and ard cross-cultural adaptation guidelines . For validation , the OKS was tested on 54 patients diagnosed with OA , osteonecrosis , ligament or meniscus injury . Reliability was tested using the intraclass correlation coefficient ( ICC ) . Internal consistency or homogeneity was assessed using Cronbach ’s alpha . The correlation between the Japanese OKS , WOMAC and SF-36 question naires was used to assess construct validity . Results No major difficulties were encountered with the translation and pre-testing stages . For reliability and validity , the Japanese OKS was completed without any missed responses by 53 ( 98.15 % ) and 52 ( 96.30 % ) patients at the first and second distribution , respectively . The total OKS showed good reliability with an ICC of 0.85 . Internal consistency was strong ( Cronbach ’s alpha = 0.90 ) . Strong construct validity ( ICC values of 0.51–0.84 ) was obtained against the WOMAC and SF-36 ( physical functioning , role-physical , bodily pain , and social functioning subscales ) scores . Notable “ ceiling ” effects of the OKS were reported for 11 of the 12 question naire items . Conclusion The Japanese OKS has proven to be a reliable and valid instrument for the self- assessment of knee pain and function in Japanese speaking patients with knee OA and other knee complaints BACKGROUND Osteoarthritis is a degenerative disease associated with pain , reduced range of motion , and impaired function . Balneotherapy or bathing in thermal or mineral waters is used as a non-invasive treatment for various rheumatic diseases . AIM To evaluate the effectiveness of hot sulfurous and non-sulfurous waters in the treatment of  knee osteoarthritis  . DESIGN A r and omized , assessor-blind , controlled trial . SETTING A spa resort . POPULATION One hundred and forty patients of both genders , mean age of 64.8±8.9 years , with knee osteoarthritis and chronic knee pain . METHODS Patients were r and omized into three groups : the sulfurous water ( SW ) group ( N.=47 ) , non-sulfurous water ( NSW ) group ( N.=50 ) , or control group ( N.=43 ) who received no treatment . Patients were not blinded to treatment allocation . Treatment groups received 30 individual thermal baths ( three 20-minute baths a week for 10 weeks ) at 37 - 39 ° C . The outcome measures were pain ( visual analog scale , VAS ) , physical function ( Western Ontario and McMaster Universities Osteoarthritis Index , WOMAC ; Lequesne Algofunctional Index , LAFI ; Stanford Health Assessment Question naire , HAQ ) , and use of pain medication . Patients were assessed before treatment ( T1 ) , at treatment endpoint ( T2 ) , and two months post-intervention ( T3 ) . Intra- and intergroup comparisons were performed at a significance level of 0.05 ( P<0.05 ) . RESULTS A significant decrease in VAS pain scores ( pain during movement , at rest , and at night ) and use of pain medication , and improvement in WOMAC , LAFI and HAQ scores were observed from baseline to T2 and T3 within treatment groups ( P<0.001 ) , and between controls and both treatment groups at T2 and T3 ( P<0.001 ) . No significant differences in these variables were observed between treatment groups at T2 , but patients in the SW group reported less pain and better functional status than those in the NSW group at T3 , showing a lasting effect of sulfurous water baths . CONCLUSIONS Both therapeutic methods were effective in the treatment of knee osteoarthritis ; however , sulfurous baths yielded longer-lasting effects than non-sulfurous water baths . CLINICAL REHABILITATION IMPACT Baths in thermal waters , especially those in sulfurous waters , are effective in reducing pain and improving physical function in patients with knee osteoarthritis We have developed a 12-item question naire for patients having a total knee replacement ( TKR ) . We made a prospect i ve study of 117 patients before operation and at follow-up six months later , asking them to complete the new question naire and the form SF36 . Some also filled in the Stanford Health Assessment Question naire ( HAQ ) . An orthopaedic surgeon completed the American Knee Society ( AKS ) clinical score . The single score derived from the new question naire had high internal consistency , and its reproducibility , examined by test-retest reliability , was found to be satisfactory . Its validity was established by obtaining significant correlations in the expected direction with the AKS scores and the relevant parts of the SF36 and HAQ . Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at follow-up . We also compared change in scores with the patients ' retrospective judgement of change in their condition . The effect size for the new question naire compared favourably with those for the relevant parts of the SF36 . The change scores for the new knee question naire were significantly greater ( p < 0.0001 ) for patients who reported the most improvement in their condition . The new question naire provides a measure of outcome for TKR that is short , practical , reliable , valid and sensitive to clinical ly important changes over time Background The Hospital Anxiety and Depression Scale ( HADS ) is a common screening instrument excluding somatic symptoms of depression and anxiety , but previous studies have reported inconsistencies of its factor structure . The construct validity of the Japanese version of the HADS has yet to be reported . To examine the factor structure of the HADS in a Japanese population is needed . Methods Exploratory and confirmatory factor analyses were conducted in the combined data of 408 psychiatric out patients and 1069 undergraduate students . The data pool was r and omly split in half for a cross validation . An exploratory factor analysis was performed on one half of the data , and the fitness of the plausible model was examined in the other half of the data using a confirmatory factor analysis . Simultaneous multi-group analyses between the subgroups ( out patients vs. students , and men vs. women ) were subsequently conducted . Results A two-factor model where items 6 and 7 had dual loadings was supported . These factors were interpreted as reflecting anxiety and depression . Item 10 showed low contributions to both of the factors . Simultaneous multi-group analyses indicated a factor pattern stability across the subgroups . Conclusion The Japanese version of HADS indicated good factorial validity in our sample s. However , ambiguous wording of item 7 should be clarified in future revisions Objective The aim of this study was to compare whether the effectiveness of continuous ultrasound ( US ) was superior against pulsed US and against sham US in knee osteoarthritis . Design A r and omized controlled study was carried out on 60 patients diagnosed with knee osteoarthritis according to American College of Rheumatology . The patients were r and omized into the following three treatments : ( 1 ) continuous US ( at a frequency of 1 MHz with intensity of 1 W/cm2 ) , ( 2 ) pulse US ( same frequency and intensity on 1:4 pulse ratio ) , and ( 3 ) sham US . All treatments were applied with 5-cm2 head US device five times a week for 2 weeks in addition to home exercise program including quadriceps isometric exercise , muscle strength exercises , and stretching exercises of the lower extremity muscles for at least three times per week . Assessment s were performed at baseline , at the end of the treatment , and at the end of the treatments and at the sixth month using the following measurements : Western Ontario and McMaster University Osteoarthritis Index – pain , stiffness , function , visual analog scale – pain at rest , visual analog scale – pain on movement , visual analog scale – disease severity , and 20-m walking time . Among these parameters , the Western Ontario and McMaster University Osteoarthritis Index – pain was the primary outcome . Results All groups showed a significant improvement in all parameters in both following visits ( P < 0.05 ) . However , there was no significant difference between the groups . Although the mean reduction percent in Western Ontario and McMaster University Osteoarthritis Index – pain was significantly higher in group I ( continuous US ) when compared to sham group ( 46.5 % vs 28.9 % , P < 0.05 ) at the end of the treatment , this result was not found in other pain parameters . Conclusions The present study demonstrated that all assessment parameters significantly improved in all groups without a significant difference . This result suggested that therapeutic US provided no additional benefit in improving pain and functions in addition to exercise training BACKGROUND Knee osteoarthritis ( OA ) conservative treatment aims to delay cartilage degeneration ; chondroprotective agents are a valid approach in this sense . A commercially available dietary supplement , CartiJoint Forte , containing glucosamine hydrochloride ( GH ) , chondroitin sulfate ( CS ) and Bio-Curcumin BCM-95 ® , was used in this trial . AIM The aim of this study was to assess efficacy and safety of CartiJoint Forte combined with physical therapy in treating subjects with knee OA . DESIGN A multicenter , prospect i ve , r and omized , double blind , placebo-controlled clinical trial . SETTING Out patients referred to the Rehabilitation Departments of two University Hospitals . POPULATION Fifty-three patients were r and omly assigned to an experimental group ( N=26 ) or a control group ( N.=27 ) . Experimental subjects received two tablets of CartiJoint Forte each day for 8 weeks , while those in the control group were provided with a placebo . Three subjects dropped out during the course of the study . METHODS The two groups both received 20 sessions of physical therapy during the course of the trial . Primary outcome was pain intensity , measured both at motion and at rest , using the Visual Analogue Scale ( VAS ) . A secondary outcome was an assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and Lequesne Index , knee ROM , and two inflammation markers ( C-reactive protein and erythrocyte sedimentation rate ) . Each assessment was carried out at baseline ( T0 ) , at 8 weeks ( T1 ) and at 12 weeks ( T2 ) . RESULTS VAS at rest was found to be reduced between T0 and T1 , as well as between T0 and T2 ( F=13.712 ; P=0.0001 ) , with no differences between groups ( F=1.724 ; P=0.191 ) . VAS at motion revealed a significant " group × time-check " interaction ( F=2.491 ; P=0.032 ) , with increasing effect of time on VAS reduction ( F=17.748 ; P=0.0001 ) . This was most pronounced in the experimental group at 8 weeks ( F=3.437 ; P=0.045 ) . The Lequesne Index showed reductions at T1 and T2 compared to T0 ( F=9.535 ; P=0.0001 ) , along with group effect , since the experimental group presented a lower score at T2 ( F=7.091 ; P=0.009 ) . No significant changes were found in the knee ROM and inflammation markers .  CONCLUSION CartiJoint Forte , added to physical therapy , may ameliorate pain and help to improve algofunctional score in knee OA patients . CLINICAL REHABILITATION IMPACT Treatment of knee OA with curcuminoids plus glycosaminoglycans , added to physical therapy , improves VAS at motion and Lequesne Index scores 
    Output:
    
agent
Results The FreKAQ-J had acceptable internal consistency , unidimensionality , good test-retest reliability , and was functional on the category rating scale .
The FreKAQ-J was significantly correlated with pain in motion , disability , pain-related catastrophizing , fear of movement , and anxiety symptomatology .
Conclusions We developed FreKAQ-J by modifying the FreBAQ-J. The FreKAQ-J fits the Rasch measurement model well and is suitable for use in people with knee OA .
***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: Clinical research of grade d exposure in vivo with behavioral experiments in patients with chronic low back pain who reported fear of movement/(re)injury shows abrupt changes in self-reported pain-related fears and cognitions . The abrupt changes are more characteristics of insight learning rather than the usual gradual progression of trial and error learning . The educational session at the start of the exposure might have contributed to this insight . The current study examines the contribution of education and grade d exposure versus grade d activity in the reduction of pain-related fear and associated disability and physical activity .  Six consecutive patients with chronic low back pain who reported substantial fear of movement/(re)injury were included in the study . After a no-treatment baseline measurement period , all the patients received a single educational session , followed again by a no-treatment period . Patients were then r and omly assigned to either a grade d exposure with behavioral experiments or an operant grade d activity program . A diary was used to assess daily changes in pain intensity , pain-related fear , pain catastrophizing , and activity goal achievement . St and ardized question naires of pain-related fear , pain vigilance , pain intensity , and pain disability were administered before and after each intervention and at the 6-month follow-up . An activity monitor was carried at baseline , during the interventions , and 1 week at 6-month follow-up . R and omization tests of the daily measures showed that improvements in pain-related fear and catastrophizing occurred after the education was introduced . The results also showed a further improvement when exposure in vivo followed the no-treatment period after the education and not during the operant grade d activity program . Performance of relevant daily activities , however , were not affected by the educational session and improved significantly only in the exposure in vivo condition . All improvements remained at half-year follow-up only in patients receiving the exposure in vivo . These patients also reported a significant decrease in pain intensity at follow-up Introduction With the high incidence of knee osteoarthritis ( OA ) in Japan , there is a strong need not only for surgical therapies , but also for vali date d outcome measures . For this study , we completed cross-cultural adaptation , testing and validation of the Oxford knee score ( OKS ) for prospect i ve use in national and international clinical studies involving Japanese patients . Material s and methods The Japanese version of the OKS was developed according to the st and ard cross-cultural adaptation guidelines . For validation , the OKS was tested on 54 patients diagnosed with OA , osteonecrosis , ligament or meniscus injury . Reliability was tested using the intraclass correlation coefficient ( ICC ) . Internal consistency or homogeneity was assessed using Cronbach ’s alpha . The correlation between the Japanese OKS , WOMAC and SF-36 question naires was used to assess construct validity . Results No major difficulties were encountered with the translation and pre-testing stages . For reliability and validity , the Japanese OKS was completed without any missed responses by 53 ( 98.15 % ) and 52 ( 96.30 % ) patients at the first and second distribution , respectively . The total OKS showed good reliability with an ICC of 0.85 . Internal consistency was strong ( Cronbach ’s alpha = 0.90 ) . Strong construct validity ( ICC values of 0.51–0.84 ) was obtained against the WOMAC and SF-36 ( physical functioning , role-physical , bodily pain , and social functioning subscales ) scores . Notable “ ceiling ” effects of the OKS were reported for 11 of the 12 question naire items . Conclusion The Japanese OKS has proven to be a reliable and valid instrument for the self- assessment of knee pain and function in Japanese speaking patients with knee OA and other knee complaints BACKGROUND Osteoarthritis is a degenerative disease associated with pain , reduced range of motion , and impaired function . Balneotherapy or bathing in thermal or mineral waters is used as a non-invasive treatment for various rheumatic diseases . AIM To evaluate the effectiveness of hot sulfurous and non-sulfurous waters in the treatment of  knee osteoarthritis  . DESIGN A r and omized , assessor-blind , controlled trial . SETTING A spa resort . POPULATION One hundred and forty patients of both genders , mean age of 64.8±8.9 years , with knee osteoarthritis and chronic knee pain . METHODS Patients were r and omized into three groups : the sulfurous water ( SW ) group ( N.=47 ) , non-sulfurous water ( NSW ) group ( N.=50 ) , or control group ( N.=43 ) who received no treatment . Patients were not blinded to treatment allocation . Treatment groups received 30 individual thermal baths ( three 20-minute baths a week for 10 weeks ) at 37 - 39 ° C . The outcome measures were pain ( visual analog scale , VAS ) , physical function ( Western Ontario and McMaster Universities Osteoarthritis Index , WOMAC ; Lequesne Algofunctional Index , LAFI ; Stanford Health Assessment Question naire , HAQ ) , and use of pain medication . Patients were assessed before treatment ( T1 ) , at treatment endpoint ( T2 ) , and two months post-intervention ( T3 ) . Intra- and intergroup comparisons were performed at a significance level of 0.05 ( P<0.05 ) . RESULTS A significant decrease in VAS pain scores ( pain during movement , at rest , and at night ) and use of pain medication , and improvement in WOMAC , LAFI and HAQ scores were observed from baseline to T2 and T3 within treatment groups ( P<0.001 ) , and between controls and both treatment groups at T2 and T3 ( P<0.001 ) . No significant differences in these variables were observed between treatment groups at T2 , but patients in the SW group reported less pain and better functional status than those in the NSW group at T3 , showing a lasting effect of sulfurous water baths . CONCLUSIONS Both therapeutic methods were effective in the treatment of knee osteoarthritis ; however , sulfurous baths yielded longer-lasting effects than non-sulfurous water baths . CLINICAL REHABILITATION IMPACT Baths in thermal waters , especially those in sulfurous waters , are effective in reducing pain and improving physical function in patients with knee osteoarthritis We have developed a 12-item question naire for patients having a total knee replacement ( TKR ) . We made a prospect i ve study of 117 patients before operation and at follow-up six months later , asking them to complete the new question naire and the form SF36 . Some also filled in the Stanford Health Assessment Question naire ( HAQ ) . An orthopaedic surgeon completed the American Knee Society ( AKS ) clinical score . The single score derived from the new question naire had high internal consistency , and its reproducibility , examined by test-retest reliability , was found to be satisfactory . Its validity was established by obtaining significant correlations in the expected direction with the AKS scores and the relevant parts of the SF36 and HAQ . Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at follow-up . We also compared change in scores with the patients ' retrospective judgement of change in their condition . The effect size for the new question naire compared favourably with those for the relevant parts of the SF36 . The change scores for the new knee question naire were significantly greater ( p < 0.0001 ) for patients who reported the most improvement in their condition . The new question naire provides a measure of outcome for TKR that is short , practical , reliable , valid and sensitive to clinical ly important changes over time Background The Hospital Anxiety and Depression Scale ( HADS ) is a common screening instrument excluding somatic symptoms of depression and anxiety , but previous studies have reported inconsistencies of its factor structure . The construct validity of the Japanese version of the HADS has yet to be reported . To examine the factor structure of the HADS in a Japanese population is needed . Methods Exploratory and confirmatory factor analyses were conducted in the combined data of 408 psychiatric out patients and 1069 undergraduate students . The data pool was r and omly split in half for a cross validation . An exploratory factor analysis was performed on one half of the data , and the fitness of the plausible model was examined in the other half of the data using a confirmatory factor analysis . Simultaneous multi-group analyses between the subgroups ( out patients vs. students , and men vs. women ) were subsequently conducted . Results A two-factor model where items 6 and 7 had dual loadings was supported . These factors were interpreted as reflecting anxiety and depression . Item 10 showed low contributions to both of the factors . Simultaneous multi-group analyses indicated a factor pattern stability across the subgroups . Conclusion The Japanese version of HADS indicated good factorial validity in our sample s. However , ambiguous wording of item 7 should be clarified in future revisions Objective The aim of this study was to compare whether the effectiveness of continuous ultrasound ( US ) was superior against pulsed US and against sham US in knee osteoarthritis . Design A r and omized controlled study was carried out on 60 patients diagnosed with knee osteoarthritis according to American College of Rheumatology . The patients were r and omized into the following three treatments : ( 1 ) continuous US ( at a frequency of 1 MHz with intensity of 1 W/cm2 ) , ( 2 ) pulse US ( same frequency and intensity on 1:4 pulse ratio ) , and ( 3 ) sham US . All treatments were applied with 5-cm2 head US device five times a week for 2 weeks in addition to home exercise program including quadriceps isometric exercise , muscle strength exercises , and stretching exercises of the lower extremity muscles for at least three times per week . Assessment s were performed at baseline , at the end of the treatment , and at the end of the treatments and at the sixth month using the following measurements : Western Ontario and McMaster University Osteoarthritis Index – pain , stiffness , function , visual analog scale – pain at rest , visual analog scale – pain on movement , visual analog scale – disease severity , and 20-m walking time . Among these parameters , the Western Ontario and McMaster University Osteoarthritis Index – pain was the primary outcome . Results All groups showed a significant improvement in all parameters in both following visits ( P < 0.05 ) . However , there was no significant difference between the groups . Although the mean reduction percent in Western Ontario and McMaster University Osteoarthritis Index – pain was significantly higher in group I ( continuous US ) when compared to sham group ( 46.5 % vs 28.9 % , P < 0.05 ) at the end of the treatment , this result was not found in other pain parameters . Conclusions The present study demonstrated that all assessment parameters significantly improved in all groups without a significant difference . This result suggested that therapeutic US provided no additional benefit in improving pain and functions in addition to exercise training BACKGROUND Knee osteoarthritis ( OA ) conservative treatment aims to delay cartilage degeneration ; chondroprotective agents are a valid approach in this sense . A commercially available dietary supplement , CartiJoint Forte , containing glucosamine hydrochloride ( GH ) , chondroitin sulfate ( CS ) and Bio-Curcumin BCM-95 ® , was used in this trial . AIM The aim of this study was to assess efficacy and safety of CartiJoint Forte combined with physical therapy in treating subjects with knee OA . DESIGN A multicenter , prospect i ve , r and omized , double blind , placebo-controlled clinical trial . SETTING Out patients referred to the Rehabilitation Departments of two University Hospitals . POPULATION Fifty-three patients were r and omly assigned to an experimental group ( N=26 ) or a control group ( N.=27 ) . Experimental subjects received two tablets of CartiJoint Forte each day for 8 weeks , while those in the control group were provided with a placebo . Three subjects dropped out during the course of the study . METHODS The two groups both received 20 sessions of physical therapy during the course of the trial . Primary outcome was pain intensity , measured both at motion and at rest , using the Visual Analogue Scale ( VAS ) . A secondary outcome was an assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and Lequesne Index , knee ROM , and two inflammation markers ( C-reactive protein and erythrocyte sedimentation rate ) . Each assessment was carried out at baseline ( T0 ) , at 8 weeks ( T1 ) and at 12 weeks ( T2 ) . RESULTS VAS at rest was found to be reduced between T0 and T1 , as well as between T0 and T2 ( F=13.712 ; P=0.0001 ) , with no differences between groups ( F=1.724 ; P=0.191 ) . VAS at motion revealed a significant " group × time-check " interaction ( F=2.491 ; P=0.032 ) , with increasing effect of time on VAS reduction ( F=17.748 ; P=0.0001 ) . This was most pronounced in the experimental group at 8 weeks ( F=3.437 ; P=0.045 ) . The Lequesne Index showed reductions at T1 and T2 compared to T0 ( F=9.535 ; P=0.0001 ) , along with group effect , since the experimental group presented a lower score at T2 ( F=7.091 ; P=0.009 ) . No significant changes were found in the knee ROM and inflammation markers .  CONCLUSION CartiJoint Forte , added to physical therapy , may ameliorate pain and help to improve algofunctional score in knee OA patients . CLINICAL REHABILITATION IMPACT Treatment of knee OA with curcuminoids plus glycosaminoglycans , added to physical therapy , improves VAS at motion and Lequesne Index scores 
    Output:
    