title: Publication bias and clinical trials. Functional changes in patients with spondylarthropathy. A controlled trial of the effects of short-term rehabilitation and 3-year follow-up Exercise and changes in health status in patients with ankylosing spondylitis. A 3-year follow-up of temporomandibular disorders in rheumatoid arthritis and ankylosing spondylitis. Fifteen months' follow-up of intensive inpatient physiotherapy and exercise in ankylosing spondylitis The effects of comprehensive home physiotherapy and supervision on patients with ankylosing spondylitis--a randomized controlled trial. Cost effectiveness of group physical therapy compared to individualized therapy for ankylosing spondylitis. A randomized controlled trial. [Evaluation of the Amor criteria for spondylarthropathies and European Spondylarthropathy Study Group (ESSG). A cross-sectional analysis of 2,228 patients]. Continuation of group physical therapy is necessary in ankylosing spondylitis: results of a randomized controlled trial. The effects of comprehensive home physiotherapy and supervision on patients with ankylosing spondylitis--an 8-month followup. Physiotherapy in subtropic climate improves functional capacity and health‐related quality of life in Swedish patients with rheumatoid arthritis and spondylarthropathies still after 6 months The effect of a home based exercise intervention package on outcome in ankylosing spondylitis: a randomized controlled trial. Is group physical therapy superior to individualized therapy in ankylosing spondylitis? A randomized controlled trial. Cost effectiveness of combined spa-exercise therapy in ankylosing spondylitis: a randomized controlled trial. Home exercise and compliance in inflammatory rheumatic diseases--a prospective clinical trial. The effectiveness of intensive group exercise on patients with ankylosing spondylitis In-patient regime for the treatment of ankylosing spondylitis: an appraisal of improvement in spinal mobility and the effects of corticotrophin.
abstract: A study was performed to evaluate the extent to which the medical literature may be misleading as a result of selective publication of r and omized clinical trials ( RCTs ) with results showing a statistically significant treatment effect . Three hundred eighteen authors of published trials were asked whether they had participated in any unpublished RCTs .  The 156 respondents reported 271 unpublished and 1041 published trials . Of the 178 completed unpublished RCTs with a trend specified , 26 ( 14 % ) favored the new therapy compared to 423 of 767 ( 55 % ) published reports ( p less than 0.001 ) . For trials that were completed but not published , the major reasons for nonpublication were " negative " results and lack of interest . From the data provided , it appears that nonpublication was primarily a result of failure to write up and su bmi t the trial results rather than rejection of su bmi tted manuscripts . The results of this study imply the existence of a publication bias of importance both to meta- analysis and the interpretation of statistically significant positive trials Abstract . A cohort of 25 patients with spondylarthropathy ( SpA ) participated in a 3-year follow-up study of functional changes before and after an intensive 3-week inpatient course .  They answered questions in the following functional status/disability indices : Bath ankylosing spondylitis functional index ( BASFI ) , Dougados functional index ( DFI ) , health assessment question naire for spondylarthropathy ( HAQ-S ) , Bath ankylosing spondylitis disease activity index ( BASDAI ) , Bath ankylosing spondylitis patient global assessment ( BAS-G ) , and horizontal visual analogue scale for stiffness ( stiffness VAS ) before and after the course and 3 years later by mail . A control group of 18 consecutive SpA patients from the waiting list for an inpatient course filled in the same question naires as study patients 3 months before entry and again 3 weeks later at home without rehabilitation . During the waiting time for the inpatient course , control group global assessment s ( BASDAI , BAS-G , and stiffness-VAS ) worsened slightly , and BASFI but not HAQ-S and DFI scores remained unchanged in the 3 weeks without treatment . The results of the 25 study patients showed small and not significant improvements in all functional index scores ( BASFI –0.5 points , DFI –1.1 , and HAQ-S –0.17 ) , whereas improvements were significant in BASDAI , BAS-G , and stiffness-VAS ( –13 mm , –13 mm , and –11 mm , respectively ) after the 3-week inpatient course . At 3-year follow-up , these small changes had disappeared and the changes were not significant . The global indices and BASFI worsened slightly ( 0.4 ) from baseline results , while DFI was slightly better ( –0.4 ) and HAQ-S remained at the post-treatment level after 3 years . Thus , BASFI was the most sensitive to changes , whereas DFI and HAQ-S were relatively insensitive . All six indices correlated highly significantly with each other ( ICC 0.53–0.94 ) . The natural course of spondylarthropathy leads to progression of functional impairments , which seems to be preventable with intensive rehabilitation , at least in the short term . Among the three functional indices , BASFI seems to be the most sensitive tool BACKGROUND Although exercise is a commonly recommended treatment for ankylosing spondylitis ( AS ) , little is known about the effectiveness of unsupervised recreational and back exercises . We examined the effects of recreational exercise and back exercises on  patient-reported pain severity , stiffness severity , and functional disability  in a prospect i ve longitudinal study of 220 patients with AS . METHODS Participants provided information on exercise habits and health status every 6 months using mailed question naires ( median follow-up , 4.5 years ) . Pain severity and stiffness severity were measured using visual analog scales , and functional disability was measured using the Health Assessment Question naire ( HAQ ) Disability Index . RESULTS Among all patients , there were no associations between either the number of exercise minutes per week or the number of days of back exercise per week and short-term ( 6-month ) changes in pain , stiffness , or HAQ Disability Index . However , among those who had AS for 15 years or less , pain scores were 0.18 points lower ( on a scale of 0 - 3 ; P = .04 ) , and stiffness scores were 6.4 points lower ( on a scale of 0 - 100 ; P = .005 ) during periods with more than 200 minutes per week of exercise compared with periods with 0 to 30 minutes of exercise per week . Among those who had AS for more than 15 years , pain scores were 0.11 points lower ( on a scale of 0 - 3 ; P = . 03 ) , and HAQ Disability Indexes were 0.08 points lower ( on a scale of 0 - 3 ; P<.001 ) during periods with 5 to 7 days per week of back exercise compared with periods when back exercises were not performed . Less intense levels of exercise were not associated with improvements in health status . CONCLUSIONS Unsupervised recreational exercise improves pain and stiffness , and back exercise improves pain and function in patients with AS , but these effects differ with the duration of AS . Health status is improved when patients perform recreational exercise at least 30 minutes per day and back exercises at least 5 days per week . Arch Intern Med . 2000;160:2969 - Sixteen individuals with rheumatoid arthritis ( RA ) and 19 individuals with ankylosing spondylitis ( AS ) participated in this 3-year follow-up study . The individuals in each disease group were allocated to an experimental group ( E group ) and a comparison group ( C group ) . They were investigated by question naire , clinical examination of the stomatognathic system , and laboratory tests . The individuals of the two E groups had performed a physical training program of the stomatognathic system during 3 weeks . After 3 years most of the patients in the E groups reported an unaltered or decreased severity of symptoms and signs from the stomatognathic system compared with the initial status . The clinical dysfunction score according to Helkimo ( CDS ) was lower in the RA group , and the mouth opening capacity was larger than before training . In the AS group there was no long-term change in the CDS but an increase of mouth opening capacity . The general inflammatory disease process in the RA group showed an increased activity during this follow-up period as assessed by erythrocyte sedimentation rate . This study suggests that local physical training of the stomatognathic system has a positive effect in individuals with RA Summary Long-term effects of three or four-week inpatient physiotherapy and exercise courses were studied in 141 adult patients with ankylosing spondylitis ( AS ) . Eight cervical and thoracolumbar range of motion ( ROM ) measurements and straight leg raise test , vital capacity ( VC ) and fitness index were measured at the beginning and end of an intensive course and 15 months later . All nine mobility measurements , vital capacity and fitness index were significantly improved after the course . Fifteen months later only chest expansion and vital capacity had significantly deteriorated from the baseline , while CR , FFD and fitness index were still significantly better . Disease duration did not influence treatment results .We conclude that it is possible by means of intensive rehabilitation courses to prevent for more than one year deterioration of spinal function and fitness in AS patients irrespective of disease duration Fifty-three patients with ankylosing spondylitis ( AS ) were r and omly allocated ; 26 experimental patients received physiotherapy and disease education , 27 control patients received neither . The primary treatment outcome was change in spinal mobility measured at 4 months by fingertip-to-floor distance . Experimental patients had more improvement in fingertip-to-floor distance ( p2 less than 0.004 ) and in function ( p2 less than 0.001 ) than control patients . Physiotherapy with disease education is effective in the treatment of patients with AS OBJECTIVE Cost effectiveness analysis is helpful in setting priorities for funding of health care programs . We studied the cost effectiveness of supervised group physical therapy compared to unsupervised exercises at home in patients with ankylosing spondylitis ( AS ) . METHODS A total of 144 patients with AS ( modified New York criteria ; mean age : 43 years ) were r and omized to unsupervised daily individualized exercises at home for 9 months or the same plus supervised group physical therapy ( 3 h weekly ) . At baseline and after 9 months we measured spinal mobility ( thoracolumbar flexion and extension ) , fitness ( maximum work capacity by ergometry ) , and patient 's global assessment of change as measured on a visual analog scale . We used a question naire at baseline and a diary during the trial to measure AS related direct medical costs , such as doctor visits , paramedical treatment , medication and hospitalization . RESULTS The mean effects of group therapy and home exercises were , respectively , + 0.9 cm ( 16 % ) and + 0.5 cm ( 9 % ) for mobility , + 7 watts ( 4 % ) and -2 watts ( -1 % ) for fitness , and + 1.7 ( 34 % ) and + 0.3 ( 6 % ) for global health . These 3 differences were significant ( p < 0.01 for mobility , p = 0.05 for fitness and p < 0.01 for global health ) . During the trial total medical costs decreased by an average of US $ 379 ( 44 % ) for group therapy , and by $ 257 (35%)/patient/year for the " home " group . Additional costs of group therapy were estimated at $ 531/patient/year ( $ 177 for accommodation , $ 256 for therapist and $ 98 for material s ) . After the study 75 % of the patients wanted to continue group physical therapy and were willing to pay for it . CONCLUSION Compared to therapy at home , additional benefits of group therapy cost $ 531/year , but reduced direct medical costs by $ 122/year . Hence , the beneficial effects of group therapy cost $ 409/patient with AS/year Two sets of criteria have been proposed to discriminate spondylarthropathies ( SA ) from other rheumatic diseases . To evaluate their performance , we conducted a cross-sectional study in the patients observed during one week in 28 French Departments of Rheumatology by 91 staff-teaching physicians . The physicians had to apply these criteria to all their patients and had to classify them as definite SA , definite other rheumatic disease or possible SA . The analysis performed on the 2,088 patients with a definite diagnosis ( 124 SA and 1,964 controls ) showed the following results : ( table ; see text ) Of the 140 patients with possible SA , 37 fulfilled both sets of criteria , 22 the ESSG criteria alone and 12 the Amor criteria alone . These data suggest that a ) the overall performance of these two sets of criteria is similar ; b ) this performance is better in the group of patients with a definite diagnosis ; c ) the patients without a definite diagnosis require a longer follow-up to assess the clinical relevance of these two sets of criteria PURPOSE Group physical therapy in patients with ankylosing spondylitis was studied to determine whether beneficial effects persisted after cessation of the intervention . METHODS After a 9-month period of supervised group physical therapy , 68 patients were r and omized for another 9 months to unsupervised daily exercises at home ( discontinuation group ) or continuation of weekly sessions of supervised group physical therapy ( continuation group ) . Endpoints were spinal mobility ( thoraco-lumbar flexion and extension , chest expansion , cervical rotation ) , fitness ( maximum work capacity ) , functioning ( Sickness Impact Profile ( SIP ) , Health Assessment Question naire for the Spondylarthropathies [ HAQ-S ] , Functional Index [ FI ] ) , and patient 's global health assessment on a visual analogue scale . RESULTS Time for exercises at home was significantly higher in the continuation than in the discontinuation group ( mean duration 1.9 versus 1.2 hr per week , P < 0.05 ) . The continuation group improved in global health ( mean improvement 1.6 ; 32 % ) and in SIP score . Scores for thoraco-lumbar mobility and HAQ-S did not change very much , whereas chest expansion , cervical rotation , fitness , and FI deteriorated . The average attendance for group therapy sessions was 62 % . The discontinuation group improved only marginally ( 0.2 ; 4 % ) in global health , whereas all other endpoints decreased . Only for global health and HAQ-S were the differences statistically significant in favor of the continuation group . CONCLUSIONS Global health and functioning are sustained or even improved further if group physical therapy is continued . Spinal mobility decreased slightly in both groups OBJECTIVE Our previous r and omized clinical trial showed a 4-month home physiotherapy program was effective for patients with ankylosing spondylitis . This followup study reports on 22 control patients who received the previously withheld treatment and 24 experimental patients who received followup treatment as needed . METHODS The primary outcome measure was spinal mobility measured by fingertip-to-floor distance using a portable measuring device specially design ed and vali date d for this study . RESULTS Following treatment , fingertip-to-floor distance did not change in control patients ( P2 = 0.145 ) . Between 4 and 8 months , fingertip-to-floor distance did not change in experimental patients ( P2 = 0.143 ) ; however , initial improvement achieved was maintained . The experimental group at 4 months was better than the control group at 8 months ( P2 = 0.038 ) . CONCLUSION The home physiotherapy treatment program must be delivered as rigorously as it was in the initial trial to be effective . The benefit from this treatment program can be maintained with very little intervention Objective : The objective was to prospect ively evaluate the short as well as the long‐term effects of intensive physiotherapy in a stable , sunny and warm climate on physical function and health related quality of life in patients with rheumatoid arthritis ( RA ) and spondylarthropathies ( SpA ) . Methods : Ninety‐three Swedish patients with RA and SpA receiving physiotherapy for 4 weeks in Israel or Tenerife were followed for 6 months . Physical function was evaluated by the Swedish version of Stanford Health Assessment Question naire ( HAQ ) and quality of life by the  Nottingham Health Profile ( NHP )  question naire . Results : There were significant improvements in HAQ‐scores and global NHP‐scores as well as all subcategories of NHP immediately after the treatment abroad , effects that were still measurable after six months . At that time point nearly half of the patients had clinical ly meaningful reduction of HAQ‐scores ( ≥0.25 ) . Conclusion : Physiotherapy in a warm and stable climate , with many hours of daily sunshine , is a valuable treatment complement for Swedish patients with RA and OBJECTIVE Home based self-care is essential for successful management of ankylosing spondylitis ( AS ) . We design ed an intervention package aim ed at promoting self-care and regular longterm exercise and evaluated its effect on outcome . METHOD Members of our data base ( n = 4569 ) were r and omly selected and r and omized to an intervention group ( IG ) or a followup control group ( CG ) . The intervention consisted of an exercise/information video , exercise progress chart , patient education booklet , and AS exercise reminder stickers . The outcome measures were function ( BASFI ) , disease activity ( BASDAI ) , global well being ( BAS-G ) , exercise self-efficacy ( ESE ) , arthritis self-efficacy ( SES ) , and quantity of AS mobility/aerobic exercise assessed at baseline and 6 months . RESULTS Of the 200 subjects , 155 completed the study ( 75 IG and 80 CG ) . Baseline analysis showed no differences between the CG and the IG . At 6 months , analysis revealed no statistically significant between-group differences for the BASFI , BASDAI , and BAS-G. although the p value of 0.08 for function approached significance . Self-efficacy for exercise showed a significant improvement in the IG ( p = 0.045 ) . There were no between-group differences for the SES pain and other symptoms subscales . Finally , there was a significant increase in self-reported AS mobility ( p < 0.001 ) and aerobic exercise ( p < 0.05 ) in the IG . CONCLUSION An exercise intervention package design ed to promote self-management in AS ( 1 ) significantly improves self-efficacy for exercise ; ( 2 ) significantly improves self-reported levels of exercise ; ( 3 ) reveals a trend for improvement in function ( BASFI ) PURPOSE To study the effects of adding supervised group physical therapy to unsupervised individualized therapy in ankylosing spondylitis . METHODS One hundred forty-four patients were  r and omized to exercises at home , or the same plus weekly group physical therapy for 9 months . Endpoints were spinal mobility , fitness ( maximum work capacity by ergometry ) , functioning ( Sickness Impact Profile , Health Assessment Question naire for the Spondylarthropathies , and Functional Index ) , and patient 's global assessment of change on a 10-cm visual analogue scale . RESULTS Thoracolumbar flexion and extension increased by an average of 0.5 cm ( 9 % ) after home exercises , and by 0.9 cm ( 16 % ) after group therapy . Maximum load in ergometry decreased by 2 W ( 1 % ) after home exercises , but increased by 7 W ( 4 % ) after group therapy . Global assessment improved by 0.3 ( 6 % ) after home exercises , and by 1.7 ( 34 % ) after group therapy . These three differences were statistically significant . There were no significant differences in chest expansion , cervical rotation , or the self- assessment s of functioning . CONCLUSIONS Group physical therapy proved superior to individualized therapy in improving thoracolumbar mobility and fitness , and had an important effect on global health reported by the patients OBJECTIVE To evaluate the cost effectiveness and cost utility of a 3-week course of combined spa therapy and exercise therapy in addition to st and ard treatment consisting of antiinflammatory drugs and weekly group physical therapy in ankylosing spondylitis ( AS ) patients . METHODS A total of 120 Dutch out patients with AS were r and omly allocated into 3 groups of 40 patients each . Group 1 was treated in a  spa resort in Bad Hofgastein , Austria ; group 2 in a spa resort in Arcen , The Netherl and s. The control group stayed at home and continued their usual activities and st and ard treatment during the intervention weeks . After the intervention , all patients followed weekly group physical therapy . The total study period was 40 weeks . Effectiveness of the intervention was assessed by functional ability using the Bath Ankylosing Spondylitis Function Index ( BASFI ) . Utilities were measured with the EuroQoL ( EQ-5D(utility ) ) . A time-integrated summary score defined the clinical effects ( BASFI-area under the curve [ AUC ] ) and utilities ( EQ-5D(utility)-AUC ) over time . Both direct ( health care and non-health care ) and indirect costs were included . Re source utilization and absence from work were registered weekly by the patients in a diary . All costs were calculated from a societal perspective . RESULTS A total of 111 patients completed the diary . The between-group difference for the BASFI-AUC was 1.0 ( 95 % confidence interval [ 95 % CI ] 0.4 - 1.6 ; P = 0.001 ) for group 1 versus controls , and 0.6 ( 95 % CI 0.1 - 1.1 ; P = 0.020 ) for group 2 versus controls . The between-group difference for EQ-5D(utility)-AUC was 0.17 ( 95 % CI 0.09 - 0.25 ; P < 0.001 ) for group 1 versus controls , and 0.08 ( 95 % CI 0.00 - 0.15 ; P = 0.04 ) for group 2 versus controls . The mean total costs per patient ( including costs for spa therapy ) in Euros ( euro ; ) during the study period were euro;3,023 for group 1 , euro;3,240 for group 2 , and euro;1,754 for the control group . The incremental cost-effectiveness ratio per unit effect gained in functional ability ( 0 - 10 scale ) was euro;1,269 ( 95 % CI 497 - 3,316 ) for group 1 , and euro;2,477 ( 95 % CI 601 - 12,098 ) for group 2 . The costs per quality -adjusted life year gained were euro;7,465 ( 95 % CI 3,294 - 14,686 ) for group 1 , and euro;18,575 ( 95 % CI 3,678 - 114,257 ) for group 2 . CONCLUSION Combined spa-exercise therapy besides st and ard treatment with drugs and weekly group physical therapy is more effective and shows favorable cost-effectiveness and cost-utility ratios compared with st and ard treatment alone in patients with AS OBJECTIVE To survey and to compare the one year effects of dynamic muscle training and progressive muscle relaxation as home exercise for patients with inflammatory rheumatic diseases ; and to identify predictors for compliance with a longterm home exercise regimen . METHODS Fifty-four patients ( mean age 54 yrs , mean symptom duration 14 yrs ) were assessed for health related quality of life , exercise motivation , joint tenderness , and physical capacities .  After r and omization into 2 groups , every patient was instructed on one occasion in a 30 min program of either dynamic training or muscle relaxation to carry out at home , 5 times a week during 3 months , and then 2 - 3 times a week for another 9 months . RESULTS Seventeen patients in each group completed the one year exercise protocol , while 10 from each group did not . Compliance with the one year exercise regimen seemed to be predicted by high self-efficacy for exercise , regular range-of-motion exercises before the intervention , and being unmarried . After one year , minor improvements in physical effect ( p < or = 0.05 ) and work effect ( p < or = 0.05 ) were found in the dynamic training group , while minor improvements in pain effect ( p < or = 0.05 ) , emotional reactions ( p < or = 0.05 ) , and arm endurance ( p < or = 0.01 ) were found in the muscle relaxation group . No differences between the groups regarding changes in health status , joint tenderness , or physical capacities during the intervention period were found . CONCLUSION These results may improve the selection of patients for home exercise , and form a basis for improved administration of home exercise programs Objective : To compare , in patients with ankylosing spondylitis ( AS ) , the effectiveness on pain , functional and psychological status of an intensive group exercise programme under the supervision of a physiotherapist and a home physiotherapy programme . Design : Fifty-one patients with AS were r and omly allocated into study and control groups . The study was design ed as a prospect i ve , double-blind study . Setting : Outpatient department , Istanbul Medical Faculty . Subjects : Patients who consulted with complaints of pain , morning stiffness and restricted range of movement with a confirmed diagnosis of ankylosing spondylitis . Interventions : Before exercise , both groups were given an education programme about AS . For group I patients an intensive exercise programme was organized under the supervision of a physiotherapist for six weeks . Group II patients had to practise exercises individually at home . Main outcome measures : Both groups were evaluated and compared for pain , functional and psychological status before treatment , at the end of treatment and three months after treatment using a visual analogue scale ( VAS ) for pain , Beck Depression Scale and Bath Ankylosing Spondylitis Functional Index ( BASFI ) . Results : Six patients withdrew , four from group I. Results from the remaining 45 showed more positive changes in the patients undertaking group exercise at six weeks and three months after treatment . Values showed a statistical significant difference in favour of group I. Conclusion : Group exercise in hospital may be more effective than home-based exercises at reducing impairment associated with ankylosing spondylitis Twenty-one patients with ankylosing spondylitis were admitted for two weeks bedrest , postural and mobilizing exercises . Eleven received low-dose corticotrophin and 10 received placebo injections during their admission and all were review ed after two months . In-patient therapy result ed in significant improvements in function , early morning stiffness , spinal pain , lumbar extension and lateral flexion , finger-floor distance and wall-tragus distance . These improvements were maintained at two months . Biplanar radiography confirmed significant improvements of lumbar spine mobility in 14 male subjects studied . Less improvement occurred in neck movements and these were not maintained . There were no differences between the two treatment groups
target: There is not sufficient evidence yet available to base recommendations for or against the use of physiotherapy interventions for ankylosing spondylitis
background: BACKGROUND Ankylosing spondylitis ( AS ) is a chronic rheumatic disease .
  Due to the consequences of the disease , physiotherapy is regarded to be an important part of the treatment .
  OBJECTIVES The objective is to summarise the available scientific evidence on the effectiveness of physiotherapy interventions in the management of AS .