Heart failure and the cost of dying: must the ferryman always be paid?

BACKGROUND: Provision of palliative care in chronic heart failure (CHF) can support complex decision-making, significantly improve quality of life and may lower healthcare costs. AIMS: To examine whether healthcare costs differed in terminal admissions according to the adoption of a palliative approach. DESIGN: Retrospective review of medical records and costing data for all admissions resulting in death from CHF (July 2011 to December 2019), analysed as two groups (2011-2016 and 2016-2019) because of background changes in costings. SETTING: Admissions with CHF resulting in death in an Australian tertiary referral centre. RESULTS: The cohort (n = 439) were elderly (median age 83.7 years, interquartile range (IQR) = 77.6-88.7 years) and mostly men (54.9%). Half (230, 52.4%) were referred to a specialist palliative care team, whereas over a third (172, 39.2%) received a palliative approach. Receiving a palliative approach was associated with a nonstatistically significant lower admission cost (AU$12 710 vs AU$15 978; P = 0.19) between 2011 and 2016 (n = 101, 38.8%) and a significantly lower cost (AU$11 319 vs AU$15 978; P < 0.01) between 2016 and 2019 (n = 71, 39.7%). Intensive care admission resulted in the single greatest additional cost at AU$14 624 (IQR = AU$4130-AU$44 197) (n = 48, 2011-2016). Median terminal admission cost was lower for patients with comfort goals of care (P < 0.01), without life-sustaining interventions (P < 0.01) or who received a palliative approach (P < 0.01). Referral to inpatient specialist palliative care or receiving a palliative approach resulted in comparable admission costings (AU$11 621 [IQR = AU$4705-AU$32 457] and AU$11 466 [IQR = AU$4973-AU$25 614]). CONCLUSION: A palliative approach in terminal CHF admission may improve quality at the end of life and decrease costs associated with care.

Pre-operative predictors of post-operative falls in people undergoing total hip and knee replacement surgery: a prospective study.

INTRODUCTION: Pain and disability often persist following hip (THR) and knee replacement (TKR) surgery predisposing patients to increased risk of falling. This study identified pre-operative predictors for post-operative falls in TKR and THR patients, and the incidence and circumstances of falls in the 12 months post-surgery. MATERIALS AND METHODS: A survey was undertaken of patients before THR and TKR, and was repeated 12 months post-operation. The survey included (1) medical history and medications usage, (2) pain and function, (3) health-related and physical activity and (4) fear of falls and history of falls questionnaires. Patients were classified as 'fallers' (≥1 fall) or 'non-fallers' based on prospectively documented falls in the 12 months post-surgery. Binary logistic regression was conducted to identify independent pre-operative predictors of incident falls status. RESULTS: Eighty-two of the 243 participants (33.7%) reported ≥1 fall in the 12 months post-operatively [60 (34.1%) patients following TKR and 22 (32.8%) following THR]. The logistic regression model was statistically significant, χ 2 = 24.731, p < 0.001, the model explaining 22% of the variance in falls, and correctly classifying 73.7% of cases as fallers or non-fallers. Reduced SF-36v2 general health sub-scale, increased planned physical activity and previous falls in the preceding year were predictors of falls. Those reporting ≥1 fall pre-operatively were three times more likely to fall post-operatively. CONCLUSION: People awaiting hip or knee joint replacement surgery might present with complex conditions that predispose them to greater risk of falling post-operation. Review of general health and history of falling is recommended pre-operatively to identify patients at risk.

Development and validation of a questionnaire assessing discrepancy between patients' pre-surgery expectations and abilities and post-surgical outcomes following knee replacement surgery.

PURPOSE: The discrepancy between patient-desired outcomes and achievable functional outcomes is a source of patient dissatisfaction. This paper reports development and validation of a questionnaire to assess this discrepancy in patients undergoing knee replacement surgery. METHODS: The initial questionnaire (Knee Surgery Perception Questionnaire, KSPQ) comprised two parts. Part A, assessed patients' perception of their current level of function and pain, and Part B, assessed patients' desired outcomes of the surgery. Validation was carried out for Part A and then applied to Part B using a one-factor congeneric model and was tested in 185 patients preceding surgery. A discrepancy score between patients' expectations and desired outcome (Part B) and their perception of current function (Part A) was also calculated. Pearson correlations were used between the KSPQ total score and subscales and other knee-specific questionnaires to determine construct validity. RESULTS: The final best set of models included four items for each subscale with a Chi-square value of 7.3 (n.s). The subscales and the total KSPQ showed significant strong to moderate correlations with knee-specific questionnaires. The discrepancy score in each subscale and the overall score showed relatively large discrepancy between patients' expectations and their perception of current function; with higher discrepancy score reported for pain and walking. CONCLUSION: The KSPQ is a valid questionnaire to assess patients' expected and desired outcomes of knee replacement surgery and their perception of their current abilities and function, and discrepancy between these. The KSPQ now requires further investigation at different stages of recovery following surgery. LEVEL OF EVIDENCE: III.

Lower limb proprioception deficits persist following knee replacement surgery despite improvements in knee extension strength.

PURPOSE: Knee pain and disability can persist following knee replacement surgery which may place patients at increased risk of falls. This study investigated the falls risk and the occurrence of falls of people with knee osteoarthritis (OA) before and at 12 months following knee replacement surgery. METHOD: Thirty-five patients with knee OA were tested prior to undergoing knee replacement surgery and at 12 months following surgery using the short form Physiological Profile Assessment, which incorporates tests of vision, lower limb proprioception, knee extension strength, reaction time and postural sway. Physical activity, number of falls, fear of falling, pain, disability and health-related quality of life were also assessed. RESULTS: No significant differences were found between the number of falls pre- and post-surgery (n.s.), with 48.5 and 40% reporting at least one fall in the 12 months before and following the surgery, respectively. Improvements in knee strength, reaction time and fear of falling were evident following surgery, with no improvement in lower limb proprioception. Self-reported pain, function and stiffness were significantly improved, but health-related quality of life deteriorated following the surgery. CONCLUSION: The number of falls experienced following knee replacement surgery remained relatively high, which may be attributed to the persistence of impaired lower limb proprioception. Although knee replacement surgery improves function and alleviates pain, people who undergo this procedure may need to engage in rehabilitation following the surgery to reduce the risk of falling. LEVEL OF EVIDENCE: Therapeutic study investigating the result of treatment on patient outcomes, Level IV.

Impaired joint proprioception at higher shoulder elevations in chronic rotator cuff pathology.

OBJECTIVES: To assess the degree of impairment of shoulder proprioceptive acuity in individuals with chronic rotator cuff pathology (CRCP), and to examine the effect of impingement-related shoulder pain on acuity using a reliable laboratory technique. DESIGN: Case-control study. SETTING: University human movement laboratory. PARTICIPANTS: A volunteer sample of individuals with CRCP (n=26) were recruited and screened, and compared with age-, sex-, and limb dominance-matched individuals (n=30) who acted as controls. Ten participants with CRCP underwent repeat assessment after 2 days to determine the intrarater reliability of proprioceptive measurement. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Each participant underwent assessment of joint position sense at 40° and 100° of scapular plane abduction using an active position-matching task. Movements were recorded with reflective skin markers and a multidimensional motion analysis system. Self-reported pain intensity associated with the procedure was recorded with a visual analog scale. RESULTS: Intraclass correlation coefficients (model 3,5) between repeat assessments ranged from .54 to .99. On average, those with CRCP demonstrated reduced acuity at 40° and 100° test angles. In comparison with the control group, proprioceptive acuity was significantly impaired (P<.01) at the 100° test angle, where the pain intensity was significantly greater (P<.01). CONCLUSIONS: This study demonstrated impairment of shoulder joint position sense in CRCP. The degree of proprioceptive impairment was greatest at higher elevations in the setting of increased shoulder impingement and pain, which may serve to perpetuate the pathology. These findings provide a theoretic rationale for the continued implementation of proprioceptive rehabilitation programs in managing CRCP.

Foot and ankle strength, range of motion, posture, and deformity are associated with balance and functional ability in older adults.

OBJECTIVE: To determine the extent to which measures of foot and ankle strength, range of motion, posture, and deformity are associated with performance in a battery of balance and functional ability tests in older adults. DESIGN: Cross-sectional study of people over 65 years. SETTING: Community. PARTICIPANTS: Participants (N=305; age range, 65-93y) recruited for a randomized trial investigating the efficacy of a podiatry intervention to prevent falls. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Clinical measures of foot and ankle strength (using hand-held dynamometry), range of motion, posture, and deformity, and a battery of balance tests (postural sway, maximum balance range, lateral stability, coordinated stability) and functional ability tests (alternate step test, sit-to-stand, timed 6-m walk). RESULTS: Most (67/88) of the correlations between the foot and ankle tests and performance on the balance and functional tests were statistically significant. Hierarchic linear regression analysis identified hallux plantar flexion strength and ankle inversion-eversion range of motion to be the most consistent significant and independent predictors of balance and functional test performance, explaining up to 25% of the variance in the test scores. CONCLUSIONS: Foot and ankle characteristics, particularly plantar flexor strength of the hallux and ankle inversion-eversion range of motion, are important determinants of balance and functional ability in older people. Further research is required to establish whether intervention programs that include strengthening and stretching exercises for the foot and ankle may achieve improvements in balance and functional ability and reduce the risk of falls in older people.

Predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people.

BACKGROUND: Despite emerging evidence that foot problems and inappropriate footwear increase the risk of falls, there is little evidence as to whether foot-related intervention strategies can be successfully implemented. The aim of this study was to evaluate adherence rates, barriers to adherence, and the predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people. METHODS: The intervention group (n = 153, mean age 74.2 years) of a randomised trial that investigated the effectiveness of a multifaceted podiatry intervention to prevent falls was assessed for adherence to the three components of the intervention: (i) foot orthoses, (ii) footwear advice and footwear cost subsidy, and (iii) a home-based foot and ankle exercise program. Adherence to each component and the barriers to adherence were documented, and separate discriminant function analyses were undertaken to identify factors that were significantly and independently associated with adherence to the three intervention components. RESULTS: Adherence to the three components of the intervention was as follows: foot orthoses (69%), footwear (54%) and home-based exercise (72%). Discriminant function analyses identified that being younger was the best predictor of orthoses use, higher physical health status and lower fear of falling were independent predictors of footwear adherence, and higher physical health status was the best predictor of exercise adherence. The predictive accuracy of these models was only modest, with 62 to 71% of participants correctly classified. CONCLUSIONS: Adherence to a multifaceted podiatry intervention in this trial ranged from 54 to 72%. People with better physical health, less fear of falling and a younger age exhibited greater adherence, suggesting that strategies need to be developed to enhance adherence in frailer older people who are most at risk of falling. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12608000065392.

Physiological risk factors for falls in people with knee osteoarthritis before and early after knee replacement surgery.

PURPOSE: Knee osteoarthritis (OA) is a major cause of disability and a risk factor for falls in older people. The purpose of this study was to assess the falls risk of people with knee OA before surgery and at 4 months following surgery and to compare this to a control group. METHODS: Thirty-five patients with knee OA prior to undergoing knee replacement surgery and 27 asymptomatic age-matched controls participated in the study. The surgical group were tested prior to their surgery and at 4 months post-surgery. The short form of the Physiological Profile Assessment was used to assess falls risk and included tests of vision, lower limb proprioception, knee extension strength, reaction time and postural sway. Physical activity, quality of life, fear of falls and disability before and after surgery were also documented. RESULTS: At least one fall in the previous 12 months was reported for 48% of the surgical group compared with 30% of the control group. Following the surgery, there was a reduction in fear of falling and pain, and improvements in function for the surgical group. However, compared to the control group, the surgical group exhibited a greater fear of falling and reduced lower limb proprioception and knee extension strength both pre- and post-surgery. CONCLUSION: People who undergo knee replacement surgery may be at increased risk of falls both prior to and 4 months following their surgery, primarily due to deficits in knee extension strength and lower limb proprioception. Therefore, interventions to reduce the risk of falls should be implemented early after the surgery.

Validity of self-assessment of hallux valgus using the Manchester scale.

BACKGROUND: Hallux valgus (HV) is a common condition involving the progressive subluxation of the first metatarsophalangeal joint due to lateral deviation of the hallux and medial deviation of the first metatarsal. The objective of this study was to evaluate the re-test reliability and validity of self-assessment of HV using a simple clinical screening tool involving four standardised photographs (the Manchester scale), in order to determine whether this tool could be used for postal surveys of the condition. METHODS: HV was assessed with the Manchester scale in 138 people aged 65 to 93 years of age (102 women and 36 men) as part of a larger randomised controlled trial. At the six month follow-up assessment, HV was reassessed to determine re-test reliability, and participants were asked to self-assess their degree of HV independent of the examiners. Associations between (i) baseline and follow-up assessments of the examiners and (ii) participant and examiner assessments were performed using weighted kappa statistics. Analyses were then repeated after HV was dichotomised as present or absent using unweighted kappa, and sensitivity and specificity of self-assessment of HV was determined. RESULTS: Re-test reliability of the examiners was substantial to almost perfect (weighted kappa = 0.78 to 0.90), and there was a substantial level of agreement between observations of the participants and the examiners (weighted kappa = 0.71 to 0.80). Overall, there was a slight tendency for participants to rate their HV as less severe than the examiners. When the Manchester scale scores were dichotomised, agreement was substantial to almost perfect for both re-test comparisons (kappa = 0.80 to 0.89) and substantial for comparisons between participants and examiners (kappa = 0.64 to 0.76). The sensitivity and specificity of self-assessment of HV using the dichotomous scale were 85 and 88%, respectively. CONCLUSIONS: The Manchester scale demonstrates high re-test reliability, and self-assessment scores obtained by participants are strongly associated with scores obtained by examiners. These findings indicate that the tool can be used with confidence in postal surveys to document the presence and severity of HV. TRIAL REGISTRATION: ACTRN12608000065392.

Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: a protocol for a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Chronic rotator cuff pathology (CRCP) is a common shoulder condition causing pain and disability. Physiotherapy is often the first line of management for CRCP yet there is little conclusive evidence to support or refute its effectiveness and no formal evaluation of its cost-effectiveness. METHODS/DESIGN: This randomised, double-blind, placebo-controlled trial will involve 200 participants with CRCP recruited from medical practices, outpatient departments and the community via print and radio media. Participants will be randomly allocated to a physiotherapy or placebo group using concealed allocation stratified by treating physiotherapist. Both groups will receive 10 sessions of individual standardised treatment over 10 weeks from one of 10 project physiotherapists. For the following 12 weeks, the physiotherapy group will continue a home exercise program and the placebo group will receive no treatment. The physiotherapy program will comprise shoulder joint and spinal mobilisation, soft tissue massage, postural taping, and home exercises for scapular control, posture and rotator cuff strengthening. The placebo group will receive inactive ultrasound and gentle application of an inert gel over the shoulder region. Blinded assessment will be conducted at baseline and at 10 weeks and 22 weeks after randomisation. The primary outcome measures are self reported questionnaires including the shoulder pain and disability index (SPADI), average pain on an 11-point numeric rating scale and participant perceived global rating of change. Secondary measures include Medical Outcomes Study 36-item short form (SF-36), Assessment of Quality of Life index, numeric rating scales for shoulder pain and stiffness, participant perceived rating of change for pain, strength and stiffness, and manual muscle testing for shoulder strength using a handheld dynamometer. To evaluate cost-effectiveness, participants will record the use of all health-related treatments in a log-book returned to the assessor monthly. To test the effect of the intervention using an intention-to-treat analysis, linear regression modelling will be applied adjusting for baseline outcome values and other demographic characteristics. Participant measures of perceived change will be compared between groups by calculating the relative risks and their 95% confidence intervals at each time point using log binomial regression. DISCUSSION: Results from this trial will contribute to the evidence regarding the effectiveness of a physiotherapy program for the management of CRCP.

Effects of experimentally-induced anterior knee pain on knee joint position sense in healthy individuals.

PURPOSE: The ability to sense the position of limb segments is a highly specialised proprioceptive function important for control of movement. Abnormal knee proprioception has been found in association with several musculoskeletal pathologies but whether nociceptive stimulation can produce these proprioceptive changes is unclear. This study evaluated the effect of experimentally induced knee pain on knee joint position sense (JPS) in healthy individuals. STUDY DESIGN: Repeated measures, within-subject design. METHODS: Knee JPS was tested in 16 individuals with no history of knee pathology under three experimental conditions: baseline control, a distraction task and knee pain induced by injection of hypertonic saline into the infrapatellar fat pad. Knee JPS was measured using active ipsilateral limb matching responses at 20 degrees and 60 degrees flexion whilst non-weightbearing (NWB) and 20 degrees flexion single leg stance. During the tasks, the subjective perception of distraction and severity of pain were measured using 11-point numerical rating scales. RESULTS: Knee JPS was not altered by acute knee pain in any of the positions tested. The distraction task resulted in poorer concentration, greater JPS absolute errors at 20 degrees NWB, and greater variability in errors during the WB tests. There were no significant correlations between levels of pain and changes in JPS errors. Changes in JPS with pain and distraction were inversely related to baseline knee JPS variable error in all test positions (r=-0.56 to -0.91) but less related to baseline absolute error. CONCLUSION: Knee JPS is reduced by an attention-demanding task but not by experimentally induced pain.

A community-based strength training programme increases muscle strength and physical activity in young people with Down syndrome: a randomised controlled trial.

This randomised controlled trial investigated the effects of a student-led progressive resistance training (PRT) programme in adolescents and young adults with Down syndrome. Sixty-eight young people with Down syndrome (30 female, 38 male; mean age 17.9±2.6 years) and mild to moderate intellectual disability were randomly allocated to a PRT programme (n=34) or a social group (n=34). Participants in the PRT group trained twice a week for 10 weeks at a community gymnasium with a physiotherapy student mentor using pin-loaded weight machines. Participants in the social group completed a 10-week programme of social activities also with a student mentor once a week for 90 min. Work performance, muscle strength and physical activity levels were assessed at weeks 0, 11 and 24 by an assessor blind to group allocation. Data were analysed using ANCOVA with baseline measures as covariate. Participants attended 92% of their scheduled sessions. There was no difference between the groups on work task performance. The PRT group increased their upper and lower limb strength at week 11 compared to the control group, but only their lower limb muscle strength at week 24. There was a significant difference in physical activity levels in favour of the PRT group at week 24 but not at week 11. PRT using a student mentor model helps young people with Down syndrome become stronger and more physically active but its effect on work task performance is unclear.

Visual categorisation of the arch index: a simplified measure of foot posture in older people.

BACKGROUND: Foot posture is considered to be an important component of musculoskeletal assessment in clinical practice and research. However, many measurement approaches are not suitable for routine use as they are time-consuming or require specialised equipment and/or clinical expertise. The objective of this study was therefore to develop and evaluate a simple visual tool for foot posture assessment based on the Arch Index (AI) that could be used in clinical and research settings. METHODS: Fully weightbearing footprints from 602 people aged 62 to 96 years were obtained using a carbon paper imprint material, and cut-off AI scores dividing participants into three categories (high, normal and low) were determined using the central limit theorem (i.e. normal = +/- 1 standard deviation from the mean). A visual tool was then created using representative examples for the boundaries of each category. Two examiners were then asked to use the tool to independently grade the footprints of 60 participants (20 for each of the three categories, randomly presented), and then repeat the process two weeks later. Inter- and intra-tester reliability was determined using Spearman's rho, percentage agreement and weighted kappa statistics. The validity of the examiner's assessments was evaluated by comparing their categorisations to the actual AI score using Spearman's rho and analysis of variance (ANOVA), and to the actual AI category using percentage agreement, Spearman's rho and weighted kappa. RESULTS: Inter- and intra-tester reliability of the examiners was almost perfect (percentage agreement = 93 to 97%; Spearman's rho = 0.91 to 0.95, and weighted kappas = 0.85 to 0.93). Examiner's scores were strongly correlated with actual AI values (Spearman's rho = 0.91 to 0.94 and significant differences between all categories with ANOVA; p < 0.001) and AI categories (percentage agreement = 95 to 98%; Spearman's rho = 0.89 to 0.94, and weighted kappas = 0.87 to 0.94). There was a slight tendency for examiners to categorise participants as having higher arches than their AI scores indicated. CONCLUSIONS: Foot posture can be quickly and reliably categorised as high, normal or low in older people using a simplified visual categorisation tool based on the AI.

Effects of exercise on bone density and falls risk factors in post-menopausal women with osteopenia: a randomised controlled trial.

OBJECTIVES: This study aimed to determine the efficacy of an exercise program for post-menopausal women with osteopenia undertaken in community exercise facilities. DESIGN: Randomised, single-blind controlled trial. METHODS: Thirty-nine community volunteers with hip osteopenia and not taking bone-enhancing medication were randomly allocated to an exercise (EX) or control (CON) group. EX participants attended an exercise facility in Melbourne, Australia, three times/week for 52 weeks (with a 2 week break) for partially supervised exercises targeting hip bone strength, muscle strength and balance. They also performed daily jumping exercises at home. CON participants continued with their usual care. All participants were given calcium supplementation. Assessment at baseline and 52 weeks measured bone mineral density (BMD) at the proximal femur and lumbar spine. Health-related quality of life (QOL) and objective measures of strength and balance were also collected. RESULTS: ANCOVA adjusting for baseline values revealed a small benefit of exercise in mean total hip BMD (the primary outcome) with a significant mean difference in change between groups of -0.012 g/cm(2) (95% CI -0.022 to -0.002 g/cm(2)). EX participants improved 0.5% compared with a 0.9% loss for CON participants. The only other between-group differences were in QOL and a test of trunk and upper limb endurance, which both favoured the EX group. CONCLUSIONS: This exercise program appears to have modest benefits for post-menopausal women with osteopenia who are not taking bone-enhancing medication. This mode of exercise delivery has adherence and progression limitations but may be appropriate to recommend for some people.

Effectiveness of a multifaceted podiatry intervention to prevent falls in community dwelling older people with disabling foot pain: randomised controlled trial.

OBJECTIVE: To determine the effectiveness of a multifaceted podiatry intervention in preventing falls in community dwelling older people with disabling foot pain. DESIGN: Parallel group randomised controlled trial. SETTING: University health sciences clinic in Melbourne, Australia. PARTICIPANTS: 305 community dwelling men and women (mean age 74 (SD 6) years) with disabling foot pain and an increased risk of falling. 153 were allocated to a multifaceted podiatry intervention and 152 to routine podiatry care, with 12 months' follow-up. INTERVENTIONS: Multifaceted podiatry intervention consisting of foot orthoses, advice on footwear, subsidy for footwear ($A100 voucher; £65; €74), a home based programme of foot and ankle exercises, a falls prevention education booklet, and routine podiatry care for 12 months. The control group received routine podiatry care for 12 months. MAIN OUTCOME MEASURES: Proportion of fallers and multiple fallers, falling rate, and injuries resulting from falls during follow-up. RESULTS: Overall, 264 falls occurred during the study. 296 participants returned all 12 calendars: 147 (96%) in the intervention group and 149 (98%) in the control group. Adherence was good, with 52% of the participants completing 75% or more of the requested three exercise sessions weekly, and 55% of those issued orthoses reporting wearing them most of the time. Participants in the intervention group (n=153) experienced 36% fewer falls than participants in the control group (incidence rate ratio 0.64, 95% confidence interval 0.45 to 0.91, P=0.01). The proportion of fallers and multiple fallers did not differ significantly between the groups (relative risk 0.85, 0.66 to 1.08, P=0.19 and 0.63, 0.38 to 1.04, P=0.07). One fracture occurred in the intervention group and seven in the control group (0.14, 0.02 to 1.15, P=0.07). Significant improvements in the intervention group compared with the control group were found for the domains of strength (ankle eversion), range of motion (ankle dorsiflexion and inversion/eversion), and balance (postural sway on the floor when barefoot and maximum balance range wearing shoes). CONCLUSIONS: A multifaceted podiatry intervention reduced the rate of falls in community dwelling older people with disabling foot pain. The components of the intervention are inexpensive and relatively simple to implement, suggesting that the programme could be incorporated into routine podiatry practice or multidisciplinary falls prevention clinics. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12608000065392.

Efficacy of standardised manual therapy and home exercise programme for chronic rotator cuff disease: randomised placebo controlled trial.

OBJECTIVE: To investigate the efficacy of a programme of manual therapy and exercise treatment compared with placebo treatment delivered by physiotherapists for people with chronic rotator cuff disease. DESIGN: Randomised, participant and single assessor blinded, placebo controlled trial. SETTING: Metropolitan region of Melbourne, Victoria, Australia. PARTICIPANTS: 120 participants with chronic (>3 months) rotator cuff disease recruited through medical practitioners and from the community. INTERVENTIONS: The active treatment comprised a manual therapy and home exercise programme; the placebo treatment comprised inactive ultrasound therapy and application of an inert gel. Participants in both groups received 10 sessions of individual standardised treatment over 10 weeks. For the following 12 weeks, the active group continued the home exercise programme and the placebo group received no treatment. MAIN OUTCOME MEASURES: The primary outcomes were pain and function measured by the shoulder pain and disability index, average pain on movement measured on an 11 point numerical rating scale, and participants' perceived global rating of overall change. RESULTS: 112 (93%) participants completed the 22 week trial. At 11 weeks no difference was found between groups for change in shoulder pain and disability index (3.6, 95% confidence interval -2.1 to 9.4) or change in pain (0.7, -0.1 to 1.5); both groups showed significant improvements. More participants in the active group reported a successful outcome (defined as "much better"), although the difference was not statistically significant: 42% (24/57) of active participants and 30% (18/61) of placebo participants (relative risk 1.43, 0.87 to 2.34). The active group showed a significantly greater improvement in shoulder pain and disability index than did the placebo group at 22 weeks (between group difference 7.1, 0.3 to 13.9), although no significant difference existed between groups for change in pain (0.9, -0.03 to 1.7) or for the percentage of participants reporting a successful treatment outcome (relative risk 1.39, 0.94 to 2.03). Several secondary outcomes favoured the active group, including shoulder pain and disability index function score, muscle strength, interference with activity, and quality of life. CONCLUSION: A standardised programme of manual therapy and home exercise did not confer additional immediate benefits for pain and function compared with a realistic placebo treatment that controlled for therapists' contact in middle aged to older adults with chronic rotator cuff disease. However, greater improvements were apparent at follow-up, particularly in shoulder function and strength, suggesting that benefits with active treatment take longer to manifest. TRIAL REGISTRATION: Clinical trials NCT00415441.