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Objectives To determine whether physiotherapist-led exercise intervention and US-guided subacromial CS injection is cost-effective when compared with standard advice and exercise leaflet and unguided injection in patients with subacromial pain (impingement) syndrome. Methods An incremental cost–utility analysis using patient responses to the five-level EuroQoL-5D (EQ-5D-5L) questionnaire was undertaken from a healthcare perspective alongside a 2 × 2 factorial randomized trial with 256 participants over a 12-month follow-up period. Uncertainty was explored through the use of cost-effectiveness acceptability curves. Results The cost–utility analysis indicated that physiotherapist-led exercise was associated with an incremental cost of £155.99 (95% CI 69.02, 241.93) and 0.031 (95% CI −0.01, 0.07) additional quality-adjusted life-years (QALYs), an incremental cost-effectiveness ratio (ICER) of £5031 per QALY gained and an 85% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with the advice and exercise leaflet. US-guided injection was associated with an incremental cost of £15.89 (95% CI −59.36, 109.86) and 0.024 (95% CI −0.02, 0.07) additional QALYs, an ICER of £662 per QALY gained and a 83% chance of being cost-effective at a threshold of £20 000 per QALY gained compared with unguided injection. Conclusion Physiotherapist-led exercise was cost-effective compared with the advice and exercise leaflet, and US-guided injection was cost-effective when compared with unguided injection. Clinical trial registration ISRCTN, http://www.isrctn.com, ISRCTN42399123

BackgroundPolymyalgia rheumatica (PMR) is one of the most common inflammatory arthritic disorders seen in older individuals. Most patients with PMR are diagnosed and managed exclusively in general practice, yet primary care-focused research is lacking.AimTo identify and explore the challenges of diagnosis and management of PMR in general practice.Design and settingA multi-methods study in UK primary care.MethodThe multi-methods study comprised two complementary studies: a national questionnaire survey of 5000 randomly selected GPs from across the UK; and a qualitative semi-structured telephone interview study of UK GPs. Simple descriptive statistics were used to analyse questionnaire data. A thematic approach was used to analyse verbatim transcripts of the GP interviews.ResultsIn total, 1249 (25%) GPs responded to the questionnaire survey. From this total, 24 GPs were interviewed for the qualitative study. Features used by GPs to identify PMR were largely in line with current guidance. Diagnosis was found to be challenging, with GPs relying heavily on response to treatment with glucocorticoids. Investigations advised by current British PMR guidance to attempt to rule out other causes for symptoms were not routinely requested. Concerns surrounding ongoing treatment with glucocorticoids were widespread in relation to both potential adverse effects and ongoing monitoring.ConclusionFocused strategies to investigate and therefore exclude non-PMR differential diagnoses are required for patients with new-onset suspected PMR symptoms. Additionally, ongoing active review for alternative causes for symptoms as well as vigilance for treatment complications needs to be implemented.

Background Management of musculoskeletal conditions in the UK is increasingly delivered in multidisciplinary clinical assessment and treatment services (CATS) at the primary–secondary care interface. However, there is little evidence concerning the characteristics and management of patients attending CATS. Aim To describe the characteristics, investigation, and treatment of adults attending a musculoskeletal CATS. Design and setting Cross-sectional analysis of cohort study baseline data from a musculoskeletal CATS in Stoke-on-Trent Primary Care Trust, UK. Method All patients referred from primary care between February 2008 and June 2009 were mailed a pre-consultation questionnaire concerning pain duration, general health status, anxiety, depression, employment status, and work absence due to musculoskeletal problems. At the consultation, clinical diagnoses, body region(s) affected, investigations, and treatment were recorded. Result A total of 2166 (73%) completed questionnaires were received. Chronic pain duration >1 year (55%), major physical limitation (76%), anxiety (49%), and depression (37%) were common. Of those currently employed, 516 (45%) had taken time off work in the last 6 months because of their musculoskeletal problem; 325 (29%) were unable to do their usual job. The most frequent investigations were X-rays (23%), magnetic resonance imaging (18%), and blood tests (14%): 1012 (48%) received no investigations. Injections were performed in 282 (13%) and 492 (23%) were referred to physiotherapy. Conclusion Although most patients presented with musculoskeletal problems suitable for CATS, chronic pain, physical limitation, anxiety, depression, and work disability were commonplace, highlighting the need for a biopsychosocial model of care that addresses psychological, social, and work-related needs, as well as pain and physical disability.

BACKGROUND: The aim was to characterise the sociodemographic, general health and polymyalgia rheumatica (PMR)-specific features of participants in a large inception cohort of patients with PMR diagnosed in UK primary care. METHODS: Patients (n = 739) with a new diagnosis of PMR were referred into the study and mailed a questionnaire detailing their general health and sociodemographic characteristics in addition to the symptoms of and treatment for PMR. Characteristics of responders and non-responders were compared and descriptive statistics were used to characterise the health of the cohort. RESULTS: A total of 654 individuals responded to the questionnaire (adjusted response 90.1 %). Responders and non-responders were similar in age, gender and deprivation (based on postcode). The mean (standard deviation) age of the recruited cohort was 72.4 (9.3) years; 62.2 % were female. The sample reported high levels of pain and stiffness (8 out of 10 on numerical rating scales) and reported stiffness that lasted throughout the day. High levels of functional impairment, fatigue, insomnia and polypharmacy were also reported. Overall, women reported worse general and PMR-specific health than did men. CONCLUSIONS: This first primary care cohort of patients with incident PMR is similar in demographic terms to cohorts recruited in secondary care. However, the extent of symptoms, particularly reported stiffness, is higher than has been described previously. Given the majority of patients with PMR are exclusively managed in primary care, this cohort provides important information on the course of PMR in the community that will help clinicians managing this painful and disabling condition.

ObjectiveThis randomized controlled trial investigated the effects of upper- and lower-limb aerobic exercise training on disease-specific functional status and generic health-related quality of life (QOL) in patients with intermittent claudication.MethodsThe study recruited 104 patients (mean age, 68 years; range, 50-85) from the Sheffield Vascular Institute. Patients were randomly allocated to groups that received upper-limb (ULG) or lower-limb (LLG) aerobic exercise training, or to a nonexercise control group. Exercise was performed twice weekly for 24 weeks at equivalent limb-specific relative exercise intensities. Main outcome measures were scores on the Walking Impairment Questionnaire (WIQ) for disease-specific functional status, the Medical Outcomes Study Short Form version 2 (SF-36v2), and European Quality of Life Visual Analog Scale (EQ-VAS) for health-related QOL. Outcomes were assessed at baseline, and at 6, 24, 48, and 72 weeks.ResultsAfter 6 weeks, improvements in the perceived severity of claudication (P = .023) and stair climbing ability (P = .011) vs controls were observed in the ULG, and an improvement in the general health domain of the SF-36v2 vs controls was observed in the LLG (P = .010). After 24 weeks, all four WIQ domains were improved in the ULG vs controls (P ≤ .05), and three of the four WIQ domains were improved in the LLG (P < .05). After 24 to 72 weeks of follow-up, more consistent changes in generic health-related QOL domains were apparent in the ULG.ConclusionsThese findings support the use of alternative, relatively pain-free forms of exercise in the clinical management of patients with intermittent claudication.

Objectives To determine (1) reconsultation frequency, (2) change in self-reported health status, (3) baseline factors associated with reconsultation and change in health status and (4) associated healthcare costs and quality-adjusted life-years (QALYs), following assessment at a musculoskeletal Clinical and Assessment Treatment Service (CATS). Design Prospective cohort study. Setting Single musculoskeletal CATS at the primary–secondary care interface. Participants 2166 CATS attenders followed-up by postal questionnaires at 6 and 12 months and review of medical records. Outcome measures Primary outcome was consultation in primary care with the same musculoskeletal problem within 12 months. Secondary outcome measures were consultation at the CATS with the same musculoskeletal problem within 12 months, physical function and pain (Short Form-36), anxiety and depression (Hospital Anxiety and Depression Scale), time off work, healthcare costs and QALYs. Results Over 12 months, 507 (38%) reconsulted for the same problem in primary care and 345 (26%) at the CATS. Primary care reconsultation in the first 3 months was associated with baseline pain interference (relative risk ratio 5.33; 95% CI 3.23 to 8.80) and spinal pain (1.75; 1.09 to 2.82), and after 3–6 months with baseline assessment by a hospital specialist (2.06; 1.13 to 3.75). Small mean improvements were seen in physical function (1.88; 95% CI 1.44 to 2.32) and body pain (3.86; 3.38 to 4.34) at 6 months. Poor physical function at 6 months was associated with obesity, chronic pain and poor baseline physical function. Mean (SD) 6-month cost and QALYs per patient were £422.40 (660.11) and 0.257 (0.144), respectively. Conclusions While most patients are appropriate for a ‘one-stop shop’ model, those with troublesome, disabling pain and spinal pain commonly reconsult and have ongoing problems. Services should be configured to identify and address such clinical complexity.

Background Polymyalgia Rheumatica (PMR) is the commonest inflammatory condition seen in older patients in primary care. To date, however, research has been focused on secondary care cohorts rather than primary care where many patients are exclusively managed. This two year prospective inception cohort study of PMR patients will enable us to understand the full spectrum of this condition. Methods Patients diagnosed with PMR in primary care will be identified via Read codes and mailed a series of postal questionnaires over a two-year period to assess their levels of pain, stiffness and functioning, as well as medication usage and other health-related and socio-demographic characteristics. In addition, participants will be asked for permission to link their survey data to their general practice electronic medical record and to national mortality and cancer registers. Discussion This will be the first large-scale, prospective, observational cohort of PMR patients in primary care. The combination of survey data with medical records and national registers will allow for a full investigation of the natural history and prognosis of this condition in the primary care setting, in which the majority of patients are treated, but where little research on the treatment and outcome of consultation has been undertaken. This will provide information that may lead to improved primary care management of PMR.

This study assessed the feasibility of a 12-week program of exercise, with and without intramuscular testosterone supplementation, in male patients with chronic heart failure (CHF) and low testosterone status and collected preliminary data for key health outcomes.Male patients with CHF (n = 41, age 67.2 years, range 51-84 years) with mean ± SD testosterone levels of 10.7 ± 2.6 nmol/L (309 ± 76 ng/dL) were randomly allocated to exercise with testosterone or placebo groups. Feasibility was assessed in terms of recruitment, intervention compliance, and attrition. Outcomes included an incremental shuttle walk test, peak oxygen uptake, muscular strength, echocardiographic measures, N-terminal pro-brain natriuretic peptide, inflammatory markers, depression (Beck Depression Inventory), and health-related quality of life (Minnesota Living with Heart Failure Questionnaire and Medical Outcomes Study Short-Form).Attrition was 30% but with 100% compliance to exercise and injections in patients who completed the study. Similar improvements in shuttle walk test (18% vs 19%), body mass (-1.3 kg vs -1.0 kg), and hand grip strength (2.1 kg vs 2.5 kg) from baseline were observed in both groups. The exercise with testosterone group showed improvements from baseline in peak oxygen uptake (P.01), Beck Depression Inventory (P.05), leg strength (P.05), and several Medical Outcomes Study Short-Form quality of life domains (P.05), which were generally not apparent in the exercise with placebo group. Echocardiographic measures, N-terminal pro-brain natriuretic peptide, and inflammatory markers were mostly unchanged.This study shows for the first time that testosterone supplementation during a program of exercise rehabilitation is feasible and can positively impact on a range of key health outcomes in elderly male patients with CHF who have a low testosterone status.

Arm cranking is a useful alternative exercise modality for improving walking performance in patients with intermittent claudication; however, the mechanisms of such an improvement are poorly understood. The main aim of the present study was to investigate the effects of arm-crank exercise training on lower-limb O2 delivery in patients with intermittent claudication. A total of 57 patients with intermittent claudication (age, 70±8 years; mean±S.D.) were randomized to an arm-crank exercise group or a non-exercise control group. The exercise group trained twice weekly for 12 weeks. At baseline and 12 weeks, patients completed incremental tests to maximum exercise tolerance on both an arm-crank ergometer and a treadmill. Respiratory variables were measured breath-by-breath to determine peak V̇O2 (O2 uptake) and ventilatory threshold. Near-IR spectroscopy was used in the treadmill test to determine changes in calf muscle StO2 (tissue O2 saturation). Patients also completed a square-wave treadmill-walking protocol to determine V̇O2 kinetics. A total of 51 patients completed the study. In the exercise group, higher maximum walking distances (from 496±250 to 661±324 m) and peak V̇O2 values (from 17.2±2.7 to 18.2±3.4 ml·kg−1 of body mass·min−1) were recorded in the incremental treadmill test (P

Objectives To investigate the immediate effects of Nordic pole walking (NPW) on walking distance and cardiopulmonary workload in patients with intermittent claudication. Methods Using a standardised treadmill test (3.2 km h−1 at 4% gradient), walking distance, cardiopulmonary responses, leg pain and perceived exertion during NPW were compared to responses evoked by normal walking in 20 patients with intermittent claudication. The distance to onset of claudication pain (claudication distance: CD) and to maximum walking distance (MWD), heart rate (HR), expired gas parameters, leg pain (Borg's CR-10 Scale) and perceived exertion (Borg's Rating of Perceived Exertion: RPE Scale) were compared. Results CD increased significantly from a median (range) distance of 77 m (28–503) to 130 m (41–1080) and MWD increased significantly from 206 m (81–1078) to 285 m (107–1080) when patients used the Nordic poles (P = 0.000). The level of leg pain at MWD was also significantly reduced during NPW (P = 0.002). Perceived exertion at MWD did not increase despite an increase in cardiopulmonary work, as indicated by an increase in oxygen consumption (16.5%; P = 0.000). Conclusion These results show that NPW immediately enables patients with intermittent claudication to walk further with less pain, despite a higher workload. NPW might also be a useful exercise strategy for improving the cardiovascular fitness of patients with intermittent claudication.

Conclusions Detailed Gantt charts and visual, simplified, yet immensely beneficial flowcharts, can be easily embedded during grant application writing to illustrate the feasibility of studies within funding duration. The time investment in designing such tools at this stage allow studies to be visualised from an operational perspective early on, which help to ensure that studies can be delivered to time and target, once funded. Such tools should be implemented more widely to facilitate the smooth running of primary care research.

Background Testosterone deficiency is a common occurrence in men with chronic heart failure (CHF) and may underpin features of advanced disease, including reduced skeletal muscle mass and fatigue. It is positively correlated with cardiac output and exercise capacity in patients with CHF, whereas a significant improvement in both these parameters has been observed following testosterone replacement therapy. Testosterone therapy has also been shown to reduce circulating levels of inflammatory markers, (TNF-α, sICAM-1 and sVCAM-1) in patients with established coronary artery disease and testosterone deficiency. This pilot study will assess the feasibility of a combined exercise rehabilitation and adjunctive testosterone therapy intervention for evoking improvements in exercise capacity, circulating inflammatory markers, cardiac and skeletal muscle function, indices of psychological health status and quality of life in hypogonadal males with chronic heart failure. Methods/design Following ethical approval, 36 patients will be randomly allocated to one of two groups: testosterone or placebo therapy during exercise rehabilitation. A combined programme of moderate intensity aerobic exercise and resistance (strength) training will be used. The primary outcome measure is exercise capacity, assessed using an incremental shuttle walk test. Secondary outcome measures include measures of peak oxygen uptake, cardiac function, lower-limb skeletal muscle contractile function and oxygenation during exercise, circulating inflammatory markers, psychological health status and quality of life. Discussion Exercise rehabilitation can safely increase exercise capacity in stable CHF patients but there is a need for studies which are aimed at evaluating the long-term effects of physical training on functional status, morbidity and mortality. This pilot study will provide valuable preliminary data on the efficacy of testosterone therapy as an adjunct to exercise rehabilitation on a range of functional, physiological and health-related outcomes in this patient population. Preliminary data will be used in the design of a large-scale randomised controlled trial, aimed at informing clinical practice with respect to optimisation of exercise rehabilitation in this patient group.

ObjectivesTo investigate the effects of a 24-week program of upper- and lower-limb aerobic exercise training on walking performance in patients with symptomatic peripheral arterial disease (PAD) and to study the mechanisms that could influence symptomatic improvement.MethodsAfter approval from the North Sheffield Local Research Ethics Committee, 104 patients (median age, 69 years; range, 50 to 85 years) with stable PAD were randomized into an upper- or lower-limb aerobic exercise training group (UL-Ex or LL-Ex), or to a nonexercise training control group. Training was performed twice weekly for 24 weeks at equivalent relative exercise intensities. An incremental arm- and leg-crank test (ACT and LCT) to maximum exercise tolerance was performed before and at 6, 12, 18, and 24 weeks of the intervention to determine peak oxygen consumption (V̇O2). Walking performance, defined as the claudicating distance (CD) and maximum walking distance (MWD) achieved before intolerable claudication pain, was assessed at the same time points by using a shuttle-walk protocol. Peak blood lactate concentration, Borg ratings of perceived exertion (RPE) and pain category ratio (CR-10) were recorded during all assessments.ResultsCD and MWD increased over time (P < .001) in both training groups. At 24 weeks, CD had improved by 51% and 57%, and MWD had improved by 29% and 31% (all P < .001) in the UL-Ex and LL-Ex groups, respectively. An increase in peak heart rate at MWD in the UL-Ex group (109 ± 4 vs 115 ± 4 beats/min; P < .01) and LL-Ex group (107 ± 3 vs 118 ± 3 beats/min; P = .01) was accompanied by an increase in the amount of pain experienced in both groups (P < .05), suggesting that exercising patients could tolerate a higher level of cardiovascular stress and an increased intensity of claudication pain before test termination after training. Patients assigned to exercise training also showed an increase in LCT peak V̇O2 at the 24-week time point in relation to baseline (P < .01) and control patients (P < .01), whereas ACT peak V̇O2 was only improved in the UL-Ex group (P < .05).ConclusionsOur results suggest that a combination of physiologic adaptations and improved exercise pain tolerance account for the improvement in walking performance achieved through upper-limb aerobic exercise training in patients with PAD. Furthermore, that both arm- and leg-crank training could be useful exercise training modalities for improving cardiovascular function, walking performance, and exercise pain tolerance in patients with symptomatic PAD.

Objectives - To investigate the effects of peripheral arterial disease (PAD) on relative tolerance to upper- and lower-limb aerobic exercise. Methods - Peak cardiorespiratory responses evoked by an incremental arm-cranking test (ACT) and an incremental leg-cranking test (LCT) were compared in patients with PAD (N=101; median age 69 year, range 50-85 years). Claudication distance (CD) and total distance before intolerable claudication pain (maximum walking distance: MWD) were also assessed during walking. Results - Peak oxygen consumption (V O(2)) for the ACT was 94% of that measured for the LCT (1.01+/-0.03 versus 1.10+/-0.03lmin(-1), respectively; P

To compare treadmill and shuttle walk tests for assessing functional capacity in patients with intermittent claudication, with respect to test-retest reliability, cardiovascular responses, and patient preferences.Patients with stable intermittent claudication (N = 55, ages 52-85 yr, median age 68 yr) were recruited from the Sheffield Vascular Institute at the Northern General Hospital, Sheffield, UK. Each patient performed an incremental shuttle walk test, a constant-pace shuttle walk test, and a standardized treadmill test (3.2 km x h(-1), 12% gradient), each on three occasions. The incremental shuttle walk began at 3 km x h(-1) and increased by 0.5 km x h(-1) every minute, whereas the constant-pace shuttle walk was performed at the fixed pace of 4 km x h(-1). Claudication distance (CD), maximum walking distance (MWD), heart rate (HR), and blood pressure were assessed in each testing session. The patients also completed a test preference questionnaire.CD and MWD for both shuttle walks were greater than the corresponding walking distances achieved in the treadmill test (P0.001). Average coefficients of variation for repeated incremental shuttle walk, constant-pace shuttle walk, and treadmill tests were 15.9%, 21.1%, and 18.7%, respectively, for MWD, corresponding to average intraclass correlation coefficients of 0.87, 0.82, and 0.87. Treadmill walking evoked greater increases in HR and blood pressure (P0.001), and fewer patients expressed a preference for it (24 vs 43% for shuttle walking).These findings indicated that shuttle walk testing exhibits similar test-retest reliability as treadmill testing, but that it evoked a lower level of cardiovascular stress and is preferred to treadmill testing by a large proportion of patients.

Background Gout is the commonest inflammatory arthritis affecting around 1.4% of adults in Europe. It is predominantly managed in primary care and classically affects the joints of the foot, particularly the first metatarsophalangeal joint. Gout related factors (including disease characteristics and treatment) as well as comorbid chronic disease are associated with poor Health Related Quality of Life (HRQOL) yet to date there is limited evidence concerning gout in a community setting. Existing epidemiological studies are limited by their cross-sectional design, selection of secondary care patients with atypical disease and the use of generic tools to measure HRQOL. This 3 year primary care-based prospective observational cohort study will describe the spectrum of HRQOL in community dwelling patients with gout, associated factors, predictors of poor outcome, and prevalence and incidence of foot problems in gout patients. Methods Adults aged ≥ 18 years diagnosed with gout or prescribed colchicine or allopurinol in the preceding 2 years will be identified through Read codes and mailed a series of self-completion postal questionnaires over a 3-year period. Consenting participants will have their general practice medical records reviewed. Discussion This is the first prospective cohort study of HRQOL in patients with gout in primary care in the UK. The combination of survey data and medical record review will allow an in-depth understanding of factors that are associated with and lead to poor HRQOL and foot problems in gout. Identification of these factors will improve the management of this prevalent, yet under-treated, condition in primary care.

The purpose of this investigation was to identify physiological predictors of maximum treadmill walking performance (MWD) in patients with intermittent claudication. Forty-five claudicants performed a graded treadmill test to determine MWD, peak oxygen uptake, and gas exchange threshold. Calf muscle oxygenation (StO (2)) at 1 min and time to minimum StO (2) were also measured using near-infrared spectroscopy. On other occasions, peak calf blood flow, resting ankle-brachial index, and pulmonary oxygen uptake kinetics during steady-state walking were assessed. A forward stepwise multiple regression analysis was performed to determine predictors of MWD. A regression model comprising time to minimum StO (2), peak oxygen uptake, and StO (2) at 1 min explained 64% of the variation in MWD. The results suggest that cardiopulmonary fitness and the ability to match oxygen delivery to metabolic demand are important determinants of walking performance in claudicants, and that certain near-infrared spectroscopy variables might be useful in studies that evaluate the mechanisms of clinical improvement with different treatment interventions.

Background Recent healthcare policy has shifted the management of musculoskeletal conditions in the UK away from secondary care towards Clinical Assessment and Treatment Services at the primary-secondary care interface. However, little is known about the outcome of patients with musculoskeletal conditions referred from primary care to Clinical Assessment and Treatment Services or how best to identify those patients at high risk of poor outcome in this setting. We describe the protocol for a twelve-month prospective observational study which aims to describe the outcome of patients referred to musculoskeletal and back pain services at the primary-secondary care interface and to develop simple prognostic measures to guide clinical prioritisation and triage. Methods/Design All patients referred over a twelve-month period from primary care to musculoskeletal and back pain clinics in the primary-secondary care interface Clinical Assessment and Treatment Service in North Staffordshire will be mailed a postal questionnaire prior to their consultation. This will collect information on quality of life, general health, anxiety and depression, pain, healthcare utilisation including medication use, occupational characteristics, and socio-demographics. At the consultation in the interface clinic, the clinical diagnosis, investigations requested, and clinical interventions will be recorded. Follow-up data for the twelve-month period subsequent to recruitment will be collected via mailed follow-up questionnaires at 6 and 12 months, and review of medical records. Discussion This twelve-month prospective observational study of patients referred to a musculoskeletal Clinical Assessment and Treatment Service will assess the management and outcome of musculoskeletal care at the primary-secondary care interface as proposed in the Musculoskeletal Services Framework.

Background Subacromial impingement syndrome is the most frequent cause of shoulder problems which themselves affect 1 in 3 adults. Management commonly includes exercise and corticosteroid injection. However, the few existing trials of exercise or corticosteroid injection for subacromial impingement syndrome are mostly small, of poor quality, and focus only on short-term results. Exercise packages tend to be standardised rather than individualised and progressed. There has been much recent interest in improving outcome from corticosteroid injections by using musculoskeletal ultrasound to guide injections. However, there are no high-quality trials comparing ultrasound-guided and blind corticosteroid injection in subacromial impingement syndrome. This trial will investigate how to optimise the outcome of subacromial impingement syndrome from exercise (standardised advice and information leaflet versus physiotherapist-led exercise) and from subacromial corticosteroid injection (blind versus ultrasound-guided), and provide long-term follow-up data on clinical and cost-effectiveness. Methods/Design The study design is a 2x2 factorial randomised controlled trial. 252 adults with subacromial impingement syndrome will be recruited from two musculoskeletal Clinical Assessment and Treatment Services at the primary-secondary care interface in Staffordshire, UK. Participants will be randomised on a 1:1:1:1 basis to one of four treatment groups: (1) ultrasound-guided subacromial corticosteroid injection and a physiotherapist-led exercise programme, (2) ultrasound-guided subacromial corticosteroid injection and an advice and exercise leaflet, (3) blind subacromial corticosteroid injection and a physiotherapist-led exercise programme, or (4) blind subacromial corticosteroid injection and an advice and exercise leaflet. The primary intention-to-treat analysis will be the mean differences in Shoulder Pain and Disability Index (SPADI) scores at 6 weeks for the comparison between injection interventions and at 6 months for the comparison between exercise interventions. Although independence of treatment effects is assumed, the magnitude of any interaction effect will be examined (but is not intended for the main analyses). Secondary outcomes will include comparison of long-term outcomes (12 months) and cost-effectiveness. A secondary per protocol analysis will also be performed. Discussion This protocol paper presents detail of the rationale, design, methods and operational aspects of the SUPPORT trial. Trial registration Current controlled trials ISRCTN42399123.