Clinical and radiological outcome of conservative vs. surgical treatment of atraumatic degenerative rotator cuff rupture: design of a randomized controlled trial

Background: Subacromial impingement syndrome is a frequently observed disorder in orthopedic practice. Lasting symptoms and impairment may occur when a subsequent atraumatic rotator cuff rupture is also present. However, degenerative ruptures of the rotator cuff can also be observed in asymptomatic elderly individuals. Treatment of these symptomatic degenerative ruptures may be conservative or surgical. Acceptable results are reported for both treatment modalities. No evidence-based level-1 studies have been conducted so far to compare these treatment modalities. The objective of this study is to determine whether there is a difference in outcome between surgical reconstruction and conservative treatment of a degenerative atraumatic rotator cuff tendon rupture. Methods/Design: A randomized controlled trial will be conducted. Patients aged between 45 and 75 with a symptomatic atraumatic rotator cuff rupture as diagnosed by MRI will be included. Exclusion criteria are traumatic rotator cuff rupture, frozen shoulder and diabetes mellitus. Patients will be randomized into two groups. Conservative treatment includes physical therapy according to a standardized protocol, NSAIDs and, if indicated, subacromial infiltration with a local anesthetic and corticosteroids. Surgical reconstruction is performed under general anesthesia in combination with an interscalenus plexus block. An acromioplasty with reconstruction of the rotator cuff tendon is performed, as described by Rockwood et al. Measurements take place preoperatively and 6 weeks, 3 months, 6 months and 1 year postoperatively. The primary outcome measure is the Constant score. Secondary measures include both disease-specific and generic outcome measures, and an economic evaluation. Additionally, one year after inclusion a second MRI will be taken of all patients in order to determine whether extent and localization of the rupture as well as the amount of fatty degeneration are prognostic factors. Discussion: Both surgical as conservative treatment of a symptomatic atraumatic rotator cuff tendon rupture is used in current practice. There is a lack of level-1 studies comparing surgical vs. conservative treatment. This randomized controlled trial has been designed to determine whether the surgical treatment of a degenerative atraumatic rotator cuff tendon rupture may lead to a better functional and radiological outcome than conservative treatment after one year of follow-up

Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol

Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory

Research priorities for non-pharmacological therapies for common musculoskeletal problems: nationally and internationally agreed recommendations

<p>Abstract</p> <p>Background</p> <p>Musculoskeletal problems such as low back pain, neck, knee and shoulder pain are leading causes of disability and activity limitation in adults and are most frequently managed within primary care. There is a clear trend towards large, high quality trials testing the effectiveness of common non-pharmacological interventions for these conditions showing, at best, small to moderate benefits. This paper summarises the main lessons learnt from recent trials of the effectiveness of non-pharmacological therapies for common musculoskeletal conditions in primary care and provides agreed research priorities for future clinical trials.</p> <p>Methods</p> <p>Consensus development using nominal group techniques through national (UK) and international workshops. During a national Clinical Trials Thinktank workshop in April 2007 in the UK, a group of 30 senior researchers experienced in clinical trials for musculoskeletal conditions and 2 patient representatives debated the possible explanations for the findings of recent high quality trials of non-pharmacological interventions. Using the qualitative method of nominal group technique, these experts developed and ranked a set of priorities for future research, guided by the evidence from recent trials of treatments for common musculoskeletal problems. The recommendations from the national workshop were presented and further ranked at an international symposium (hosted in Canada) in June 2007.</p> <p>Results</p> <p>22 recommended research priorities were developed, of which 12 reached consensus as priorities for future research from the UK workshop. The 12 recommendations were reduced to 7 agreed priorities at the international symposium. These were: to increase the focus on implementation (research into practice); to develop national musculoskeletal research networks in which large trials can be sited and smaller trials supported; to use more innovative trial designs such as those based on stepped care and subgrouping for targeted treatment models; to routinely incorporate health economic analysis into future trials; to include more patient-centred outcome measures; to develop a core set of outcomes for new trials of interventions for musculoskeletal problems; and to focus on studies that advance methodological approaches for clinical trials in this field.</p> <p>Conclusion</p> <p>A set of research priorities for future trials of non-pharmacological therapies for common musculoskeletal conditions has been developed and agreed through national (UK) and international consensus processes. These priorities provide useful direction for researchers and research funders alike and impetus for improvement in the quality and methodology of clinical trials in this field.</p

Shoulder pain - where are we now?

Purpose of review: shoulder pain is common and costly. For the past century, diagnosis and management has been based upon presumed patho-anatomical abnormalities. With the evolution of imaging techniques and new insight about the causes of musculoskeletal pain, this review evaluates the evidence that a patho-anatomical approach remains justified. Recent findings: imaging modalities have developed considerably but, so far, have only proven value in evaluating full thickness rotator cuff tears prior to surgery. Correlation between imaging findings and symptoms is otherwise poor, with limited evidence of the value and impact of imaging for decision-making. Much of shoulder pain is chronic and few people have single-site musculoskeletal pain. Pain studies suggest that chronic shoulder pain is associated with both central and peripheral pain sensitisation. Moreover, functional MRI points to an effect of cognitive affective pain processing rather than nociception. Few of the established therapies, medical or surgical, that treat the presumed patho-anatomical cause have been shown to have lasting benefit. Summary: much of the evidence suggests that shoulder pain is more similar than different from mechanical low back pain. For most people with shoulder pain, the best approach might well be de-medicalisation, support to (self)manage pain, emphasis on retaining movement and identifying adverse beliefs and risk factors for disability and chronicity. Approaches like this are currently being evaluated and more research is desperately required.Introduction<br/

Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol

BACKGROUND: Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory.\n\nMETHODS: Adults aged 18 years and over consulting their General Practitioner (GP) with LBP and radiating leg pain of any duration at (n = 500) GP practices in North Staffordshire and Stoke-on-Trent, UK will be invited to participate. All participants will receive a standardised assessment at the clinic by a study physiotherapist and will be classified according to the clinically determined presence or absence of nerve root pain/involvement. All will undergo a lumbar spine MRI scan. All participants will be managed according to their clinical need. The study outcomes will be measured at 4 and 12 months using postal self-complete questionnaires. Data will also be collected each month using brief postal questionnaires to enable detailed description of the course of low back and leg pain over time. Clinical observations and patient interviews will be used for the qualitative aspects of the study.\n\nDISCUSSION: This prospective clinical observational cohort will combine self-reported data, comprehensive clinical and MRI assessment, together with qualitative enquiries, to describe the course, health care usage, patients' experiences and prognostic indicators in an adult population presenting in primary care with LBP and leg pain with or without nerve root involvement

Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol

Abstract Background Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory. Methods Adults aged 18 years and over consulting their General Practitioner (GP) with LBP and radiating leg pain of any duration at (n = 500) GP practices in North Staffordshire and Stoke-on-Trent, UK will be invited to participate. All participants will receive a standardised assessment at the clinic by a study physiotherapist and will be classified according to the clinically determined presence or absence of nerve root pain/involvement. All will undergo a lumbar spine MRI scan. All participants will be managed according to their clinical need. The study outcomes will be measured at 4 and 12 months using postal self-complete questionnaires. Data will also be collected each month using brief postal questionnaires to enable detailed description of the course of low back and leg pain over time. Clinical observations and patient interviews will be used for the qualitative aspects of the study. Discussion This prospective clinical observational cohort will combine self-reported data, comprehensive clinical and MRI assessment, together with qualitative enquiries, to describe the course, health care usage, patients' experiences and prognostic indicators in an adult population presenting in primary care with LBP and leg pain with or without nerve root involvement.</p