Abstract:
OBJECTIVE:To assess the efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy, a placebo surgical intervention, and with a non-operative alternative, exercise therapy, in a more pragmatic setting. DESIGN:Multicentre, three group, randomised, double blind, sham controlled trial. SETTING:Orthopaedic departments at three public hospitals in Finland. PARTICIPANTS:210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015. INTERVENTIONS:ASD, diagnostic arthroscopy (placebo control), and exercise therapy. MAIN OUTCOME MEASURES:Shoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15. RESULTS:In the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were -4.6 (95% confidence interval -11.3 to 2.1) points (P=0.18) at rest and -9.0 (-18.1 to 0.2) points (P=0.054) on arm activity. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (-7.5, -14.0 to -1.0, points; P=0.023) and VAS on arm activity (-12.0, -20.9 to -3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group. CONCLUSIONS:In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months. TRIAL REGISTRATION:Clinicaltrials.gov NCT00428870.
journal_name
BMJjournal_title
BMJ (Clinical research ed.)authors
Paavola M,Malmivaara A,Taimela S,Kanto K,Inkinen J,Kalske J,Sinisaari I,Savolainen V,Ranstam J,Järvinen TLN,Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators.doi
10.1136/bmj.k2860subject
Has Abstractpub_date
2018-07-19 00:00:00pages
k2860eissn
0959-8138issn
1756-1833journal_volume
362pub_type
杂志文章,多中心研究,随机对照试验abstract:OBJECTIVES:To determine the impact on teenage pregnancy of interventions that address the social disadvantage associated with early parenthood and to assess the appropriateness of such interventions for young people in the United Kingdom. DESIGN:Systematic review, including a statistical meta-analysis of controlled tr...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,meta分析,评审
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abstract:OBJECTIVES:To provide insight into factors that contribute to the anxiety reported in a quantitative study of the psychological effect of screening for type 2 diabetes. To explore expectations of and reactions to the screening experience of patients with positive, negative, and intermediate results. DESIGN:Prospective...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2007-09-08 00:00:00
abstract:OBJECTIVE:To determine the incidence of cervical cancer after several negative cervical smear tests at different ages. DESIGN:Prospective observational study of incidence of cervical cancer after the third consecutive negative result based on individual level data in a national registry of histopathology and cytopatho...
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abstract:OBJECTIVES:To calculate socioeconomic and health status measures for the primary care groups in London and to examine the association between these measures and hospital admission rates. DESIGN:Cross sectional study. SETTING:66 primary care groups in London, total list size 8.0 million people. MAIN OUTCOME MEASURES:...
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abstract:OBJECTIVE:To determine the effects on independence in older people needing rehabilitation in a locality based community hospital compared with care on a ward for elderly people in a district general hospital. DESIGN:Randomised controlled trial. SETTING:Care in a community hospital and district general hospital in Bra...
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abstract:OBJECTIVE:To investigate the association between cerebral palsy and direct evidence for perinatal exposure to neurotropic viruses. DESIGN:Population based case-control study. SETTING:Adelaide Women's and Children's Hospital Research Laboratory. PARTICIPANTS AND MAIN OUTCOME MEASURES:Newborn screening cards of 443 wh...
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doi:10.1136/bmj.38668.616806.3A
更新日期:2006-01-14 00:00:00
abstract:OBJECTIVE:To confirm the findings of pilot studies that interferon alfa is an effective treatment of Europid men with chronic hepatitis B virus infection. DESIGN:Randomised controlled trial of three months treatment with interferon alfa followed by 12 months of observation. SETTING:Outpatient clinic of a tertiary ref...
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pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1989-09-09 00:00:00
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更新日期:2007-05-12 00:00:00
abstract:OBJECTIVE:To assess the risk of cerebral thromboembolism in women using low dose oral contraceptives. DESIGN:A retrospective case-control study. SETTING:All Danish medical, neurological, neurosurgical, and gynaecological departments. SUBJECTS:All 794 women in Denmark aged 15-44 who had suffered a cerebral thromboemb...
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abstract:OBJECTIVE:To assess the extent to which the prevailing model of smoking cessation (that smokers typically prepare their attempts to stop smoking in advance and that doing so increases their chances of success) is correct. DESIGN:Cross sectional household survey. SETTING:England. PARTICIPANTS:918 smokers who reported...
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更新日期:2006-02-25 00:00:00
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更新日期:1994-07-09 00:00:00
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更新日期:2005-01-29 00:00:00