SPINE
A randomised controlled trial of post-operative rehabilitation after surgical decompression of the lumbar spine
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(11):268 Eur Spine J. 2007 Aug;16(8):1101-17. Epub 2007 Jun 26167 patients with degenerative spinal disease (spinal stenosis/herniated disc) undergoing decompression surgery were randomized to either receive physiotherapy with stabilization exercises, physiotherapy with mixed techniques or no therapy/self management. The results indicated that both physiotherapy with spine stabilization exercises and physiotherapy with mixed techniques were not superior to advice to remain active with enjoyable activities (control).
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
2/4
Randomização
2/4
Medidas de resultado
4/4
Inclusão/Exclusão
4/4
Descrição do tratamento
4/4
Estatística
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Degenerative lumbar spine diseases that cause compression of the neural elements occur frequently in the ageing population. The symptoms and consequences that result from such diseases negatively impact the affected individual's ability to perform activities of daily living, and compromise their independence. Surgery is often required for these cases, and the success rates of surgery are reportedly low. The use of active rehabilitation programs following spinal surgery has proven to have benefits in younger patient populations, however it's use in elderly patients remains uncertain.
主な研究課題は何ですか？
How do the outcomes compare between no supervised therapy, physiotherapy with spine stabilization exercises, or physiotherapy with mixed techniques are performed following decompression surgery, in patients with degenerative spinal disease, measured over 2 years?
重要な知見は？
- Following surgery, a significant reduction (p<0.05) in the Roland Morris Disability Scores was observed, however there were no significant differences between the two groups (p>0.05). Between first (pre-rehab) and second (post-rehab) follow up periods, a further reduction in disability was observed with no significant differences between groups (p>0.05).No significant changes were observed up until the 24 month follow up period. (p>0.05)
- After surgery, both groups showed a significant reduction (p<0.05) in leg pain, back pain, and all average pain scores. Leg pain remained constant over the rehabilitation phase, but a significant increase (in all groups; each p<0.05) was observed from end of rehab to 12 month follow up. Until the 24 month period, leg pain was stable.
- At 2, 12 and 24 months after surgery, there were no significant differences between groups in terms of global outcome assessments (p>0.05).
最も覚えておくべきことは？
In comparison to no therapy/self-management, supervised physiotherapy demonstrated no significant influence on the change in pain and disability scores, up to 24 months following surgery.
それが私の患者ケアにどのように影響するか？
Regardless of the therapy given, this study shows that patients still experience moderate disability in their every day life, resulting from back issues. Encouraging patients to continue with activities they enjoy doing, may be as effective as a supervised physiotherapy program- with low-cost to the health-care provider. Further large-scale, high-quality evidence is needed to validate these findings.
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