SPINE
Effects of an exercise and manual therapy program on physical impairments, function, and quality-of-life in people with osteoporotic vertebral fracture: A randomised, single-blind controlled pilot trial
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):180 BMC Musculoskelet Disord. 2010 Feb 17;11:36.20 patients (>50 yr of age) with a history of painful osteoporotic vertebral fracture were randomized to a structured exercise program or no treatment for a period of 10 weeks. At 11 weeks, it was observed that combined manual therapy and exercise were effective in reducing pain and improving physical function for patients with osteoporotic vertebral fractures.
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。
3/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
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？
Pharmacological therapy is the primary treatment for patients with vertebral fractures. However, the majority of the drugs have no direct effect on pain and physical impairments that patients experience. There is a dearth of literature that investigates the role of physiotherapy in patients with vertebral fractures, which is alluded to in this study.
主な研究課題は何ですか？
In people with a history of painful osteoporotic vertebral fracture, what is the effectiveness of a physiotherapy program in reducing pain after 10 weeks?
重要な知見は？
- After the 10-week trial, the intervention group had a statistically significant reduction in pain during movement and at rest, compared to the control group.
- There was a statistically significant difference between the two groups in the time loaded standing test; the intervention group experienced an improvement in trunk and arm muscle endurance, while the control group experienced deterioration.
- A statistically significant difference in physical function was observed between the intervention group had an improvement in the Qualeffo physical function score compared with the control group.
- The two groups did not differ with respect to the AQoL scores and changes in thoracic kyphosis.
- 82% of patients with the physical therapy, compared to 11% of patients in control group, judged their pain to be much better than at the time of enrollment.
最も覚えておくべきことは？
Study findings showed that patients with osteoporotic vertebral fractures experienced reduction in pain and improvement in physical function after undergoing a 10-week physiotherapy program. As this was a pilot study with a small sample size, the results should be interpreted with caution and necessitate confirmation with a larger sample size RCT.
それが私の患者ケアにどのように影響するか？
In treating patients with a history of painful osteoporotic vertebral fracture, a structured monitored physiotherapy program with an expert clinician and regular home exercises may be effective in improving quality of life parameters of patients. However, due to the small sample size of participants featured in this trial, it is difficult to draw definitive conclusions on the efficacy of the physiotherapy regimen used in this trial. Additional research, including outcome at follow-up, is necessary to further examine the physiotherapy's effect on pain in osteoporotic individuals.
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