SPINE
Manual therapy followed by specific active exercises versus a placebo followed by specific active exercises on the improvement of functional disability in patients with chronic non specific low back pain: a randomized controlled 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(6):91 BMC Musculoskelet Disord. 2012 Aug 28;13:162. doi: 10.1186/1471-2474-13-162.42 chronic non-specific low back pain patients without co-morbidities were randomized to receive spinal manipulation plus active exercises or detuned ultrasound plus active exercises. The results of the study indicate that manual therapy alone produced a slightly greater immediate analgesic effect, but the combination of manual therapy and active exercises resulted in reduced disability and a trend towards lower back pain.
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。
4/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
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？
For approximately 10% of nonspecific low back pain sufferers, pain and disability may be experienced for a longer period of time. Unfortunately, treatment of chronic non-specific low back pain can be complicated, expensive, and inconsistently effective. This study aimed to determine whether manual therapy produces an analgesic effect and whether manual therapy followed by active exercises improves functional disability when compared to sham therapy followed by active exercises.
主な研究課題は何ですか？
Does manual therapy followed by active exercises improve the functional disability of patients with chronic non-specific low back pain when compared to sham therapy followed by active exercises, 6 months after treatment?
重要な知見は？
- Immediately after manual therapy or sham therapy, the patients who received manual therapy experienced a significant reduction in mean pain level when compared to the patients that received sham therapy (Mean difference: -0.76 VAS; 95% CI: -1.22 to -0.30).
- The patients that completed manual therapy followed by active exercises displayed a trend towards a significant reduction in pain when compared to the patients that completed sham therapy followed by active exercises (Mean difference: -1.24; 95% CI: -2.73 to -0.30; p=0.032).
- Disability was found to be significantly less among the patients that underwent manual therapy and active exercise when compared to the patients that underwent sham therapy and active exercise (Mean difference: -7.14; 95% CI:-12.8 to -1.52; p=0.013).
- At the immediate and 3 month follow-ups, there was no significant difference in mean Shirado score (erector spine and abdominal muscles endurance) between the two treatment groups (p=0.352 and p=0.246, respectively), but at the 6 month follow-up, the Shirado score was significantly lower among the patients that underwent manual therapy than the patients that underwent the sham therapy (p=0.031).
- There were no significant differences in Sorensen scores or Fear-Avoidance Beliefs Questionnaire scores between the treatment groups.
最も覚えておくべきことは？
The data suggests that manual therapy provides immediate analgesic effects. The combination of manual therapy and active exercises improved disability and displayed a trend towards significantly reducing pain. The combination of sham therapy and active exercises significantly improved mean Shirado scores.
それが私の患者ケアにどのように影響するか？
The study suggests that manual therapy may provide immediate analgesic effects and the combination of manual therapy and active exercises may significantly improve disability and display a trend towards significantly improving pain. Further research using larger sample sizes are required to detect significant differences in study outcomes.
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