PHYSICAL THERAPY & REHAB
A Randomized, Single-Blind, Placebo- Controlled Study on the Efficacy of the Arthrokinematic Approach-Hakata Method in Patients with Chronic Nonspecific Low Back Pain
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(9):27 PLoS One. 2015 Dec 8;10(12):e0144325186 patients diagnosed with chronic nonspecific low back pain were randomized to receive either the Arthrokinematic approach-Hakata (AKA-H) method (manual therapy) or a sham treatment, once a month for 6 months. The purpose of the study was to determine if the AKA-H method positively affected pain, disability and quality of life after 6 months of treatment. The results suggested that patients in the AKA-H group displayed significant improvements compared to the sham group in pain scores, disability, and quality of life that generally began after 3 months and lasted for the remainder of the 6 month study period.
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？
Chronic nonspecific low back pain is very common in the general population and is associated with a reduced quality of life. While this condition is prevalent in the general population a gold standard for effective management has yet to be defined. Various conservative therapies exist; however, these treatments vary in effectiveness from patient to patient. The Arthrokinematic Approach-Hakata (AKA-H) method is a manual procedure for treating abnormalities of intraarticular movement of the synovial joint and guides movement on the joint surface. Although not indicated for a specific pathology, the efficacy of the AKA-H method in the treatment of low back pain warranted examination.
主な研究課題は何ですか？
In adults with chronic low back pain, how did the Arthrokinematic approach-Hakata method affect pain and quality of life in comparison to sham treatment when assessed over 6 months?
重要な知見は？
- The mean VAS pain score at 6 months was significantly lower in the AFA-H group when compared to the sham group (31.2 +/- 18.8 vs. 45.5 +/- 22.0; p<0.0016). This difference was also observed at months 3-5 (all p<0.0016), however, no significant differences between groups were noted at months 1 and 2 (both p>0.05)
- RDQ scores were similar between groups from months 1-3 (p>0.05), however, the AFA-H group displayed significantly greater improvements at months 4 (p<0.008), 5 (p<0.0016) and 6 (AFA-H: 49.3 +/- 9.3 vs. Sham: 42.6 +/- 9.9; p<0.0016)
- SF-36 subscores were significantly better in the AFA-H group in terms of bodily pain and mental health from months 2-6, in physical functioning, social functioning, general health perception, vitality, and emotional role functioning from months 3-6, and in physical role functioning from months 4-6 (p<0.008)
- Mild side effects, including muscle weakness and lower leg numbness, were comparable between groups
最も覚えておくべきことは？
For patients with nonspecific low back pain, management using the Arthrokinematic approach-Hakata method displayed significant improvements in VAS pain scores after 3 months which were sustained until final follow-up at 6 months when compared to sham treatment. Additionally, the AKA-H patients displayed significantly greater improvements in disability and quality of life, generally beginning after the third month of treatment, and lasting for the remainder of the study period.
それが私の患者ケアにどのように影響するか？
The results of this randomized controlled trial suggest that the Arthrokinematic approach-Hakata method, for the treatment of patients with chronic low back pain, may improve pain, disability, and quality of life after 6 months of monthly treatment when compared to a sham treatment. However, further trials using a double-blind methodology that include a more gender-balanced population are required to further elucidate the efficacy of this treatment.
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