SPINE
A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(14):10 Pain Med. 2012 Mar;13(3):383-98. doi: 10.1111/j.1526-4637.2012.01328.x. Epub 2012 Feb 2Exclusive Author Interview
Dr. Patel discusses the use of lateral branch neurotomy for sacroiliac joint pain improves pain and physical function
51 patients experiencing sacroiliac joint (SIJ) pain were randomized on a 2:1 basis into two groups to either receive lateral branch radiofrequency (RF) neurotomy or a sham treatment. Following assessments over a 9 month period, results indicated that patients who underwent lateral branch RF neurotomy treatment noticed a significant decrease in pain, disability, and an increase in physical function.
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
Randomização
4/4
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？
Sacroiliac joint (SIJ) pain is a common form of lower back pain. Intra-articular SIJ injections are normally used to treat the condition, but sometimes this method is ineffective or only provides short-term pain relief. Lateral branch RF neurotomy has been suggested as an alternative treatment for SIJ pain, but few studies have assessed the efficacy of this method. This study aimed to determine the effectiveness of lateral branch RF neurotomy in pain management of SIJ pain.
主な研究課題は何ですか？
Did lateral branch radiofrequency neurotomy significantly decrease sacroiliac joint pain and increase physical function, when measured over a 9 month period?
重要な知見は？
- The mean improvement in NRS pain score at the 3 month assessment was significantly higher in the Lateral Branch Neurotomy group (-2.4 +/- 2.7) than in the Sham group (-0.8 +/- 2.4) (p=0.035)
- The mean improvements in SF-36 for bodily pain at the 1 and 3 month assessments were significantly higher in the Lateral Branch Neurotomy group (Month 1: 15 +/- 17, Month 3: 16 +/- 26) than in the Sham group (Month 1: 2 +/- 11, Month 3: -1 +/- 13) (Month 1: p=0.006, Month 3: p=0.019)
- The mean improvements in SF-36 for physical function at the 1 and 3 month assessments were significantly higher in the Lateral Branch Neurotomy group (Month 1: 10 +/- 17, Month 3: 14 +/- 19) than in the Sham group (Month 1: 5 +/- 12, Month 3: 3 +/- 12) (Month 1: p=0.238, Month 3: p=0.040)
- The mean improvements in ODI at the 1 and 3 month assessments were significantly higher in the Lateral Branch Neurotomy group (Month 1: -12 +/- 14, Month 3: -11 +/- 17) than in the Sham group (Month 1: -4 +/- 11, Month 3: 2 +/- 6) (Month 1: p=0.046, Month 3: p=0.011)
- The percentage of patients who had a positive GPE score (positive defined as “pain has decreased a lot”) at the 3 month assessment was significantly higher in the Lateral Branch Neurotomy group (47%) than in the Sham group (8%) (p<0.05)
- The mean AQoL score at the 3 month assessment was significantly higher in the Lateral Branch Neurotomy group (0.69 +/- 0.21) than in the Sham group (0.56 +/- 0.21) (p=0.048)
最も覚えておくべきことは？
Patients who underwent lateral branch RF neurotomy experienced significant improvements in SIJ pain, disability, physical function, and quality of living compared to those who underwent the sham treatment.
それが私の患者ケアにどのように影響するか？
Patients who have failed to get pain alleviation after taking intra-articular SIJ injections are may benefit from lateral branch RF neurotomy. Further research with larger sample sizes and longer follow-up are required to confirm the benefits.
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