SHOULDER & ELBOW
Treatment of myofascial pain syndrome with lidocaine injection and physical therapy, alone or in combination: a single blind, randomized, controlled clinical trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(8):24 BMC Musculoskelet Disord. 2016 Feb 24;17(1):101.135 patients with myofascial pain syndrome located in the muscles of the shoulder were randomized to either physical therapy, lidocaine injection, or a combination of physical therapy and lidocaine injection, for the purpose of determining whether combination therapy is more effective than monotherapies for improving pain, function, and quality of life outcomes after 3 months. Results demonstrated that all relevant clinical outcomes were comparable between all study groups at final follow-up, suggesting that the combination of the two monotherapies was equally as effective as its singular components.
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
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？
Myofascial pain syndrome (MPS) is often characterized by the presence of myofascial trigger points (MTrPs) and associated hypersensitive areas that induce pain, tenderness, and autonomic behaviour when manipulated. Current conservative treatments include ultrasound therapy, massage and stretching with aerosolized fluoromethane, and physiotherapy. However, whether or not a superior treatment (or combination of treatments) exists has yet to be determined, and thus, the current study was conducted.
主な研究課題は何ですか？
For patients with myofascial pain syndrome, did the combination of physical therapy and lidocaine injection (without epinephrine) demonstrate significantly improved pain ratings, function, quality of life, and depressive symptoms when compared to physical therapy or lidocaine injection alone, as assessed up to 3 months post-intervention?
重要な知見は？
- VAS pain scores measured 1-month post-intervention were similar when patients who received combination therapy (PT+LI) were compared to patients who received physical therapy alone (PT group, p=0.56) and those who received lidocaine injection therapy alone (LI group, p=0.545).
- PHQ-9 and SF-36 subscale (measuring depression symptoms and quality of life, respectively) differences between groups were not significant after one-month post-treatment. When SF-36 subscales were analyzed individually, patients in the PT+LI group recorded significant improvements in health when compared to patients in the PT group (p=0.03). No statistical difference was observed between the LI group and the PT+LI group.
- VAS pain scores, PHQ-9 scores, and SF-36 scores were comparable between all study groups when measured at 3 months post-intervention (p>0.05).
- Right upper limb hand-back maneuver scores for patients in the PT and PT+LI groups were significantly higher when compared to patients who received LI therapy alone (p=0.013,p=0.016 respectively) at 1 month and 3 months post-intervention. Left upper limb hand-back maneuver scores, we well as hand-mouth maneuver scores were comparable between all study group at all follow-up points.
- Analgesic use was comparable between patients in all study groups. 4 patients in the PT+LI group and 2 patients in the LI group experienced localized hematomas. One participant in the LI group reported minimal bleeding; there were no complications recorded in the PT group.
最も覚えておくべきことは？
For patients with myofascial pain syndrome (MPS), treatment via physiotherapy alone, lidocaine injection therapy alone, or combination therapy (physiotherapy and lidocaine injection) resulted in comparable outcomes at all relevant primary and secondary measures when measured at one and three months post-treatment.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that physical therapy and lidocaine injection combination therapy may be similarly effective in improving pain, function, and quality of life outcomes when compared to patients who received either monotherapy at all follow-up points. Future randomized controlled trials with larger patient populations and more patient-focused functional outcomes should be conducted in order to corroborate this study's findings.
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