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Ultrasound in addition to physical therapy has no significant effect in patients with OA
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PHYSICAL THERAPY & REHAB

Therapeutic ultrasound versus sham ultrasound for the management of patients with knee osteoarthritis: a randomized double-blind controlled clinical study

OrthoEvidence Journal (OE Journal) - ACE Report

OE Journal. 2013;1(12):174 Int J Rheum Dis. 2012 Apr;15(2):197-206. doi: 10.1111/j.1756-185X.2012.01709.x. Epub 2012 Feb 13

42 patients were randomized to receive physical therapy with the addition of either an ultrasound intervention or a sham ultrasound intervention (placebo) to determine the effect of ultrasound therapy in the treatment of knee osteoarthritis. Changes in pain, knee function, ambulation activity, disability and psychological status were measured at the completion of a 3-week intervention program. The results indicated that both groups demonstrated significant improvements; however, there were no differences between the groups. There appears to be no beneficial effect of using ultrasound therapy in addition to conventional physical therapy for the treatment of knee osteoarthritis.


出版資金提供の詳細 +
資金提供:
Non-funded
コンフリクト:
None disclosed

バイアスのリスク

8/10

報告基準

19/20

脆弱性指数

N/A

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

4/4

Outcome Measurements

3/4

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?

Knee osteoarthritis (OA) has been indicated to become one of the global leaders of disability amongst both men and women, and management options are constantly debated. It has been established that a combination of nonpharmacological and pharmacological treatments provide an effective course of management for pain and disability associated with knee OA. However, the clinical efficacy of physical agents such as ultrasound (US) therapy for treatment of muscoloskeletal disorders is controversial, yet popular. A study was needed to evaluate the short-term effectiveness of US therapy versus those who did not receive US therapy.

主な研究課題は何ですか?

Did ultrasound therapy in patients with knee osteoarthritis provide better clinical efficacy after 3 weeks of treatment when compared to placebo-controlled patients?

研究の特徴 +
人口:
42 patients who required treatment for knee osteoarthritis. (n=40 completed follow-up)
介入:
Ultrasound (US) Group: Patients received ultrasound therapy with a Sonopuls 434 ultrasound machine (Enraf Nonius) with a continuous frequency of 1 MHz and intensity of 1W/cm^2 applied with a 5-cm applicator for 10 minutes. Patients also received 20 min of hot packs, 10 min of interferential current, and 15 min of isometric quadriceps exercise. Treatment occurred 5 times weekly for 3 weeks.
比較:
Placebo (sham US) Group: Patients received the same treatment as described above, with the ultrasound machine set to "on" and dials lit up, but no energy was delivered to the knee.
アウトカム:
Improvement in pain was measured on a 100-mm visual analog scale (VAS-pain). Functional improvement was assessed with Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score. Ambulation activity was evaluated with the amount of time needed to walk 50 m. Disability was measured with the Lequesne index questionnaire. Psychological status was assessed using the Hospital Anxiety and Depression Scale (HADS).
方法:
RCT, Double-blind, Placebo-controlled, Prospective
時間:
Follow-up was conducted at the end of the 3-week intervention program.

重要な知見は?

  • Within-group analysis of VAS-pain scores (at rest and with activity) indicated pain was reduced significantly after the program in both groups (both p-values=0.001). However, significant difference after treatment was not demonstrated between groups (US vs. Sham group: VAS at rest = 2.30 vs. 2.95, p=0.319; VAS with activity = 3.30 vs. 4.45, p=0.078).
  • Although significant improvements were seen for both groups after treatment in WOMAC scores for functional ability (p-values=0.001), there was no difference between groups after treatment (p-values>0.196).
  • 50m walking time improved from baseline values (p-values=0.001), but there was no difference between groups at the end of the intervention program (p=0.120).
  • Both groups displayed a significant decrease in average Lequesne index score for disability compared to baseline measures (p<0.05), but the scores did not differ between groups after the intervention (p=0.813).
  • Psychological parameters of anxiety and depression were reduced in both groups after treatment, but there was no difference between groups after intervention (p>0.494).
最も覚えておくべきことは?

The use of ultrasound therapy had no effect/improvement on pain, function, ambulation activity, disability, and psychological status when compared to patients who did not receive ultrasound therapy. It should be noted that both groups demonstrated a significant improvement in pain, stiffness, functional activity, walking time, disability, depression and anxiety scores compared to pre-treatment values.

それが私の患者ケアにどのように影響するか?

This study suggests that there is no beneficial effect of using ultrasound therapy in addition to a traditional physical therapy program for the treatment of knee osteoarthritis. Further studies with larger sample groups should be conducted to investigate if any differences in long-term outcomes exist. Additionally, to provide a better assessment of the effectiveness of ultrasound therapy this treatment should be assessed on its own.

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引用方法 ACE Report

OrthoEvidence. Ultrasound in addition to physical therapy has no significant effect in patients with OA. OE Journal. 2013;1(12):174. Available from: https://myorthoevidence.com/AceReport/Show/ultrasound-in-addition-to-physical-therapy-has-no-significant-effect-in-patients-with-oa

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