Therapeutic ultrasound for carpal tunnel syndrome

  • Review
  • Intervention

Authors


Abstract

Background

Therapeutic ultrasound may be offered to people experiencing mild to moderate symptoms of carpal tunnel syndrome (CTS). The effectiveness and duration of benefit of this non-surgical intervention remain unclear.

Objectives

To review the effects of therapeutic ultrasound compared with no treatment, placebo or another non-surgical intervention in people with CTS.

Search methods

On 27 November 2012, we searched the Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL (2012, Issue 11 in The Cochrane Library), MEDLINE (January 1966 to November 2012), EMBASE (January 1980 to November 2012), CINAHL Plus (January 1937 to November 2012), and AMED (January 1985 to November 2012).

Selection criteria

Randomised controlled trials (RCTs) comparing any regimen of therapeutic ultrasound with no treatment, a placebo or another non-surgical intervention in people with CTS.

Data collection and analysis

Two review authors independently selected trials for inclusion, extracted data and assessed the risk of bias in the included studies. We calculated risk ratio (RR) and mean difference (MD) with 95% confidence intervals (CIs) for primary and secondary outcomes. We pooled results of clinically homogenous trials in a meta-analysis using a random-effects model, where possible, to provide estimates of the effect.

Main results

We included 11 studies including 414 participants in the review. Two trials compared therapeutic ultrasound with placebo, two compared one ultrasound regimen with another, two compared ultrasound with another non-surgical intervention, and six compared ultrasound as part of a multi-component intervention with another non-surgical intervention (for example, exercises and splint). The risk of bias was low in some studies and unclear or high in other studies, with only two reporting that the allocation sequence was concealed and six reporting that participants were blinded. Overall, there is insufficient evidence that one therapeutic ultrasound regimen is more efficacious than another. Only two studies reported the primary outcome of interest, short-term overall improvement (any measure in which patients indicate the intensity of their complaints compared with baseline, for example, global rating of improvement, satisfaction with treatment, within three months post-treatment). One low quality trial with 68 participants found that when compared with placebo, therapeutic ultrasound may increase the chance of experiencing short-term overall improvement at the end of seven weeks treatment (RR 2.36; 95% CI 1.40 to 3.98), although losses to follow-up and failure to adjust for the correlation between wrists in participants with bilateral CTS in this study suggest that this data should be interpreted with caution. Another low quality trial with 60 participants found that at three months post-treatment therapeutic ultrasound plus splint increased the chance of short-term overall improvement (patient satisfaction) when compared with splint alone (RR 3.02; 95% CI 1.36 to 6.72), but decreased the chance of short-term overall improvement when compared with low-level laser therapy plus splint (RR 0.87; 95% CI 0.57 to 1.33), though participants were not blinded to treatment, it was unclear if the random allocation sequence was adequately concealed, and there was a potential unit of analysis error. Differences between groups receiving different frequencies and intensities of ultrasound, and between ultrasound as part of a multi-component intervention versus other non-surgical interventions, were generally small and not statistically significant for symptoms, function, and neurophysiologic parameters. No studies reported any adverse effects of therapeutic ultrasound, but this outcome was only measured in three studies. More adverse effects data are required before any firm conclusions on the safety of therapeutic ultrasound can be made.

Authors' conclusions

There is only poor quality evidence from very limited data to suggest that therapeutic ultrasound may be more effective than placebo for either short- or long-term symptom improvement in people with CTS. There is insufficient evidence to support the greater benefit of one type of therapeutic ultrasound regimen over another or to support the use of therapeutic ultrasound as a treatment with greater efficacy compared to other non-surgical interventions for CTS, such as splinting, exercises, and oral drugs. More methodologically rigorous studies are needed to determine the effectiveness and safety of therapeutic ultrasound for CTS.

Resumo

Terapia ultrassônica para síndrome do túnel do carpo

Introdução

O ultrassom terapêutico pode ser usado em pessoas com sintomas leves a moderados da síndrome do túnel do carpo (STC). A efetividade e a duração dos benefícios dessa intervenção não cirúrgica permanecem incertos.

Objetivos

Revisar os efeitos da terapia ultrassônica, comparada com nenhum tratamento, placebo ou outra intervenção não cirúrgica em pacientes com STC.

Métodos de busca

As buscas foram realizadas nas seguintes bases de dados, em 27 de novembro de 2012: Cochrane Neuromuscular Disease Group Specialized Register, CENTRAL (2012, Issue 11 in The Cochrane Library), MEDLINE (janeiro de 1966 a novembro de 2012), Embase (janeiro de 1980 a novembro de 2012), CINAHL Plus (janeiro de 1937 a novembro de 2012), and AMED (janeiro de 1985 a novembro de 2012).

Critério de seleção

Ensaios clínicos randomizados comparando qualquer tipo de terapia ultrassônica versus nenhum tratamento, placebo ou outra intervenção não cirúrgica em pacientes com STC.

Coleta dos dados e análises

Dois autores, trabalhando de forma independente, selecionaram os estudos para inclusão, extraíram os dados e avaliaram o risco de viés dos estudos incluídos. Calculamos os riscos relativos (RR) e as diferenças médias (MD), juntamente com os intervalos de confiança de 95% (CI) para os desfechos primários e secundários. Para obter estimativas de efeito, quando possível, combinamos os resultados de estudos clinicamente homogêneos em metanálises usando o modelo de efeitos randômicos.

Principais resultados

Incluímos 11 estudos com 414 participantes nesta revisão. Dois estudos comparavam terapia ultrassônica versus placebo, dois comparavam diferentes protocolos ultrassônicos entre si, dois comparavam ultrassom versus outra intervenção não cirúrgica e seis comparavam ultrassom como parte de uma intervenção multifacetada versus outra intervenção não cirúrgica (por exemplo, exercícios e uso de tala). O risco de viés foi baixo em alguns estudos e incerto ou alto em outros estudos. Apenas dois estudos relatavam o uso de ocultação da sequência de alocação e seis estudos relatavam cegamento dos participantes. No geral, existe evidência insuficiente de que um protocolo de terapia ultrassônica seja mais eficaz que outro. Apenas dois estudos reportaram o desfecho primário de interesse, que era a melhora geral a curto prazo. Essa melhora geral foi medida usando qualquer instrumento para avaliar a intensidade das queixas do paciente antes e depois do tratamento, como por exemplo, a avaliação global de melhora ou a satisfação com o tratamento dentro dos primeiros três meses de terapia. Um estudo de baixa qualidade com 68 participantes encontrou que, quando comparado com placebo, a terapia ultrassônica aumentou a chance de o paciente ter uma melhora geral a curto prazo no final de sete semanas de tratamento (RR 2,36; 95% CI 1,40 a 3,98). Porém, esse resultado deve ser interpretado com cautela devido às perdas de seguimento dos participantes e ao fato de os autores do estudo não terem feito ajustes para a correlação entre os punhos nos participantes com STC bilateral. Um outro estudo com baixa qualidade e com 60 participantes concluiu que o tratamento com ultra-som mais uso de tala por três meses aumentou a melhora geral a curto prazo (satisfação do paciente) quando comparado com o uso isolado de tala (RR 3,02; 95% CI 1,36 a 6,72). Por outro lado, o ultrassom mais tala diminuiu (de forma não significativa) a melhora a curto prazo quando comparado com laser-terapia de baixa intensidade associada ao uso da tala (RR 0,87; 95% CI 0,57 a 1,33). Porém, não houve cegamento dos participantes para o tratamento, os autores não deixaram claro se houve sigilo da sequência de alocação e houve um possível erro de unidade de análise. O uso de diferentes frequências e intensidade de ultrassom produziu diferenças pequenas e sem significância estatística em relação aos sintomas, à função e aos parâmetros neurofisiológicos. O mesmo foi observado na comparação do ultrassom como parte de uma intervenção multifacetada versus outras intervenções não cirúrgicas. Nenhum estudo relatou efeitos adversos associados ao uso da terapia ultrassônica, mas esse desfecho foi medido em apenas três estudos. Mais dados sobre efeitos adversos são necessários antes de se chegar a uma conclusão definitiva em relação à segurança da terapia ultrassônica.

Conclusão dos autores

Existem apenas evidências de baixa qualidade, provenientes de estudos com dados muito limitados, sugerindo que a terapia ultrassônica pode ser mais efetiva que o placebo para melhora de sintomas, a curto e a longo prazo, em pessoas com STC. Não há evidência suficiente sobre a superioridade de nenhum protocolo específico de terapia ultrassônica ou para apoiar o uso do ultrassom como sendo um tratamento mais efetivo do que outras intervenções não cirúrgicas para STC, tais como o uso de talas, exercícios e medicamentos orais. São necessários mais estudos com boa metodologia para avaliar a efetividade e segurança da terapia ultrassônica para STC.

Notas de tradução

Tradução do Centro Cochrane do Brasil (Mariana Vendramin Mateussi)

アブストラクト

手根管症候群に対する超音波療法

背景

超音波療法は、手根管症候群(CTS)で軽度から中等度の症状が認められる患者に対して実施されることがある。この非外科的介入治療の有効性および利益をもたらす期間は不明なままである。

目的

CTS患者を対象として超音波療法を無治療、プラセボまたはその他の非外科的介入治療と比較した効果を評価すること。

検索戦略

2012年11月27日にCochrane Neuromuscular Disease Group Specialized Register、CENTRAL(2012年、The Cochrane Library 第11号)、MEDLINE(1966年1月~2012年11月)、EMBASE(1980年1月~2012年11月)、CINAHL Plus(1937年1月~2012年11月)およびAMED(1985年1月~2012年11月)を検索した。

選択基準

CTS患者を対象として超音波療法(刺激条件を問わない)を無治療、プラセボまたはその他の非外科的介入治療と比較したランダム化比較試験(RCT)。

データ収集と分析

2名のレビューアが独立して選択基準に適合する試験を選出し、データを抽出、試験のバイアスのリスクを評価した。主要アウトカムおよび副次的評価項目について相対リスク(RR)および平均差(MD)を95%信頼区間(CI)とともに算出した。臨床上同質とみなされた試験については、可能な限り治療効果の推定値を求めるためランダム効果モデルを用いてメタアナリシスを実施し、試験結果を統合した。

主な結果

414例を対象とした11試験をレビューに含めた。超音波療法をプラセボと比較した試験が2件、刺激条件が異なる超音波療法を比較した試験が2件、超音波療法とその他の非外科的介入治療を比較した試験が2件、複数の介入治療の一環として実施された超音波療法をその他の非外科的介入治療(運動療法、スプリントなど)と比較した試験が6件であった。バイアスのリスクは数件の試験では低かったが、それ以外の試験では不明もしくは高かった。割り付け順序の隠蔵化が明記されていたのは2件のみであり、参加者の盲検化が記されていたのは6件のみであった。全体的にみて、特定の刺激条件下の超音波療法が他よりも優れているとするエビデンスは不十分であった。対象とした主要アウトカム、すなわち短期の全般的改善度(患者の主訴の強さをベースラインと比較した何らかの測定尺度。例えば、治療後3カ月以内における全般改善評価、治療満足度)について記載があったのは2試験のみであった。68例を対象とした1試験(試験の質:低)では、超音波療法は、プラセボに比べて治療開始7週目における短期の全般的改善度が上がる可能性が示された(RR 2.36、95% CI 1.40~3.98)。しかし、この試験では追跡不能例があり、両側性CTS患者の手首間で相関の補正不備があったためデータは慎重に解釈すべきであろう。もう一方の60例を対象とした試験(試験の質:低)では、超音波療法+スプリント併用は、スプリント単独に比べて治療終了後3カ月目における短期の全般的改善度(患者満足度)が上がる可能性が示された(RR 3.02、95% CI 1.36~6.72)。しかし、超音波療法+スプリント併用を低レベルレーザー療法+スプリント併用と比較した場合、短期の全般的改善度が上がる可能性は低くなった(RR 0.87、95% CI 0.57~1.33)。ただし、参加者は治療の盲検化がなされておらず、ランダム化の割り付け順序が十分に隠蔵化されていたかどうかは不明であり、解析エラーの可能性も残されている。異なる周波数および強度で超音波療法を実施した群間の差、超音波療法が複数の介入治療の一環として実施されたのか、他の非外科的介入治療として実施されたのかという差は概して小さく、症状、機能および神経生理学的パラメーターについて統計学的な有意差は認められなかった。超音波療法の有害作用が報告された試験はなかったが、そもそも3試験でしか評価されていなかった。超音波療法の安全性について確固たる結論を出す前に、有害作用に関するデータを集積する必要がある。

著者の結論

データが非常に限定的で、質の低いエビデンスしか得られなかったが、CTSに対する超音波療法が短期または長期の症状改善面でプラセボよりも有効である可能性が示された。ある刺激条件の超音波療法が他の刺激条件に比較して利益がある、または治療としての超音波療法がCTSに対する他の非外科的介入治療(スプリント、運動療法および経口薬など)よりも有効であることを示すエビデンスは不十分であった。CTSに対する超音波療法の有効性および安全性を判断するには、方法論的に厳密な試験の実施が求められる。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2016.8.9]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Plain language summary

Therapeutic ultrasound for carpal tunnel syndrome

Carpal tunnel syndrome is a condition where one of two main nerves in the wrist is compressed, which can lead to pain in the hand, wrist and sometimes forearm, and numbness and tingling in the thumb, index and long finger. In advanced cases some of the muscles of the hand can become weak. Carpal tunnel syndrome is more common in women and older age groups. Many people undergo surgery to treat this condition, though sometimes other treatments, such as therapeutic ultrasound, are offered. Therapeutic ultrasound involves applying a round-headed instrument to the skin of the painful area, to deliver sound waves that are absorbed by the underlying tissues, to help relieve pain and lessen disability. We searched for study reports and found 11 randomised controlled trials including 443 participants overall that assessed the safety and benefit of therapeutic ultrasound for people with carpal tunnel syndrome. The risk of bias of studies was low in some studies and unclear or high in others. There is only poor quality evidence from very limited data to suggest that therapeutic ultrasound may be more effective than placebo for either short- or long-term symptom improvement in people with carpal tunnel syndrome. There is insufficient evidence to support the greater benefit of one type of therapeutic ultrasound regimen over another or to support the use of therapeutic ultrasound as a treatment with greater efficacy compared with other non-surgical interventions for carpal tunnel syndrome, such as splinting, exercises, and oral drugs. Few studies measured adverse effects to therapeutic ultrasound. More research is needed to find out how effective and safe therapeutic ultrasound is for people with carpal tunnel syndrome, particularly in the long term.

எளியமொழிச் சுருக்கம்

மணிக்கட்டு குகை நோய் தொகுப்புக்கு (carpal tunnel syndrome) சிகிச்சைக்குரிய செவியுணரா ஒலி (ultrasound)

மணிக்கட்டு குகை வழியாக செல்லும் இரண்டு பிரதான நரம்புகளுள் ஒன்று அழுத்தப்படுவதால், கை,மணிக்கட்டு, சிலநேரங்களில் முன்கை, கட்டைவிரல், ஆள்காட்டி விரல் மற்றும் நடு விரல் ஆகியவற்றில் கூச்ச உணர்வு, உணர்வின்மை மற்றும் வலி போன்றவை ஏற்படும் பொதுவான நிலையே மணிக்கட்டு குகை நோய் தொகுப்பு (Carpal tunnel syndrome) ஆகும். முற்றிய நிலையில் சிலருக்கு கை தசைகள் பலவீனமாகலாம். பொதுவாக பெண்கள் மற்றும் வயதானவர்களுக்கு மணிக்கட்டு குகை நோய் தொகுப்பு உண்டாகிறது. பலர் இதற்கு அறுவை சிகிச்சை மேற்கொள்கிறார்கள். இருப்பினும் சிலவேளைகளில் சிகிச்சைக்குரிய செவியுணரா ஒலி (ultrasound) போன்ற மற்ற சிகிச்சை முறைகளும் அளிக்கப்படுகிறது. சிகிச்சைக்குரிய செவியுணராஒலி சிகிச்சையில் ஒரு வட்ட வடிவ கருவி மூலம் வலியுள்ள பகுதியில் உள்ள தோல் வழியாக ஒலிஅலைகள் அனுப்பப்படுகிறது. அடித்தளத்தில் உள்ள திசுக்கள் இந்த ஒலி அலைகளை உறிஞ்சி வலி மற்றும் இயலாமையைக் குறைக்க உதவும். சிகிச்சைக்குரிய செவியுணரா ஒலியின் (ultrasound) பாதுகாப்பு மற்றும் பயனை மதிப்பீடு செய்த 443 பங்கேற்பாளர்கள் கொண்ட 11 சமவாய்ப்பு கட்டுப்பாட்டு சோதனைகளை நாங்கள் தேடி கண்டறிந்தோம். சேர்க்கப்பட்டுள்ள ஆய்வுகள் சிலவற்றில் சார்பு ஆபத்து (risk of bias) குறைவாகவும், மற்றவற்றில் தெளிவற்றும் அல்லது அதிகமாகவும் இருந்தது. மணிக்கட்டுக் கால்வாய் கூட்டறிகுறி கொண்டவர்கள் சிகிச்சைக்குரிய செவியுணரா ஒலி, மருந்துப்போலியைக் காட்டிலும் குறுகிய அல்லது நீண்ட கால அறிகுறி மாற்றங்கள் உண்டுபண்ணுவதில் மிகவும் பயனுள்ளதாக இருக்கும் என்பதற்கு மிகவும் வரையறுக்கப்பட்ட தரவுகளில் இருந்து பெறப்பட்ட குறைந்த தர ஆதாரங்கள் மட்டுமே உள்ளன. மணிக்கட்டு குகை நோய் தொகுப்புக்கு சிகிச்சைக்குரிய செவியுணரா ஒலி சிகிச்சை அளிப்புத் திட்டம் மற்றொரு திட்டத்தை விட பெருவாரியாக பயன்அளிக்கும் என்பதற்கு ஆதரவாகவோ அல்லது சிம்பு அணிதல், உடற்பயிற்சி, வாய்வழி மருந்துகள் போன்ற அறுவை சிகிச்சை அல்லாத தலையீடுகளோடு ஒப்பிடுகையில் சிகிச்சைக்குரிய செவியுணரா ஒலி சிகிச்சை பெருமளவு பயனூட்டு கொண்ட சிகிச்சையாக பயன்படுத்தலுக்கு ஆதரவாகவோ, போதுமான சான்றுகள் இல்லை. சிகிச்சைக்குரிய செவியுணரா ஒலியின் (ultrasound) பக்க விளைவுகளை சில ஆராய்ச்சிகள் மட்டுமே அளவிட்டன. மணிக்கட்டு குகை நோய் தொகுப்பு உள்ளவர்களுக்கு சிகிச்சைக்குரிய செவியுணரா ஒலி (ultrasound) குறிப்பாக நீண்டகால அடிப்படையில் திறனானது மற்றும் பாதுகாப்பானது என்று கண்டறிய மேலும் ஆராய்ச்சிகள் தேவை.

மொழிபெயர்ப்பு குறிப்புகள்

மொழிபெயர்ப்பு: சி.இ.பி.என்.அர்

Resumo para leigos

Ultrassom para síndrome do túnel do carpo

A síndrome do túnel do carpo é uma condição na qual um dos dois principais nervos do punho é comprimido, fazendo com que a mão, o punho e, às vezes, o antebraço fiquem doloridos. Além disso, podem ocorrer dormência e formigamento no polegar, indicador e dedo médio. Nos casos mais graves, pode haver perda de força de alguns músculos da mão. A síndrome do túnel do carpo é mais comum em mulheres e em pessoas mais idosas. Muitas pessoas acabam sendo operadas para tratar desse problema. Porém, às vezes, as pessoas podem ser tratadas sem cirurgia, por exemplo com ultrassom. A terapia com ultrassom (terapia ultrassônica) é feita passando a ponta arredondada (transdutor) de um aparelho de ultrassom na área dolorosa. Esse instrumento emite ondas sonoras que são absorvidas pelo tecido que está embaixo e que servem para ajudar a aliviar a dor e diminuir a disfunção. Nós procuramos por estudos sobre isso e encontramos 11 ensaios clínicos randomizados envolvendo 443 participantes ao todo. Esses estudos avaliaram a segurança e os benefícios do ultrassom para pessoas com síndrome do túnel do carpo. Em alguns estudos, o risco de viés do estudo (que indica a qualidade) foi baixo e, em alguns outros estudos, esse risco de viés foi incerto ou alto. Existe apenas evidência de qualidade baixa, proveniente de estudos com dados bastante limitados, sugerindo que o ultra-som pode ser mais efetivo do que um placebo (medicamento falso) na melhora dos sintomas da síndrome do túnel do carpo a curto ou a longo prazo. Não existe evidência suficiente mostrando que um tipo de regime da ultrassom seja melhor do que outro ou que o ultrassom seja um tratamento mais eficiente do que outras intervenções não cirúrgicas para a síndrome do túnel do carpo, tais como o uso de talas, exercícios e comprimidos. Poucos estudos mediram os efeitos adversos do tratamento com ultrassom. Mais pesquisas são necessárias para descobrir qual é a eficiência e a segurança do ultrassom no tratamento de pessoas com síndrome do túnel do carpo, particularmente a longo prazo.

Notas de tradução

Tradução do Centro Cochrane do Brasil (Mariana Vendramin Mateussi)

平易な要約

手根管症候群に対する超音波療法

手根管症候群は、手首の中を走る2本の主な神経のうち1本が圧迫されて手、手首、ときに前腕に痛みが生じ、親指、人差し指および中指にしびれ、ピリピリ感が起こる。進行した例では、手の筋力が低下することもある。手根管症候群は女性および高齢者によくみられる疾患である。多くは治療のため手術を受けるが、超音波療法をはじめとする他の治療を受ける場合もある。超音波療法では、痛みのある患部に先の丸い器具を当て、深部組織に吸収される音波を到達させることで痛みを緩和し、機能障害を軽減する。試験報告を検索したところ、手根管症候群に対する超音波療法の安全性および有益性を評価した11件のランダム化比較試験(RCT)(総参加者数443例)を認めた。バイアスのリスクは数件の試験では低かったが、それ以外の試験では不明もしくは高かった。データが非常に限定的で、質の低いエビデンスしか得られなかったが、手根管症候群に対する超音波療法が短期または長期の症状改善面でプラセボよりも有効である可能性が示された。ある刺激条件の超音波療法が他の刺激条件に比較して利益がある、または治療としての超音波療法が手根管症候群に対する他の非外科的介入治療(スプリント、運動療法および経口薬など)よりも有効であることを示すエビデンスは不十分であった。音波療法の有害作用を評価した試験は少なかった。手根管症候群に対する超音波療法の有効性および安全性を明らかにするには、特に長期の研究を重ねていく必要がある。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2016.8.9]
《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

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