Efficacy of Radial Shockwave Therapy for Treatment of Pain in Knee Osteoarthritis
調査の概要
詳細な説明
- Prospective, placebo controlled randomized and double-blind study.
- Treatment Method:
Radial extracorporeal shockwaves will be applied using the Swiss Dolorclast (EMS Electro Medical Systems, Switzerland), generated by pneumatic waves.
Intervention:
- Group 1 - Intervention group Patients will receive 2,000 impulses of radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
- Group 2 - Control Group:
Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity. Frequency of 8Hz will appear in the screen. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
Post application program for both groups: Three consecutive days of:
- Hot packs (superficial heat) applied on the application site for 20 minutes;
- Simple analgesics, when needed (Acetaminophen 500mg every 6 hours, or analogue in case of allergy).
Outcome Evaluation:
The evaluation of pain intensity will be done according to the VAS (Visual Analog Scale) The influence of pain on the functional capacity of patients will be measured with WOMAC (Western Ontario and McMaster Osteoarthritis Index) for knee evaluation.
Another evaluation criteria will be the level of tolerance of pressure on several muscles and other parts as the pes anserinus and patellar tendon, the knee joint interface, and the supraspinal of L1 to S1 also on the dermatomal from T12 to S2. These measures will be done by the Fisher algometry.
The evaluations will be carried out before the treatment, immediately after the treatment and 3 months after the end of the treatment.
Analgesia drut will be prescribed, if patients feel pain during the days after the application.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Sao Paulo、ブラジル、05716-150
- Instituto de Medicina Fisica e Reabilitacao HCFMUSP
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Sao Paulo、ブラジル、05403-010
- Instituto de Ortopedia e Traumatologia HCFMUSP
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Clinical and radiological diagnosis of primary knee diagnosis.
- Pain intensity: Visual Analog Scale (VAS) ≥ 6;
- One of more failures with conventional treatment (drugs, Non-Steroidal Anti-inflammatory Drugs - NSAD, physiotherapy, stretching, acupuncture, orthosis and others);
- Age over 60 years;
- No use of corticosteroids in the prior 48 hours;
- No major osteoarthritis events in other joints of lower limbs (waist and ankle) and lower back;
- No clinical evidence of related neuropathy, including radiculopathy and peripheral neuropathy;
- Absence of systemic inflammatory disease (Rheumatoid arthritis, Reiter, ankylosing spondylitis, generalized polyarthritis, cancer);
- Absence of infection or cancer at the application site;
- Absence of related endocrine and metabolic diseases;
- Absence of fibromyalgia, diagnosed after the American College of Rheumatology, 1999;
- Absence of severe blood dyscrasias;
- Absence of severe psychiatric disturbances that requires psychiatric assessment;
- Availability to comply with the clinic visits and follow up evaluations along the treatment
Exclusion Criteria:
- Patients who withdraw the informed consent form at any time
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Extracorporeal radial shockwaves
Patients will receive 2,000 impulses of extracorporeal radial shockwave per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz.
The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
|
Patients will receive 2,000 impulses of extracorporeal radial shockwaves or per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz.
The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
|
|
プラセボコンパレーター：Placebo Radial Shockwaves
Patients will receive 2,000 impulses of placebo radial shockwave per week, without any energy flow intensity.
Frequency of 8Hz will appear in the screen.
The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
|
Patients will receive 2,000 impulses of placebo extracorporeal radial shockwaves per week, without any pressure, therefore no energy will be applied, at the frequency of 8Hz.
The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Visual Analog Scale
時間枠：Before intervention and after 3 months of the end of intervention
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The Visual Analog Scale consists of a straight line of 10cm length which presents the phrase "absence of pain" (0) at one extremity, and unbearable pain (10) at the other extremity.
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Before intervention and after 3 months of the end of intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Level of tolerance of pain
時間枠：Immediately before the intervention, immediately after the intervention and 3 months after the intervention.
|
Measures will be taken with the Fisher algometry in the following muscles: vastus medialis, vastus lateralis, rectus femoris, gracilis, adductor longus, tibialis anterior, fibularis longus, quadratus lumborum, iliopsoas and popliteus; also at the pes anserinus and patellar tendon, the knee joint interface, the supraspinal of L1 to S1 and on the dermatomal from T12 to S2.
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Immediately before the intervention, immediately after the intervention and 3 months after the intervention.
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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The influence of pain over the functional capacity of patients based on the WOMAC questionnaire
時間枠：Immediately before the intervention and 3 months after the intervention.
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Immediately before the intervention and 3 months after the intervention.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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