Incorporation of Photobiomodulation Therapy in an Exercise Program With Blood Flow Restriction for Knee Osteoarthritis
2020年1月29日 更新者：Cid André Fidelis de Paula Gomes、University of Nove de Julho
Knee osteoarthritis (OA) is one of the most common musculoskeletal disorders in the world.
The aim of this project is to evaluate the additional effect of photobiomodulation therapy on the quadriceps muscle and knee joint in a blood flow restriction exercise program for individuals with knee OA.
To this end, volunteers will be selected at random, aged between 40 and 65 years with pain in one knee, at least in the last 6 months, diagnosed with unilateral knee OA based on the criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification, will be randomized into the following groups: (Exercises with blood flow restriction, n = 20), (Exercises with blood flow restriction + photobiomodulation, n = 20) and Exercises with blood flow restriction + placebo photobiomodulation (n = 20).
12 consecutive weeks of treatment will be carried out, with the volunteers being evaluated before and after, using the following instruments: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), sit and stand test, Timed up and Go (TUG), numerical scale pain assessment (END), pain-to-pressure threshold (LDP), skin temperature: quadriceps musculature, knee joint and maximum voluntary isometric contraction (MVIC) of the muscles: quadriceps, middle gluteus.
For data analysis, normality test will be used to verify the data distribution and statistical test consistent with the appropriate comparisons within and between groups, thus, two factors are considered in the comparisons, time and group.
A significance level of 5% will be adopted.
調査の概要
状態
わからない
研究の種類
介入
入学 (予想される)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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São Paulo、ブラジル、01504-001
- University of Nove de Julho
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- knee pain to at least six months and minimum of 4 points in pain scale
- diagnosis of unilateral knee OA based on criteria established by the American College of Rheumatology and radiographic confirmation for grades 2 or 3 of the Kellgren-Lawrence Classification.
Exclusion Criteria:
- Score on the numerical visual analog of knee pain less than 1 or greater than 8;
- knee trauma;
- Cognitive impairment;
- Psychological disorder;
- Neurological disorder (sensory or motor);
- Cancer;
- Diabetes any acute adverse health condition;
- Signs of hip OA;
- Sings cardiopulmonary disease that could prevent exercise and use of a walking assist device.
- Have undergone any form of treatment involving: physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotectors in the last year.
- If the size of the circumference of the thigh and knee does not allow the proper positioning of the photobiomodulation mesh.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
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アクティブコンパレータ：Exercises with blood flow restriction
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Device: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.
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Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
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実験的：Exercises with blood flow restriction + photobiomodulation
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.Photobiomodulation a mesh composed of multiple diodes containing 50 Infrared LEDs.
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Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
Photobiomodulation therapy is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures that are receptive to photons.
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プラセボコンパレーター：Blood flow restriction exercises + placebo photobiomodulation
Exercise: 10 minutes of heating on a treadmill without changing the inclination and adopting a standardized speed; Supine bridge, Supine unilateral bridge, Flexion of the hip with the knee extended, Knee extension, volunteer in sedation; Prone knee flexion; Squat on the wall associated with isometric contraction; Abduction of the hip, lateral rotation and knee extension in lateral decubitus associated with isometric contraction; Abduction, lateral rotation of the hip, slight knee and hip flexion performing abduction with the feet together: associated with isometric contraction; Abduction of the hip in orthostatic associated with isometric contraction.Devices: The blood flow restriction in mmHg will be performed using a vascular occlusion training manometer, positioned in the thigh inguinal region and inflated to the point where the auscultatory pulse of the tibial artery is interrupted.
Photobiomodulation turned off with a mesh composed of multiple diodes containing 50 Infrared LEDs.
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Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
Placebo photobiomodulation - photobiomodulation device turned off.
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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 |
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Functional pain
時間枠：Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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Stiffness
時間枠：Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Time Frame: Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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Physical functional
時間枠：Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis.
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Change from Baseline in The Western Ontario and McMaster Universities Arthritis Index at 12 weeks
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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 |
|---|---|---|
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Intensity of pain
時間枠：Change from Baseline in The Numerical rating pain scale at 12 weeks
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The Numerical rating pain scale, a simple, easily administered scale evaluates the perceived intensity of pain, using an 11-point scale from 0, representing 'no pain', to 10, which is the 'worst possible pain'.
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Change from Baseline in The Numerical rating pain scale at 12 weeks
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Functional capacity for sitting and standing
時間枠：Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
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sitting-rising test
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Change from Baseline in The Functional capacity for sitting and standing at 12 weeks
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Level of pressure pain
時間枠：Change from Baseline in ThePressure Pain Threshold at 12 weeks
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Pressure Pain Threshold in the knee with algometer dynamometer.
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Change from Baseline in ThePressure Pain Threshold at 12 weeks
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Muscle skin temperature
時間枠：Change from Baseline in the muscle skin temperature at 12 weeks
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Infrared thermography, thermal imaging.
Thermography uses a type of infrared technology that detects and records temperature changes on the surface of the ski.
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Change from Baseline in the muscle skin temperature at 12 weeks
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Maximum voluntary isometric contraction
時間枠：Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
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A portable dynamometer will be used to assess muscle contraction.
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Change from Baseline in the Maximum voluntary isometric contraction at 12 weeks
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協力者と研究者
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2020年11月1日
一次修了 (予想される)
2020年11月1日
研究の完了 (予想される)
2022年12月1日
試験登録日
最初に提出
2020年1月27日
QC基準を満たした最初の提出物
2020年1月27日
最初の投稿 (実際)
2020年1月30日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月31日
QC基準を満たした最後の更新が送信されました
2020年1月29日
最終確認日
2020年1月1日
詳しくは
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