Ultrasound-Monitored Changes in Achilles Tendinopathy After Extracorporeal Shock Wave Therapy
The Ultrasound-Monitored Changes in Achilles Tendinopathy After Focused Extracorporeal Shock Wave Therapy - a Randomized Sham-Controlled Trial
This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.
Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the first week, there will be a clinical examination by a physiotherapist, an ultrasonographic examination, and the patient will complete a VISA-A questionnaire. At the end of the examination, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.
調査の概要
詳細な説明
This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.
Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the initial session, there will be a clinical examination by a physiotherapist, which includes case history questions, measuring range of motion (measured by weight-bearing lunge test), functional loading tests (1-leg heel rise test, 1-leg hop test) and an ultrasonographic examination (tendon cross section area and width at the maximal tendon antero-posterior width place). In addition, the patient will complete a VISA-A questionnaire. At the end of the initial session, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Prague、チェコ
- University Hospital Motol and 2nd Faculty of Medicine, Charles University
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- the patient complains about Achilles tendon pain, which limits (at least partially) his quality of life during daily activities or sport, and this condition would be referred as a tendinopathy
- the patient's other leg is asymptomatic
- the patient is not aware of the symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
- the patient has no previous experience with extracorporeal shockwave therapy treatment
Exclusion Criteria:
- the patient has condition which is contraindication for extracorporeal shock wave therapy treatment
- the patient had symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Treatment Group (A)
Group of patients with Achilles tendinopathy which are treated by focused extracorporeal shockwave therapy once a week for 5 weeks.
ESWT parameters: 0,12 mJ/mm2, 10 Hz, 1300 shocks.
|
Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.
|
|
偽コンパレータ：Sham Group (B)
Group of patients with Achilles tendinopathy in which sham extracorporeal shockwave therapy is applied once a week for 5 weeks.
Total applications are 5, applicated weekly.
Sham ESWT parameters are same as in Group A (0,12 mJ/mm2, 10 Hz, 1300 shocks) but with modified applicator which does not allow wave transmission.
|
Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission.
|
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 |
|---|---|---|
|
Change in Cross-sectional Area at the Place of Maximum Tendon Width
時間枠：Change of initial values at 3 weeks follow up after last application (8th week).
|
Measured by measuring tools in ultrasound machine in cm2.
In linear view is selected maximal width place, then the position of ultrasound head is rotated to horizontal view and in this view cross section area is measured.
|
Change of initial values at 3 weeks follow up after last application (8th week).
|
|
Change in Maximum Pain in the Achilles Tendon Area
時間枠：Change in maximum pain in the timeframe of the last application (5th week)
|
Measured by numeric rating scale in points.
The values can reach 0-10 points.
A higher score means worse pain.
|
Change in maximum pain in the timeframe of the last application (5th week)
|
|
Change in Maximum Pain in the Achilles Tendon Area (Follow up)
時間枠：Change in maximum pain at 3 weeks follow up after last application (8th week).
|
Measured by numeric rating scale in points.
The values can reach 0-10 points.
A higher score means worse pain.
|
Change in maximum pain at 3 weeks follow up after last application (8th week).
|
|
Change of Ankle Dorsiflexion Range of Motion
時間枠：Change of initial values at 3 weeks follow up after last application (8th week).
|
Measured using weight-bearing lunge test in cm.
|
Change of initial values at 3 weeks follow up after last application (8th week).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Hypoechogenic Areas
時間枠：Change of the echostructure at 3 weeks follow up after last application (8th week).
|
Echostructure is evaluated visually by investigator using musculoskeletal ultrasound machine.
Patients who have a hypoechogenic areas in the tendon are counted.
|
Change of the echostructure at 3 weeks follow up after last application (8th week).
|
|
Number of Participants With Increased Thickness of Achilles Tendon
時間枠：Change of the tendon continuity at 3 weeks follow up after last application (8th week).
|
The Achilles tendon continuity in evaluated visually by investigator using musculoskeletal ultrasound machine.
Patients who have a visually significant increased thickness of tendon will be counted.
|
Change of the tendon continuity at 3 weeks follow up after last application (8th week).
|
|
Change in VISA-A Questionnaire Score
時間枠：Change of initial values at 3 weeks follow up after last application (8th week).
|
The VISA-A questionnaire is standardized questionnaire for patients with Achilles tendinopathy.
The results are recorded in points (0-100 points).
The higher score indicates patients better condition.
|
Change of initial values at 3 weeks follow up after last application (8th week).
|
|
Change in Single Leg Heel Rise Test
時間枠：Change of initial values at 3 weeks follow up after last application (8th week)
|
Patient performs as many heel rises using only one leg as possible in 30 seconds or until first sign of pain in Achilles tendon area.
|
Change of initial values at 3 weeks follow up after last application (8th week)
|
|
Change in Single Leg Hop Test
時間枠：Change of initial values at 3 weeks follow up after last application (8th week).
|
Patient performs as many hops on one leg as possible in 30 seconds or until first sign of pain in Achilles tendon area.
|
Change of initial values at 3 weeks follow up after last application (8th week).
|
協力者と研究者
捜査官
- 主任研究者：Stanislav Machač, Mgr., Ph.D.、University Hospital Motol and 2nd Faculty of Medicine, Charles University
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
BTL-6000 FSWTの臨床試験
-
Lithuanian University of Health SciencesResearch Council of Lithuania完了
-
Dokuz Eylul UniversityScientific Research Projects完了肩峰下インピンジメント症候群