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临床试验/NCT06705881
NCT06705881招募中不适用

Efficacy of the Extracorporeal Shock Wave Therapy in Athletes With Patellar Tendinopathy

Ahi Evran University Education and Research Hospital2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
32
试验地点
2
主要终点
Sociodemographic Assessment

研究概览

简要总结

The aim of this study is to investigate the effectiveness of extracorporeal shock wave therapy (ESWT) in addition to eccentric exercise on the clinical outcomes of PT in the treatment of athletes with patellar tendinopathy (PT). Participants will be randomly divided into two groups. The intervention group will receive focus ESWT 3 times a week in addition to 6 weeks of exercise. The control group will be given 6 weeks of exercise. Evaluations will be made at the 3rd and 6th weeks, and at the 3rd, 6th and 12th months. Patient evaluation will begin with obtaining sociodemographic information. Patients' pain level will be assessed using visual analog scale (VAS), tendon pain and function VISA-P, functional capacity; The patients will be assessed with the maximal vertical jump test (MDS), single leg jump distance test (SLHD), single leg squat test (STS) on the incline board, pain catastrophe with the pain catastrophe scale (PCS), kinesiophobia with the Tampa Kinesiophobia Scale (TKS), quality of life short form-12 (SF-12) and physical activity level with the Tegner Activity Scale (TAS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Localized pain in the inferior pole of the patella during single-leg squatting due to load,
  • Pain or tenderness with palpation of the patellar tendon,
  • Complaints of pain in the patellar tendon due to training, competition or physical activity in the last 6 months,
  • Performing sports/physical activities related to jumping and landing,
  • Professional and recreational athletes who perform at least 5 and above according to the Tegner Activity score,
  • VISA-P scale score <80 out of 100.

排除标准

  • Presence of other knee pathologies,
  • Known presence of inflammatory joint diseases or familial hypercholesterolemia,
  • Daily use of drugs with presumed effects on the patellar tendon (e.g. fluoroquinolones) in the last 12 months,
  • Local injection therapy with corticosteroids in the last 12 months,
  • Previous patellar tendon rupture,
  • Any lower extremity surgery in the last 6 months.

结局指标

主要结局

Sociodemographic Assessment

时间窗: Baseline

Age, gender, height, weight, BMI, sports age, occupation, dominant side, affected side, currently doing sports, did they do sports in the past

Visual Analog Scale (VAS)

时间窗: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

The pain intensity felt by the participants in the knee joint during rest and activity, respectively, will be assessed with VAS. VAS is an easy-to-use scale as it does not have any language and is frequently applied in clinics. Individuals will be asked to describe the pain they feel during the test on a 10 cm scale as "0" (no pain) and "10" (unbearable pain).

VISA-P Questionnaire

时间窗: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

Assess symptom severity, knee function and sports ability in athletes with PT. VISA-P questionnaire consists of 8 questions. The first 6 questions are to assess symptom severity during sports activities and the last 2 questions ask about sports-related knowledge interaction and participation. The maximum score of the first 7 questions of VISA-P questionnaire is 10 points and the last question is 30 points. Theoretically, the maximum score of VISA-P questionnaire is 100 and the minimum score is 0. The maximum VISA score for an asymptomatic athlete is 100 points.

Maximal vertical jump test

时间窗: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

The Vertical Jump Test (vertical jump or upright jump) is a commonly performed fitness test to determine an athlete's leg muscle strength or explosive power. The higher the jump, the stronger an athlete's leg muscle/explosive power. The test will be performed with an Optojump.

Single-leg hop distance test (SLHD)

时间窗: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

The long-distance single-leg hop (SLHD) is the most frequently reported functional test. Participants will be instructed to stand on the leg to be tested, jump as far forward as possible, and land on the same leg. The test procedure will be explained and then demonstrated. Participants will be given a practice run before the main measurement until they become familiar with the test and will be performed three times on both legs, starting with the non-dominant leg. Participants must not have any loss of balance during landing before the jump distance is measured and recorded. Dropping the other foot during the jump or landing, any abnormal movement that causes the supporting leg to move during landing, or touching the ground with the upper extremities will be recorded as a failed attempt. After an unsuccessful attempt, participants will be reminded to maintain balance on the landing leg for two seconds. They will then be allowed to perform a new attempt. The jump test will be considere

Incline board single-leg squat test (EET)

时间窗: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

The incline board single-leg squat test (EET) is recommended as a provocation test to differentiate patellar tendon pain. The single-leg eccentric squat exercise will be performed on an incline board with a 25° incline (Impellizzeri et al., 2007). The EET will consist of a single-leg squat, with the downward component (eccentric phase) performed with the symptomatic leg and the upward component (concentric phase) primarily using the contralateral leg. The original test was described using a 25° incline board to increase the load on the patellar tendon and avoiding flexion beyond 60°. Localized pain at the inferior pole of the patella is identified as an important diagnostic sign for patellar tendinopathy. Participants will be asked to squat to the point of pain and the squat angles will be measured with a goniometer. Pain levels will be recorded with a VAS. A difference of 2 points on the VAS will be considered the minimal clinically important difference (MCID).

次要结局

  • Tegner Activity Scale (TAS)(Baseline)
  • Pain Catastrophizing Scale(Baseline, 3 week, 6 week, 3 month, 6 month, 12 month)
  • Tampa Kinesiophobia Scale(Baseline, 3 week, 6 week, 3 month, 6 month, 12 month)
  • Quality of Life (SF-12)(Baseline, 3 week, 6 week, 3 month, 6 month, 12 month)

研究者

发起方
Ahi Evran University Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdulhamit Tayfur

physiotherapist/assist prof.

Ahi Evran University Education and Research Hospital

研究点 (2)

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