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NCT Number: NCT06705881

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahi Evran University

Kırşehir, Center, 40100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Abdulhamit TAYFUR, PhD

CONTACT

[email protected]

507 538 3162 ext. +90

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Eccentric exercise program (EEP)

Other

All participants will perform a 6-week single-leg eccentric squat exercise. It will be performed on an incline board with a 25° incline. It will consist of a single-leg squat, with the downward component (eccentric phase) of the EEP performed using the symptomatic leg and the upward component (concentric phase) using the contralateral leg primarily. If pain occurs during the exercises, athletes will be asked to continue the exercise if they score ≤5 out of 10 on the Visual Acuity Scale (VAS). The exercises will be attempted in the first session of each week, and if no or very little pain is felt, the weight will be increased by 2.5% to increase the intensity of the exercise. Three sets of 15 repetitions per session will be performed twice a day. It will be performed 5 days a week. Participants will be asked to fill out an exercise diary (sets, repetitions, and daily frequency) and return it to the researchers at each follow-up session.

ESWT (Extracorporeal Shock Wave Therapy)

Other

ESWT is a therapy method routinely used in private and public hospitals. Tendinopathy therapy parameters approved by the International Society for Medical Shock Wave Therapy (ISMST) for focused ESWT treatment are: 0.10-0.25 mJ/mm (dosing appropriate to pain), up to a maximum of 5 Hz, 1500-2500 pulses per session, 1-2 weeks apart. Accordingly, in our study, the focused ESWT dosage of the ESWT group will be applied as; 0.10-0.25 mJ/mm (dosing appropriate to pain), 4 Hz, 2000 pulses, 1 session per week for 3 weeks. No exercise will be done on the day of ESWT.

Primary outcomes

  1. Sociodemographic Assessment

    Time frame: Baseline

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

  2. Visual Analog Scale (VAS)

    Time frame: 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).

  3. VISA-P Questionnaire

    Time frame: 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.

  4. Maximal vertical jump test

    Time frame: 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.

  5. Single-leg hop distance test (SLHD)

    Time frame: 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

  6. Incline board single-leg squat test (EET)

    Time frame: 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).

Secondary outcomes

  1. Tegner Activity Scale (TAS)

    Time frame: Baseline

    Tegner activity scale (TAS) is a 1-item instrument that assesses activity levels for sports (competitive or recreational football, basketball, handball, etc.) and occupational activities (light or heavy work). It assesses the patient's work and sports activity level on an 11-level scale, with higher scores representing higher physical activity levels.

  2. Pain Catastrophizing Scale

    Time frame: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

    The participants' pain catastrophizing will be assessed using the "Pain Catastrophizing Scale (PCS)". The Turkish version of the "Pain Catastrophizing Scale", which has been reported to reliably predict certain variables such as fear, emotion or thought related to past pain experiences, severe pain, disability and emotional disturbances, will be assessed using the Pain Catastrophizing Scale. The scale consists of 13 questions scored between 0-4 (0=Not at all, 1=Somewhat. 2=Moderately, 3=Severely, 4=Always). An increase in the scale score indicates a high fear of experiencing pain.

  3. Tampa Kinesiophobia Scale

    Time frame: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

    TKS is a 17-question checklist and is used in acute and chronic low back pain, fibromyalgia, musculoskeletal injuries, and whiplash-related diseases. The scale uses a 4-point Likert score (1= Strongly disagree, 4= Strongly agree). A total score is calculated after reversing items 4, 8, 12, and 16. The person receives a total score between 17-68. A high score on the scale indicates that the person has high kinesiophobia. The validity and reliability of the questionnaire in Turkish was conducted by Tunca Yılmaz and his colleagues. For chronic pain, a change of 5.6 points is considered clinically significant.

  4. Quality of Life (SF-12)

    Time frame: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

    SF-12 consists of 8 sub-dimensions and 12 items: physical functioning (2 items), physical role (2 items), body pain (1 item), general health (1 item), energy (1 item), social functioning (1 item), emotional role (2 items) and mental health (2 items). While the items related to physical and emotional role are answered as dichotomous (yes or no), the other items have Likert-type options ranging from 3 to 6. The total score of the survey ranges from 0 to 100, with a higher score representing better health.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdulhamit TAYFUR, PhD

CONTACT

[email protected]

507 538 3162 ext. +90

Sponsors and collaborators

Lead sponsor

Ahi Evran University Education and Research Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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