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Patellar TendinopathyNCT06705881

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

A study testing Eccentric exercise program (EEP) and ESWT (Extracorporeal Shock Wave Therapy) in people with Patellar Tendinopathy and Patellar Tendon Pain, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Patellar Tendinopathy, Patellar Tendon Pain
What is being tested?
Eccentric exercise program (EEP) and ESWT (Extracorporeal Shock Wave Therapy)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2024to 17 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ahi Evran University

    Kırşehir, Center, 40100

Other trials in Turkey (Türkiye)

About this study

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).

Being tested
Eccentric exercise program (EEP), ESWT (Extracorporeal Shock Wave Therapy)
Keywords
exercise, Extracorporeal shock waves therapy, pain, patellar tendinopathy
Medical subject headings
Motor Activity, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06705881
Study groupRoleWhat they receive
Control GroupActive comparatorNot described
Receives: Other: Eccentric exercise program (EEP)
Intervantion GroupExperimentalNot described
Receives: Other: Eccentric exercise program (EEP); Other: ESWT (Extracorporeal Shock Wave Therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sociodemographic Assessment

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

    Measured: Baseline

  2. Visual Analog Scale (VAS)

    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).

    Measured: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

  3. VISA-P Questionnaire

    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.

    Measured: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

  4. Maximal vertical jump test

    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.

    Measured: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

  5. Single-leg hop distance test (SLHD)

    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

    Measured: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

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

    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).

    Measured: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

Secondary outcomes (4)
  1. Tegner Activity Scale (TAS)

    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.

    Measured: Baseline

  2. Pain Catastrophizing Scale

    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.

    Measured: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

  3. Tampa Kinesiophobia Scale

    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.

    Measured: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

  4. Quality of Life (SF-12)

    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.

    Measured: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start1 Dec 2024
  3. Primary completion17 Jul 2025
  4. Study completion17 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06705881
Sponsor's protocol ID
2024/1012
Status last verified
Oct 2026
First submitted
23 Nov 2024
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Breda SJ, Oei EHG, Zwerver J, Visser E, Waarsing E, Krestin GP, de Vos RJ. Effectiveness of progressive tendon-loading exercise therapy in patients with patellar tendinopathy: a randomised clinical trial. Br J Sports Med. 2021 May;55(9):501-509. doi: 10.1136/bjsports-2020-103403. Epub 2020 Nov 20.

    PubMed 33219115

Questions about this trial

What is this clinical trial studying?

A study testing Eccentric exercise program (EEP) and ESWT (Extracorporeal Shock Wave Therapy) in people with Patellar Tendinopathy and Patellar Tendon Pain, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sociodemographic Assessment (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06705881, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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