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

Not Applicable

Recruiting

• Conditions: Patellar Tendinopathy; Patellar Tendon Pain

• Registration Number: NCT06705881
• Lead Sponsor: Ahi Evran University Education and Research Hospital

Brief 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. 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-23
• Study First Submitted QC: 2024-11-23
• Study First Posted: 2024-11-26
• Study Start: 2024-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-07-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sociodemographic Assessment	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)	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	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	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)	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)	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 Outcome Measures

Name	Time	Method
Tegner Activity Scale (TAS)	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.
Pain Catastrophizing Scale	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.
Tampa Kinesiophobia Scale	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.
Quality of Life (SF-12)	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.

Trial Locations

Locations (1)

Ahi Evran University; 🇹🇷 Kırşehir, Center, Turkey