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

NCT ID: NCT06705881

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-09-01

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).

Conditions

Patellar Tendinopathy; Patellar Tendon Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

Group Type: ACTIVE_COMPARATOR

Eccentric exercise program (EEP)

Intervention Type: 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.

Intervantion Group

Group Type: EXPERIMENTAL

Eccentric exercise program (EEP)

Intervention Type: 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)

Intervention Type: 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.

Interventions

Eccentric exercise program (EEP)

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.

Intervention Type: OTHER

ESWT (Extracorporeal Shock Wave Therapy)

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahi Evran University Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Abdulhamit Tayfur

physiotherapist/assist prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahi Evran University

Kırşehir, Center, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Abdulhamit TAYFUR, PhD

Role: CONTACT

abdulhamit.tayfur@ahievran.edu.tr

507 538 3162 ext. +90

Facility Contacts

Abdulhamit TAYFUR, PhD

Role: primary

abdulhamit.tayfur@ahievran.edu.tr

507 538 3162 ext. +90

References

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.

Reference Type: RESULT

PMID: 33219115 (View on PubMed)

Other Identifiers

2024/1012

Identifier Type: -

Identifier Source: org_study_id