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

Overview

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).

Interventions

• Other 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). Th
• 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

Primary outcome measures

• Sociodemographic Assessment [Time frame: Baseline]
• Visual Analog Scale (VAS) [Time frame: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]
• VISA-P Questionnaire [Time frame: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]
• Maximal vertical jump test [Time frame: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]
• Single-leg hop distance test (SLHD) [Time frame: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]
• Incline board single-leg squat test (EET) [Time frame: Baseline, 3 week, 6 week, 3 month, 6 month, 12 month]

Secondary outcome measures (4)

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Ahi Evran University — Kırşehir

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. PMID 33219115

Identifiers

NCT: NCT06705881 · 2024/1012

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗