Efficacy of the Extracorporeal Shock Wave Therapy in Athletes With Patellar Tendinopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAhi Evran University Education and Research Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Eccentric exercise program (EEP)
Other interventionAll 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 interventionESWT 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Intervantion GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
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
Time frame
Baseline2
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).
Time frame
Baseline, 3 week, 6 week, 3 month, 6 month, 12 month3
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.
Time frame
Baseline, 3 week, 6 week, 3 month, 6 month, 12 month4
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.
Time frame
Baseline, 3 week, 6 week, 3 month, 6 month, 12 monthSecondary outcomes
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.
Time frame
Baseline2
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.
Time frame
Baseline, 3 week, 6 week, 3 month, 6 month, 12 month3
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.
Time frame
Baseline, 3 week, 6 week, 3 month, 6 month, 12 month4
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.
Time frame
Baseline, 3 week, 6 week, 3 month, 6 month, 12 monthSponsors and contacts
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Source ClinicalTrials.gov