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Clinical Trials/NCT06705881
NCT06705881
Recruiting
Not Applicable

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

Ahi Evran University Education and Research Hospital1 site in 1 country32 target enrollmentDecember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patellar Tendinopathy
Sponsor
Ahi Evran University Education and Research Hospital
Enrollment
32
Locations
1
Primary Endpoint
Sociodemographic Assessment
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
September 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ahi Evran University Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Abdulhamit Tayfur

physiotherapist/assist prof.

Ahi Evran University Education and Research Hospital

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.

Outcomes

Primary Outcomes

Sociodemographic Assessment

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

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

Study Sites (1)

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