Comparative Effects of Focused and Unfocused (Radial) ESWT in the Treatment of Patellar Tendinopathy.

NCT05423366 | Completed

• 1 other identifier: University of Van YüzüncüYıl
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

There is no scientific study in the literature regarding the use of different extracorporeal shock wave therapies (ESWT) in the treatment of patellar tendinopathy. In this study, we aim to investigate both the effectiveness of ESWT and which type of ESWT can be more effective in the treatment of patellar tendinopathy.

Conditions

Patellar Tendinitis

Outcome Measures

Primary Outcomes (8)

• Visual Analogue Scale (VAS)

  patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse

  at baseline.

• Visual Analogue Scale (VAS)

  patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse

  3 weeks after baseline.

• Visual Analogue Scale (VAS)

  patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse

  7 weeks after baseline.

• Visual Analogue Scale (VAS)

  patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse

  15 weeks after baseline.

• Victorian Institute of Sports Assessment-Patella (VISA-P)

  The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. Theoretically, a maximum score of 100 and a minimum score of 0 can be obtained in the VISA-P questionnaire. Scores below 80 are usually indicative of patellar tendinopathy.

  at baseline.

• Victorian Institute of Sports Assessment-Patella (VISA-P)

  The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. Theoretically, a maximum score of 100 and a minimum score of 0 can be obtained in the VISA-P questionnaire. Scores below 80 are usually indicative of patellar tendinopathy.

  3 weeks after baseline.

• Victorian Institute of Sports Assessment-Patella (VISA-P)

  The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. Theoretically, a maximum score of 100 and a minimum score of 0 can be obtained in the VISA-P questionnaire. Scores below 80 are usually indicative of patellar tendinopathy.

  7 weeks after baseline.

• Victorian Institute of Sports Assessment-Patella (VISA-P)

  The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. Theoretically, a maximum score of 100 and a minimum score of 0 can be obtained in the VISA-P questionnaire. Scores below 80 are usually indicative of patellar tendinopathy.

  15 weeks after baseline.

Study Arms (3)

Large-Focused Extracorporeal Shock Wave Therapy

ACTIVE COMPARATOR

Device: Extracorporeal Shock Wave Therapy (ESWT)

Controlled-Unfocused (Radial) Extracorporeal Shock Wave Therapy

ACTIVE COMPARATOR

Device: Extracorporeal Shock Wave Therapy (ESWT)

Sham Extracorporeal Shock Wave Therapy

SHAM COMPARATOR

Device: Extracorporeal Shock Wave Therapy (ESWT)

Interventions

Extracorporeal Shock Wave Therapy (ESWT) DEVICE

The ESWT device is product of Elettronica Pagani, Italy.

Controlled-Unfocused (Radial) Extracorporeal Shock Wave Therapy; Large-Focused Extracorporeal Shock Wave Therapy; Sham Extracorporeal Shock Wave Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Engaging in active sports, being 18 years or older, history of activity-related knee pain in the patellar tendon or patellar insertion, symptoms lasting longer than 8 weeks (non-acute), VISA-P score less than 80 before treatment, pain during knee loading on tendon or tendon it remains isolated in the limited part of the bone junction and does not spread to the entire patellar region (to differentiate patellar tendinopathy and patellofemoral pain).

You may not qualify if:

• Being under the age of 18, acute knee or acute patellar tendon injury, chronic inflammatory joint diseases (rheumatoid arthritis, etc.), using immunosuppressive or corticosteroid medication in the last 6 months, previous knee surgery (in the anterior cruciate ligament or patellar tendon), knee in the last 1 month local (corticosteroid) injection, contraindications for ESWT treatment (eg pregnancy, malignancy, coagulopathy), previous ESWT treatment

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yuzuncu Yil University

Van, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Volkan Şah

  Yüzüncü Yıl Üniversitesi Tıp Fakültesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: September 16, 2022
• Primary Completion: November 28, 2022
• Study Completion: December 19, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)