Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendinitis

Official title

Clinical Eficacy of Extracorporeal Shock Wave Therapy on Patellar Tendon Combined With Center of Coordination Point in the Fascial Manipulation for Patellar Tendinitis:A Randomized Controlled Trial.

Overview

This study is a randomized controlled trial. Patients diagnosed with patellar tendinitis and meeting the criteria for shockwave therapy were included. Relevant clinical data and assessments were collected upon enrollment and after obtaining informed consent. Randomization was performed using a random number table: the experimental and control groups. Based on the group assignments, the experimental group received either patellar tendon combined with fascial therapy coordinated centre point shock wave treatment, while the control group received only shockwave therapy for the patellar tendon. The treatments were performed by a rehabilitation therapist with extensive clinical experience. Data on participant pain and knee joint function were collected using the Visual Analogue Scale (VAS) and the Lysholm Knee Scoring System at baseline and on the day following completion of all treatments. Data on the thickness of the patellar tendon on the affected side of the knee were collected using a portable musculoskeletal ultrasound imaging system. Follow-up assessments and data collection on pain and knee joint function were conducted using the VAS and Lysholm Knee Scoring Scale one month and three months after the completion of all treatments to compare changes before and after treatment and to evaluate whether patellar tendon combined with fascial therapy coordinated centre point shock wave therapy has superior short-term and medium-term maintenance efficacy for patellar tendinitis compared with simple patellar tendon shock wave therapy.

Interventions

• Procedure Extracorporeal Shock Wave Therapy on Patellar Tendon Combined with Center of Coordination Point
  Extracorporeal shockwave therapy was performed on the patellar tendon (Belgium Gymna Shock Master 500 Extracorporeal Shockwave Therapy Device) with a frequency of 8Hz and energy of 2.0Bar, for a total of 2000 shocks; shockwave therapy was performed at the coordination centre points marked after assessment by a fascia therapist (Belgium Gymna Shock Master 500 Extracorporeal Shockwave Therapy Device) with a frequency of 8Hz and energy of 2.0Bar, for a total of 4000 shocks. The patient underwent a
• Procedure Extracorporeal Shock Wave Therapy only on Patellar Tendon
  Extracorporeal shockwave therapy was performed only on the patellar tendon (Belgium Gymna Shock Master 500 Extracorporeal Shockwave Therapy Device) with a frequency of 8Hz and energy of 2.0Bar, for a total of 6000 shocks.The patient underwent a total of 3 treatment courses, with an interval of 1 week between each course.

Primary outcome measures

• the change in pain intensity over a follow-up period of 3 months after treatment [Time frame: Baseline and Day 105]

Secondary outcome measures (3)

• The changes in pain intensity measured both on the day following treatment and during the follow-up period of one month [Time frame: Baseline, Day 15 and Day 45]
• the changes in the Lysholm knee scoring scale after treatment, as well as during follow-up visits after one and three months. [Time frame: Baseline, Day 15, Day 45 and Day 105]
• the change in the thickness of the patellar tendon on the day following treatment [Time frame: Baseline and Day 15]

Eligibility criteria

Inclusion criteria

• Adults aged between 18 and 45 yearsWillingness to sign an informed consent form and ability to cooperate with the treatment and follow-up aspects of this study.
• Meeting the diagnostic criteria for patellar tendinitis as outlined in "Practical Sports Medicine" (2023 edition)
• Knee joint pain with a VAS score of ≥3 and ≤7
• No other orthopedic or neurological conditions that could affect lower limb strength or mobility
• Willingness to sign an informed consent form and ability to cooperate with the treatment and follow-up aspects of this study

Exclusion criteria

• History of knee joint surgery within the past year
• Presence of knee pain due to other causes, or conditions that affect the knee joint or impact its function (including but not limited to: transient synovitis, bone tuberculosis, bone tumors, acute traumatic arthritis, suppurative arthritis, rheumatoid arthritis, metabolic bone diseases, psoriatic arthritis, gouty arthritis, bone necrosis, ankylosing spondylitis, or active infections)
• Presence of chronic knee pain caused by other reasons (such as post-herpetic neuralgia, osteoporosis, etc.)
• Contraindications for shockwave therapy, such as deep venous thrombosis in the lower extremities, bleeding disorders or coagulation dysfunction, pregnancy, cognitive dysfunction, etc.
• Presence of cancerous tumors, severe bronchiectasis, acute suppurative inflammation, high fever, active pulmonary tuberculosis, heart failure, severe anemia, cerebrovascular diseases, or the presence of a cardiac pacemaker implanted in the body
• Inability to participate in the trial due to other health issues, such as sudden severe trauma, sudden severe infectious diseases, etc.

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

Quadruple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• 中山大学孙逸仙纪念医院 — Guangzhou
• 中山大学孙逸仙纪念医院 — Guangzhou

Identifiers

NCT: NCT07401758 · SYSKY-2025-946-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗