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The effect of radial and focused shockwave therapy on tendon structure in patients with patellar tendinopathy and healthy subjects: a pilot study

The effect of radial and focused shockwave therapy on tendon structure in patients with patellar tendinopathy and healthy subjects: a pilot study - TOPSHOCK UTC-study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41000
Enrollment
60
Registered
2015-01-15
Start date
2015-02-13
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

jumpers knee patellar tendinopathy

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male and female subjects with the following criteria are eligible for inclusion in patellar tendinopathy subject group: - History of knee pain in patellar tendon or its patellar or tibial insertion in connection with training and competition - Symptoms for over three months - Age 18-45 years old - Palpation tenderness to the corresponding painful area - Degenerative tendon changes determined by a regular ultrasound echo - VISA-P score

Exclusion criteria

Exclusion criteria: Subjects must not be included in the patellar tendinopathy subjects group if one of the following applies: - acute knee or patellar tendon injuries - chronic knee joint diseases - signs or symptoms of other coexisting knee pathology - contraindications for SWT (pregnancy, malignancy, coagulopathy) - knee surgery or injection therapy with corticosteroids in the last preceding three months - Daily use of drugs with a putative effect on patellar tendinopathy in the last year (e.g. non-steroid anti-inflammatory drugs, fluorchinolones) or actual use of anticoagulants;Subjects must not be included in the healthy subjects group if one of the following applies: - acute knee or patellar tendon injuries - history of patellar tendinopathy - chronic joint diseases - contraindications for SWT (pregnancy, malignancy, coagulopathy) - daily use of drugs with a putative effect on patellar tendinopathy in the last year (e.g. non-steroid anti-inflammatory drugs, fluorchinolones) or actual use of anticoagulants - Allergy or intolerance for paracetamol

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the echo type percentage of the structure of the patellar tendon determined by the UTC device. The UTC is an imaging technique for tendons. It displays the density and arrangement of the collagenous matrix. The tendon structure can be divided into four different echo types, type I, type II, type III and type IV. Type I and II are considered as organized tendon structure, where type III and IV are considered as degenerative tendon structure.

Secondary

MeasureTime frame
The secondary study parameters are the following: - Self reported VISA-P score: The VISA-P score is a simple, reliable instrument for measuring the severity of patellar tendinopathy and is sensitive to small changes in symptoms. The VISA-P was specifically designed for patellar tendinopathy, rating pain, symptoms, simple test of function and the ability to play sports. Six of the eight questions are scored on a VAS from 0 to 10 points, with 10 representing optimal health. The maximum VISA-P score for an asymptomatic athlete is 100 points. - Pain on a Visual Analogue Scale (VAS) in which 0 represents no pain, and 100 maximal pain: during rest during activities of daily living (ADL), during sports after sports during a functional test: the single leg decline squat (SLDS); the athlete performs one time a single leg squat to 60° of knee flexion on a 25° decline board. This test was designed to preferentially load the patellar tendon. during a functional test: the single leg decline squat (SLDS); the athlete performs ten times a single leg squat to 60° of knee flexion on a 25° decline board. This test was designed to preferentially load the patellar tendon. - Perceived improvement, with use of a 4-grade scale as *no symptoms*, improved, but still symptomatic*, *no change*, *worse*. (for PT subjects only) - Sport participation, sport level and sport activity throughout the study - Participant characteristics: Age, gender, length, weight

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)