N/A
N=47
Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy
Achilles Tendinopathy
Bottom Line
View on ClinicalTrials.gov: NCT05702918 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Peak Spatial Frequency Radius at the Site of Pathology — 2.180; 2.146; 2.194; 2.184 mm^-1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BTL-6000 FSWT (Device); Achilles Tendon Loading Exercise Protocol According to Silbernagel (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Motol
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Spatial Frequency Radius at the Site of Pathology |
2.180; 2.146; 2.194; 2.184 | — |
| PRIMARY VISA-A Questionnaire Score |
66.9; 62.9; 92.7; 86 | — |
| SECONDARY Tendon Diameter at the Place of Maximum Tendon Width |
6.0; 6.6; 5.9; 6.4 | — |
| SECONDARY Pain Intensity Measured by Numeric Rating Scale (NRS) |
6.8; 5.7; 1.8; 1.9 | — |
Summary
This work is designed as a randomized clinical trial, in which the effects of a protocol of 12-week resistance training loading the Achilles tendon and low-energy focused extracorporeal shock wave therapy (ESWT) in patients with Achilles tendinopathy (AT) will be monitored. It is estimated that at least 40 patients will participate, randomly divided into two groups. Group A will be instructed to perform a training protocol in combination with ESWT according to selected parameters. Group B only completes the same training protocol.
Eligibility Criteria
Inclusion Criteria
- the patient shows symptoms of Achilles tendinopathy (pain, swelling and dysfunction in the area of Achilles tendon), which at least partially limit his quality of life during normal or sporting activities,
- the patient is in the age group of 18-60 years,
- the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference,
- the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury),
- the patient has not undergone any treatment aimed at AS in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective US examination of AS shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.).
Exclusion Criteria
- patient has been diagnosed with a rheumatic disease or a disease of the central nervous system
- patient has any condition which is contraindication for ESWT application
- patient is aware of mechanical damage to the Achilles tendon as a result of an injury in the past.
Data sourced from ClinicalTrials.gov (NCT05702918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.