Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy

University Hospital, Motol47 enrolled

Overview

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. The research within one patient will last a total of 26 weeks from the initial to the final examination and will include several control measurements: at 6, 12, and 26 week from the beginning of therapy. Potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. They will then be invited to an initial examination. This will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (USG) examination followed by a micromorphological analysis using special software. At the end of the initial examination, the participant will be randomly assigned to group A or B. The study program for a specific participant will depend on the assigned group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Achilles Tendinopathy

Interventions

BTL-6000 FSWTDEVICE

The energy will be set to 0.10-0.14 mJ/mm2, frequency 5 Hz, total number of shocks 2000. The application will be semi-static at the location of the largest USG finding. Shocks are applied from all three sides (medial, lateral, dorsal).

Achilles Tendon Loading Exercise Protocol According to SilbernagelOTHER

It is a 12-week Silbernagel ankle dorsiflexion resistance training protocol. It is a series of exercises with a gradual progression of load according to defined criteria, which the patient practices every day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital Motol and 2nd Faculty of Medicine, Charles University

Prague, Czechia

Outcomes

Primary Outcomes

Peak Spatial Frequency Radius at the Site of Pathology

Peak Spatial Frequency Radius (PSFR) was assessed using spatial frequency analysis (SFA) software applied to standardized B-mode ultrasound images of the Achilles tendon. Ultrasound images were acquired in a long-axis using predefined machine settings. The image was saved and exported for subsequent analysis. In the SFA software, the region corresponding to the site of maximal tendon pathology was selected, and PSFR values (mm-¹) were calculated. PSFR values were recorded at baseline and at the 26-week follow-up.

Time frame: Values at baseline and week 26.

VISA-A Questionnaire Score

The VISA-A questionnaire is a validated, disease-specific patient-reported outcome measure for Achilles tendinopathy. Scores range from 0 to 100 (score on scale), with higher scores indicating better function and fewer symptoms. Scores were recorded at baseline and at the 26-week follow-up.

Time frame: Values at baseline and week 26.

Secondary Outcomes

Tendon Diameter at the Place of Maximum Tendon Width

Achilles tendon diameter was measured using standardized B-mode ultrasound imaging at the site of maximal tendon width. Measurements were performed using built-in ultrasound system measurement tools. Measurements were recorded at baseline and at the 26-week follow-up.

Time frame: Values at baseline and week 26.

Pain Intensity Measured by Numeric Rating Scale (NRS)

Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores were recorded at baseline and at the 26-week follow-up.

Time frame: Values at baseline and week 26

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.