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

NCT05702918 | Completed Results

• 1 other identifier: EK-402 /22
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Achilles Tendinopathy

Keywords

Achilles Tendinopathy; Extracorporeal Shockwave Therapy; Ultrasonography

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Values at baseline and week 26.

Secondary Outcomes (2)

• Tendon Diameter at the Place of Maximum Tendon Width

  Values at baseline and week 26.

• Pain Intensity Measured by Numeric Rating Scale (NRS)

  Values at baseline and week 26

Study Arms (2)

Group A - ESWT + exercise

ACTIVE COMPARATOR

Participants in group A will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day. In addition, participants will receive a low-energy focused ESWT. In total, it will be applied 4 times with an interval of 7 days from the BTL-6000 FSWT device with piezoelectric generator. 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). The set values will not change throughout the research. These parameters were selected in accordance to ISMST guidelines.

Device: BTL-6000 FSWT; Other: Achilles Tendon Loading Exercise Protocol According to Silbernagel

Group B - exercise

ACTIVE COMPARATOR

Participants in group B will complete a 12-week ankle dorsiflexion resistance training protocol according to Silbernagel. It is a series of heel rise exercises with a gradual progression of load according to defined criteria, which the patient practices every day.

Other: Achilles Tendon Loading Exercise Protocol According to Silbernagel

Interventions

BTL-6000 FSWT DEVICE

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).

Group A - ESWT + exercise

Achilles Tendon Loading Exercise Protocol According to Silbernagel OTHER

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.

Group A - ESWT + exercise; Group B - exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

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

Prague, Czechia

Location

Results Point of Contact

• Title: Mgr. Jakub Katolický
• Organization: Second Faculty of Medicine, Charles University

jakubkatolicky@gmail.com

+420702088258

Study Officials

• Stanislav Machač, PhD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic worker

Model Details: Participants will be divided into two groups. Group A will follow resistance training protocol and receive ESWT. Group B will follow resistance training only.

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: January 24, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2023-12

Locations

CZ (1)