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

NCT ID: NCT05702918

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2024-12-01

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.

Detailed Description

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.

Conditions

Achilles Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A - ESWT + exercise

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.

Group Type: ACTIVE_COMPARATOR

BTL-6000 FSWT

Intervention Type: 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).

Achilles Tendon Loading Exercise Protocol According to Silbernagel

Intervention Type: 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 B - exercise

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.

Group Type: ACTIVE_COMPARATOR

Achilles Tendon Loading Exercise Protocol According to Silbernagel

Intervention Type: 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.

Interventions

BTL-6000 FSWT

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).

Intervention Type: DEVICE

Achilles Tendon Loading Exercise Protocol According to Silbernagel

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Motol

OTHER

Sponsor Role: lead

Responsible Party

Stanislav Machač, Ph.D

Academic worker

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stanislav Machač, PhD

Role: STUDY_CHAIR

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

Locations

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

Prague, , Czechia

Countries

Czechia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EK-402 /22

Identifier Type: -

Identifier Source: org_study_id