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

Not Applicable

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

• Registration Number: NCT05702918
• Lead Sponsor: University Hospital, Motol

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 39 weeks from the initial to the final examination and will include several control measurements: at 6, 12, 26 and 39 weeks 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 Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-01
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - ESWT + exercise	BTL-6000 FSWT	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 0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 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 A - ESWT + exercise	Achilles Tendon Loading Exercise Protocol According to Silbernagel	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 0.14 mJ/mm2, frequency 6 Hz, total number of shocks 1800. The application will be semi-static at the location of the largest USG finding. 600 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 B - exercise	Achilles Tendon Loading Exercise Protocol According to Silbernagel	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.

Primary Outcome Measures

Name	Time	Method
Change in VISA-A Questionnaire Score	Change of initial values at 39 weeks follow up after beginning of the therapy.	The VISA-A questionnaire is standardized questionnaire for patients with Achilles tendinopathy. The results are recorded in points (0-100 points). The higher score indicates patients better condition.
Change in Peak Spatial Frequency Radius at the site of Pathology	Change of initial values at 39 weeks follow up after beginning of the therapy.	Measured by spatial frequency analysis software from ultrasound picture in mm-1. In a linear view with specific settings of ultrasound machine, the site of the largest pathology is selected, then the image is saved and uploaded to the software that evaluates the PSFR parameter.

Secondary Outcome Measures

Name	Time	Method
Change in Maximum Pain in the Achilles Tendon Area	Change of initial values at 39 weeks follow up after beginning of the therapy.	Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.
Change in Tendon Diameter at the Place of Maximum Tendon Width	Change of initial values at 39 weeks follow up after beginning of the therapy.	Measured by measuring tools in ultrasound machine in mm2. In linear view is selected maximal width place, then the tendon diameter is measured using device tools.

Trial Locations

Locations (1)

University Hospital Motol and 2nd Faculty of Medicine, Charles University; 🇨🇿 Prague, Czechia