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

Achilles Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05702918
• Other study ID #: EK-402 /22
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2023
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Tendinopathy

Intervention

Device:
• BTL-6000 FSWT
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).

Other:
• 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.

Locations

Country	Name	City	State
Czechia	University Hospital Motol and 2nd Faculty of Medicine, Charles University	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Spatial Frequency Radius at the site of Pathology	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.	Change of initial values at 39 weeks follow up after beginning of the therapy.
Primary	Change in VISA-A Questionnaire Score	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 of initial values at 39 weeks follow up after beginning of the therapy.
Secondary	Change in Tendon Diameter at the Place of Maximum Tendon Width	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.	Change of initial values at 39 weeks follow up after beginning of the therapy.
Secondary	Change in Maximum Pain in the Achilles Tendon Area	Measured by numeric rating scale in points. The values can reach 0-10 points. A higher score means worse pain.	Change of initial values at 39 weeks follow up after beginning of the therapy.