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

University Hospital, Motol

Status: Completed

Conditions: Achilles Tendinopathy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05702918

EK-402 /22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Group A - ESWT + exercise

Active Comparator group

Description:

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.

Treatment:

Device: BTL-6000 FSWT

Other: Achilles Tendon Loading Exercise Protocol According to Silbernagel

Group B - exercise

Active Comparator group

Description:

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.

Treatment:

Other: Achilles Tendon Loading Exercise Protocol According to Silbernagel