Clinical trial NCT05702918: Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy
Official title: Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy Using Ultrasonography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Achilles Tendinopathy
Keywords: Achilles Tendinopathy
Extracorporeal Shockwave Therapy
Ultrasonography
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be divided into two groups. Group A will follow resistance training protocol and receive ESWT. Group B will follow resistance training only.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Peak Spatial Frequency Radius at the site of Pathology
timeFrame: Change of initial values at 39 weeks follow up after beginning of the therapy.
measure: Change in VISA-A Questionnaire Score
timeFrame: Change of initial values at 39 weeks follow up after beginning of the therapy.
Secondary outcomes:
measure: Change in Tendon Diameter at the Place of Maximum Tendon Width
timeFrame: Change of initial values at 39 weeks follow up after beginning of the therapy.
measure: Change in Maximum Pain in the Achilles Tendon Area
timeFrame: Change of initial values at 39 weeks follow up after beginning of the therapy.
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: University Hospital Motol and 2nd Faculty of Medicine, Charles University
Study officials:
affiliation: University Hospital Motol and 2nd Faculty of Medicine, Charles University
name: Stanislav Machač, PhD
role: STUDY_CHAIR
References: