Evaluation of the Course and Effectiveness of Conservative Therapy in Patients With Achilles Tendinopathy Using Ultrasonography
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Achilles Tendinopathy
- Sponsor
- University Hospital, Motol
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Peak Spatial Frequency Radius at the Site of Pathology
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Stanislav Machač, Ph.D
Academic worker
Charles University, Czech Republic
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.
Outcomes
Primary Outcomes
Peak Spatial Frequency Radius at the Site of Pathology
Time Frame: Values at baseline and week 26.
Peak Spatial Frequency Radius (PSFR) was assessed using spatial frequency analysis (SFA) software applied to standardized B-mode ultrasound images of the Achilles tendon. Ultrasound images were acquired in a long-axis using predefined machine settings. The image was saved and exported for subsequent analysis. In the SFA software, the region corresponding to the site of maximal tendon pathology was selected, and PSFR values (mm-¹) were calculated. PSFR values were recorded at baseline and at the 26-week follow-up.
VISA-A Questionnaire Score
Time Frame: Values at baseline and week 26.
The VISA-A questionnaire is a validated, disease-specific patient-reported outcome measure for Achilles tendinopathy. Scores range from 0 to 100 (score on scale), with higher scores indicating better function and fewer symptoms. Scores were recorded at baseline and at the 26-week follow-up.
Secondary Outcomes
- Tendon Diameter at the Place of Maximum Tendon Width(Values at baseline and week 26.)
- Pain Intensity Measured by Numeric Rating Scale (NRS)(Values at baseline and week 26)