Achilles Tendinopathy
Conditions
Keywords
Achilles Tendinopathy, Extracorporeal Shockwave Therapy, Ultrasonography
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.
Interventions
DEVICEBTL-6000 FSWT
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).
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.
Sponsors
University Hospital, Motol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Spatial Frequency Radius at the Site of Pathology | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Tendon Diameter at the Place of Maximum Tendon Width | Values at baseline and week 26. | Achilles tendon diameter was measured using standardized B-mode ultrasound imaging at the site of maximal tendon width. Measurements were performed using built-in ultrasound system measurement tools. Measurements were recorded at baseline and at the 26-week follow-up. |
| Pain Intensity Measured by Numeric Rating Scale (NRS) | Values at baseline and week 26 | Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores were recorded at baseline and at the 26-week follow-up. |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A - ESWT + Exercise 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 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. | 21 |
| Group B - Exercise 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. | 20 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Unrelated injury | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Group A - ESWT + Exercise | Group B - Exercise | Total |
|---|---|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 11.7 | 32.8 years STANDARD_DEVIATION 11.8 | 33.1 years STANDARD_DEVIATION 11.6 |
| Body Mass Index | 24.7 kg/m^2 STANDARD_DEVIATION 5.1 | 26.1 kg/m^2 STANDARD_DEVIATION 4.4 | 24.9 kg/m^2 STANDARD_DEVIATION 4.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 14 Participants | 11 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
Peak Spatial Frequency Radius at the Site of Pathology
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.
Time frame: Values at baseline and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - ESWT + Exercise | Peak Spatial Frequency Radius at the Site of Pathology | Baseline | 2.180 mm^-1 | Standard Deviation 0.093 |
| Group A - ESWT + Exercise | Peak Spatial Frequency Radius at the Site of Pathology | Week 26 | 2.194 mm^-1 | Standard Deviation 0.115 |
| Group B - Exercise | Peak Spatial Frequency Radius at the Site of Pathology | Baseline | 2.146 mm^-1 | Standard Deviation 0.067 |
| Group B - Exercise | Peak Spatial Frequency Radius at the Site of Pathology | Week 26 | 2.184 mm^-1 | Standard Deviation 0.094 |
Primary
VISA-A Questionnaire Score
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.
Time frame: Values at baseline and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - ESWT + Exercise | VISA-A Questionnaire Score | Baseline | 66.9 scores on scale | Standard Deviation 13.2 |
| Group A - ESWT + Exercise | VISA-A Questionnaire Score | Week 26 | 92.7 scores on scale | Standard Deviation 7.2 |
| Group B - Exercise | VISA-A Questionnaire Score | Baseline | 62.9 scores on scale | Standard Deviation 12.8 |
| Group B - Exercise | VISA-A Questionnaire Score | Week 26 | 86 scores on scale | Standard Deviation 11.5 |
Secondary
Pain Intensity Measured by Numeric Rating Scale (NRS)
Pain intensity was assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores were recorded at baseline and at the 26-week follow-up.
Time frame: Values at baseline and week 26
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - ESWT + Exercise | Pain Intensity Measured by Numeric Rating Scale (NRS) | Baseline | 6.8 scores on a scale | Standard Deviation 1.8 |
| Group A - ESWT + Exercise | Pain Intensity Measured by Numeric Rating Scale (NRS) | Week 26 | 1.8 scores on a scale | Standard Deviation 1.4 |
| Group B - Exercise | Pain Intensity Measured by Numeric Rating Scale (NRS) | Baseline | 5.7 scores on a scale | Standard Deviation 1.6 |
| Group B - Exercise | Pain Intensity Measured by Numeric Rating Scale (NRS) | Week 26 | 1.9 scores on a scale | Standard Deviation 1.8 |
Secondary
Tendon Diameter at the Place of Maximum Tendon Width
Achilles tendon diameter was measured using standardized B-mode ultrasound imaging at the site of maximal tendon width. Measurements were performed using built-in ultrasound system measurement tools. Measurements were recorded at baseline and at the 26-week follow-up.
Time frame: Values at baseline and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A - ESWT + Exercise | Tendon Diameter at the Place of Maximum Tendon Width | Baseline | 6.0 mm | Standard Deviation 2 |
| Group A - ESWT + Exercise | Tendon Diameter at the Place of Maximum Tendon Width | Week 26 | 5.9 mm | Standard Deviation 1.9 |
| Group B - Exercise | Tendon Diameter at the Place of Maximum Tendon Width | Baseline | 6.6 mm | Standard Deviation 2.2 |
| Group B - Exercise | Tendon Diameter at the Place of Maximum Tendon Width | Week 26 | 6.4 mm | Standard Deviation 1.8 |