N/A
N=18
Ultrasound-Monitored Changes in Achilles Tendinopathy After Extracorporeal Shock Wave Therapy
Achilles Tendinopathy
Bottom Line
View on ClinicalTrials.gov: NCT04780919 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Change in Cross-sectional Area at the Place of Maximum Tendon Width — 0.8; 0.76; 0.78; 0.69 cm^2 — p=0.722
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BTL-6000 FSWT (Device); BTL-6000 FSWT with sham applicator (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University Hospital, Motol
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cross-sectional Area at the Place of Maximum Tendon Width |
0.8; 0.76; 0.78; 0.69 | 0.722 |
| PRIMARY Change in Maximum Pain in the Achilles Tendon Area |
6.6; 6.1; 3.6; 5.2 | 0.096 |
| PRIMARY Change in Maximum Pain in the Achilles Tendon Area (Follow up) |
6.6; 6.1; 2.7; 5 | 0.035 sig |
| PRIMARY Change of Ankle Dorsiflexion Range of Motion |
7.4; 8.7; 10.1; 8.7 | 0.171 |
| SECONDARY Number of Participants With Hypoechogenic Areas |
6; 6; 6; 6 | — |
| SECONDARY Number of Participants With Increased Thickness of Achilles Tendon |
5; 4; 5; 4 | — |
| SECONDARY Change in VISA-A Questionnaire Score |
64.3; 65.3; 84.9; 69.2 | 0.104 |
| SECONDARY Change in Single Leg Heel Rise Test |
16.6; 21.8; 26.4; 26.5 | — |
| SECONDARY Change in Single Leg Hop Test |
31.1; 29.5; 51.9; 45.0 | — |
Summary
This study is designed as a randomized, placebo-controlled clinical trial in which we monitor the effects of low-energy focused extracorporeal shockwave therapy (ESWT) in patients with Achilles tendinopathy (AT). Participants will be randomly divided into two groups. ESWT according to selected parameters will be applied to Group A. Group B will receive sham ESWT.
Patients in both groups will have the same program. The research for one patient lasts a total of 8 weeks (2 months) from the initial to the final examination. In the first week, there will be a clinical examination by a physiotherapist, an ultrasonographic examination, and the patient will complete a VISA-A questionnaire. At the end of the examination, the patient will be randomly assigned to group A or B and receive the first application. For the next 4 weeks, additional applications will be performed once a week. The interval between individual applications should be at least 7 days. Thus, a total of 5 applications of ESWT or sham ESWT will be performed. The final examination will take place 3 weeks after the last application and will include the same procedures as for the initial examination.
Eligibility Criteria
Inclusion Criteria
- the patient complains about Achilles tendon pain, which limits (at least partially) his quality of life during daily activities or sport, and this condition would be referred as a tendinopathy
- the patient's other leg is asymptomatic
- the patient is not aware of the symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
- the patient has no previous experience with extracorporeal shockwave therapy treatment
Exclusion Criteria
- the patient has condition which is contraindication for extracorporeal shock wave therapy treatment
- the patient had symptomatical mechanical tendon damage in past (eg. partial or complete rupture due to injury)
Data sourced from ClinicalTrials.gov (NCT04780919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.