Jongen, BSc, Karlijn (2020) The effectiveness of eccentric calf muscle exercise therapy in patients with chronic midportion Achilles tendinopathy: a pilot study determining the required sample size for an adequate analysis. thesis, Medicine.
Full text available on request.Abstract
Background: Chronic midportion Achilles tendinopathy (AT) limits patients in (sports) activities. The Dutch guideline recommends eccentric calf muscle exercise therapy. It is doubtful whether this, often painful, exercise therapy is superior to other forms of exercise therapy. This study determined the sample size needed to demonstrate a statistically significant and clinically relevant difference in the treatment effect of eccentric calf muscle exercise therapy. Method: This was a prospective, randomized controlled pilot study. Sixteen patients (18-70 years), with chronic midportion AT were randomly assigned into two groups: (i) eccentric calf muscle exercise therapy (intervention, n = 8) or (ii) strength training of the upper extremities (control, n = 8). Both groups received advices for load management. The required sample size, the feasibility of the main study and the effectiveness of treatment were determined and evaluated. Results: The required sample size ranges from 14 to 81 patients. Taking into account the observed dropout rate of the study (25%), 67 patients have to be included in the main study. The recruitment percentage was 65.8% of eligible patients, with an inclusion rate of 8 patients per month. There was no significant change in VISA-A score within and between the groups after six weeks of therapy. Conclusion: The main study will be able to include the required 67 patients in 9 months. Considerations were given on how to maintain the current recruitment percentage and inclusion rate. The results of a pilot study should not be overstated and should not lead to relinquish the main trial. The effectiveness of the therapy will be further evaluated in the main trial.
| Item Type: | Thesis (UNSPECIFIED) |
|---|---|
| Supervisor name: | Dr. van Berkel, S. |
| Faculty: | Medical Sciences |
| Date Deposited: | 22 Nov 2023 12:40 |
| Last Modified: | 22 Nov 2023 12:40 |
| URI: | https://umcg.studenttheses.ub.rug.nl/id/eprint/3725 |
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