70 Chapter 4 Netherlands). This cross-sectional study was part of a clinical trial, in which this part was completed before any intervention was given. The local Medical Ethics Committee (Southwest-Holland, the Netherlands) approved the study protocol (MEC 14-100). The trial was registered before commencement (ClinicalTrials.gov; NCT02996409). Patient and Public involvement Patients or public were not involved in the design and conduct of the study, the choice of outcome measures or the development of the research questions. Patients The study was conducted at the sports medicine department of a large regional hospital (Haaglanden Medical Centre), from December 2016 to January 2019. A study announcement was made through informing healthcare professionals (both medical and paramedical) and patients via letters, conferences and social media platforms. If patients passed a telephone and online screening, an appointment with the sports medicine physician was planned to assess eligibility. The main inclusion criteria were: (1) age 18-70 years, (2) painful swelling of the midportion of the Achilles tendon (2-7 cm proximal of the calcaneal insertion) (3) symptom duration of more than two months and (4) no response to at least six weeks of exercise therapy. The main exclusion criteria were: an Achilles tendon rupture, clinical suspicion of other tendinopathies (including insertional AT), inability to perform exercise therapy and previous surgical intervention for this condition. The full list of inclusion and exclusion criteria is displayed on ClinicalTrials.gov. Written informed consent was obtained from all subjects before inclusion. Procedures We obtained the outcome measures of this cross-sectional study before any intervention was given. Patients filled in several questionnaires directly following the inclusion appointment with the sports medicine physician. For the clinical trial, patients received either a peritendinous high-volume injection or a placebo injection. The results of this clinical trial have been published elsewhere.19 Outcome measures Primary outcome measure Quality of life was measured using the validated Dutch version of the EuroQol questionnaire (EQ-5D-3L). 20 The EQ-5D-3L consists of five questions involving the following dimensions: mobility, self-care, daily activities, pain, and anxiety/mood. Each domain consists of three response options: no problems, moderate problems and major problems. The results of the EQ-5D are dichotomized and expressed as the percentage of subjects with moderate or major problems (any problem) 21. The EuroQol Visual Analogue Scale (EQ-VAS) was used
RkJQdWJsaXNoZXIy MTk4NDMw