M19 M17
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 200 patients with osteoarthritis, 50 healthy adults
Exclusion criteria
Exclusion criteria: Patients with changes in any medications affecting autonomic regulation (e.g. antihypertensive drugs); patients with diabetes, cardiac arrhythmias, ischemic heart disease or chronic heart failure; patients with hallux rigidus, valgus deformity of the midfoot, other symptomatic deformity of the foot, advanced arthropathy of the hindfoot, previous joint arthrodesis, tibial osteotomy within the previous 5 years, knee joint lavage within the previous 3 months, intra-articular corticosteroid injection within the previous month, and changes in drug treatment for osteoarthritis within the previous week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In patients with osteoarthritis, we will examine whether there are changes before, 1 month and 3 months after orthopaedic treatment (I) in sympathetic and parasympathetic cardiovascular activity and baroreflex sensitivity at rest and during standardized autonomic challenge maneuvers (active standing, Valsalva maneuver and metronomic deep breathing) (II) in pain intensity (visual analogue scales, „Western Ontario and McMaster Universities Osteoarthritis index“), course of pain (“German pain questionnaire“, „knee society knee score“), quality of pain, quality of life as well as stress level (“German pain questionnaire“, Likert scales) (III) in the level of depression (“Beck’s Depression Inventory”) | — |
Secondary
| Measure | Time frame |
|---|---|
| For this study no secondary endpoints were defined. | — |
Countries
Germany
Contacts
Neurologische Universitätsklinik Erlangen