Influence of non-surgical and surgical orthopedic treatment on stress and depression levels, sympathetic and parasympathetic cardiovascular modulation and baroreflex sensitivity in patients with osteoarthritis
Recruiting
- Conditions
- M19M17Other arthrosisGonarthrosis [arthrosis of knee]
- Registration Number
- DRKS00004602
- Lead Sponsor
- eurologische Universitätsklinik Erlangen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
200 patients with osteoarthritis, 50 healthy adults
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In patients with osteoarthritis, we will examine whether there are changes before, 1 month and 3 months after orthopaedic treatment<br>(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)<br>(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)<br>(III) in the level of depression (Beck’s Depression Inventory”)<br>
- Secondary Outcome Measures
Name Time Method For this study no secondary endpoints were defined.