Effect of open-label placebos on health status in patients with painful knee joint arthrosis - a randomized controlled trial
- Conditions
- chronic knee pain in knee joint arthrosis (Kellgren II - III)
- Registration Number
- DRKS00015191
- Lead Sponsor
- Institut für Medizinische Psychologie, LMU München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Minimum age 18 years; clinically confirmed knee joint arthrosis based on radiological criteria (Kellgren-Lawrence Grade II- III) for at least 6 months prior to screening; current pain score (NRS 0-10) at one knee joint >= 4; current pain score (NRS 0-10) at the contralateral knee joint <= 3; subjects with good nutritional status/general condition; subjects are able to speak and write the German language; subjects are able to give written informed consent to participate in the study; subjects are willing and able to comply with the study requirements and instructions (patient compliance is guaranteed).
Major injury or surgery to the study joint in the three months prior to study entry; pain that could influence knee pain assessment (e.g., pain in other parts of the lower extremities); other inflammatory joint disease, acute gout attack; known depression or HADS-D score >10 on the 'Hospital Anxiety and Depression Scale' depression scale; known intolerance or allergy to lactose or gelatin; gastrointestinal ulcers; epilepsy; Clinically significant cardiovascular, hepatic, renal, respiratory, hematologic, inflammatory, neurologic, endocrinologic, metabolic, or other medical or psychological conditions that, in the opinion of the study director and investigator, may preclude participation; Substance abuse or alcoholism; planned surgery during the study period; pregnancy or lactation; participation in another study within the past 4 weeks; intra-articularly injected knee pain medications; opioid analgesics, glucocorticoids, topical pain treatment; systemic treatments that could affect outcomes during the study; medications that affect the autonomic nervous system or neuroendocrine system; use of psychotropic drugs.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Group differences in the reduction of knee joint pain (NRS pain, WOMAC) after 3 weeks. <br>2) Group differences in improvement of knee joint range of motion (neutral-zero method) after 3 weeks.
- Secondary Outcome Measures
Name Time Method 1) Course of pain and mood (NRS) and need for concomitant medication over the study period (study diary).<br><br>2) Improvement in mood (NRS), quality of life (SF-36) and general health status (CGI) after 3 weeks.<br><br>3) Stress reduction (PSQ score, cortisol variability over the day, heart rate variability) after 3 weeks.