chronic knee pain in knee joint arthrosis (Kellgren II - III)
Conditions
Interventions
Group 1: Open-label placebo with verbal suggestion of "pain improvement"
Group 2: Open-label placebo with verbal suggestion of "mood improvement"
Group 3: No treatment control group
Sponsors
Institut für Medizinische Psychologie, LMU München
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Group differences in the reduction of knee joint pain (NRS pain, WOMAC) after 3 weeks. 2) Group differences in improvement of knee joint range of motion (neutral-zero method) after 3 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Course of pain and mood (NRS) and need for concomitant medication over the study period (study diary). 2) Improvement in mood (NRS), quality of life (SF-36) and general health status (CGI) after 3 weeks. 3) Stress reduction (PSQ score, cortisol variability over the day, heart rate variability) after 3 weeks. | — |
Countries
Germany
Contacts
Public ContactKarin Meißner
Institut für Medizinische Psychologie, LMU München
Outcome results
None listed