Effect of open-label placebos on health status in patients with painful knee joint arthrosis - a randomized controlled trial

Institut für Medizinische Psychologie, LMU München0 个研究点目标入组 60 人开始时间: 2021年10月29日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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.

发起方

Institut für Medizinische Psychologie, LMU München