Degen Bojana, Szczesna Anna, Nickel Christian H, Bingisser Roland, Gaab Jens, Minotti Bruno
Divison of Clinical Psychology and Psychotherapy, Faculty of Psychology, University of Basel, Basel, Switzerland
Emergency Department, University Hospital Basel, Basel, Switzerland.
BMJ Open. 2025 Mar 25;15(3):e090508. doi: 10.1136/bmjopen-2024-090508.
Non-specific pain (NSP), defined as pain without a clear pathological cause, is a common presentation in the emergency department (ED). There is no universally accepted analgesic strategy, but non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are often prescribed. However, the established efficacy of NSAIDs for NSP is limited. Additionally, NSAIDs are associated with an increased risk of upper gastrointestinal bleeding, acute kidney injury and cardiovascular events, such as myocardial infarction and stroke. There is increasing evidence supporting the analgesic effects of open-label placebo (OLP), defined as placebo administered to patients without deception, in a broad variety of settings. Accordingly, OLP could be a safer, effective analgesic treatment option for NSP. To our knowledge, this is the first study investigating the feasibility of OLP for NSP in the ED. Therefore, our primary objective is to assess whether OLP is a feasible treatment option in this setting.
Patients diagnosed with acute NSP will be prospectively recruited at discharge in the ED at the University Hospital of Basel, Switzerland. Patients treated with pain medication for >7 days prior to ED visit or with chronic pain will be excluded. Patients will be randomised to receive either OLP (intervention) or ibuprofen (control). Rescue medication will be ibuprofen in both groups. Daily online self-assessment will take place during the first 7 days after the baseline visit as well as on day 30. A qualitative interview will be conducted on day 30. The primary outcome is feasibility, consisting of acceptability, adherence to the protocol and patient satisfaction. Clinical outcomes will focus on pain intensity and interference according to the Brief Pain Inventory Short Form as well as adverse events.
The study protocol has received approval from the ethics committee for Northwestern and central Switzerland (EKNZ; project ID 2024-00089). The results will be disseminated in peer-reviewed journals and at scientific conferences.
Swiss National Clinical Trials Portal (SNCTP000005852); Clinicaltrial.gov (NCT06408519).
非特异性疼痛（NSP）被定义为无明确病理原因的疼痛，是急诊科（ED）常见的症状表现。目前尚无普遍接受的镇痛策略，但布洛芬等非甾体抗炎药（NSAIDs）常被开具处方。然而，NSAIDs对NSP的确立疗效有限。此外，NSAIDs与上消化道出血、急性肾损伤以及心血管事件（如心肌梗死和中风）风险增加相关。越来越多的证据支持开放标签安慰剂（OLP，即无欺骗地给予患者的安慰剂）在多种情况下的镇痛作用。因此，OLP可能是一种用于NSP的更安全、有效的镇痛治疗选择。据我们所知，这是第一项研究OLP用于急诊科NSP可行性的研究。因此，我们的主要目标是评估OLP在此情况下是否为可行的治疗选择。
在瑞士巴塞尔大学医院急诊科出院时前瞻性招募被诊断为急性NSP的患者。急诊就诊前接受止痛药物治疗超过7天或患有慢性疼痛的患者将被排除。患者将被随机分为接受OLP（干预组）或布洛芬（对照组）。两组的急救药物均为布洛芬。在基线访视后的前7天以及第30天进行每日在线自我评估。在第30天进行定性访谈。主要结局是可行性，包括可接受性、对方案的依从性和患者满意度。临床结局将聚焦于根据简明疼痛量表简表评估的疼痛强度和干扰情况以及不良事件。
该研究方案已获得瑞士西北部和中部伦理委员会（EKNZ；项目编号2024 - 00089）的批准。研究结果将在同行评审期刊和科学会议上发表。
瑞士国家临床试验门户网站（SNCTP000005852）；Clinicaltrial.gov（NCT06408519）。
