冷冻神经松解术治疗膝骨关节炎患者慢性疼痛的疗效：一项双盲随机对照假手术试验。
Cryoneurolysis for the management of chronic pain in patients with knee osteoarthritis; a double-blinded randomized controlled sham trial.
机构信息
Research Unit of Health Science, Hospital of South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark.
Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.
出版信息
BMC Musculoskelet Disord. 2021 Feb 26;22(1):228. doi: 10.1186/s12891-021-04102-1.
OBJECTIVE
Pain is the principal symptom in knee osteoarthritis (OA). Current non-operative treatment options have only moderate effects and often patients experience persistent pain or side-effects. Novel advances in the field of cryoneurolysis applies low temperatures to disrupt nerve signaling at the painful area, providing pain relief. The primary aim of this randomized controlled trial (RCT) is to investigate if cryoneurolysis is superior to sham at decreasing pain intensity 2 weeks after the intervention in patients with knee OA. Secondary aims are to explore effects on pain, quality of life and functional performance over 24 months.
METHODS
This two-arm, parallel-group RCT, approved by the Regional Ethics Committee, will randomly allocate patients (n = 94) to a cryoneurolysis intervention group + standardized education and exercise (CRYO) or a sham group + standardized education and exercise (SHAM) (1:1 ratio). Both groups will be assessed at baseline, 2 weeks post intervention, post education and exercise and at 6, 12 and 24 months after cryoneurolysis. The primary outcome is the NRS knee pain intensity score assessed 2 weeks post the intervention. Secondary outcome measures include functional performance (chair-stand test, 40 m walk, stair test and maximum voluntary contraction of the knee), patient reported outcomes (quality of life (EQ5D), Knee and osteoarthritis outcome scores (KOOS), among others), use of analgesics, and adverse events over 24 months.
IMPACT STATEMENT
Cryoneurolysis could potentially provide an effective, safe and non-pharmacological therapeutic option to treat pain in OA patients. The potential benefits include increased functional capacity and quality of life as a result of significant pain relief and improved benefits of physical exercise.
TRIAL REGISTRATION
Clinicaltrials.gov, NCT03774121 , registered 3 March 2018, http://www.clinicaltrials.gov.
目的
疼痛是膝骨关节炎（OA）的主要症状。目前的非手术治疗选择仅有中等疗效，且患者常经历持续性疼痛或副作用。冷冻神经松解术领域的新进展应用低温来破坏疼痛区域的神经信号，从而缓解疼痛。本随机对照试验（RCT）的主要目的是研究冷冻神经松解术是否优于假手术，以在干预后 2 周降低膝骨关节炎患者的疼痛强度。次要目的是探索 24 个月内对疼痛、生活质量和功能表现的影响。
方法
这项由地区伦理委员会批准的两臂、平行组 RCT 将随机分配患者（n=94）至冷冻神经松解术干预组+标准化教育和运动（CRYO）或假手术组+标准化教育和运动（SHAM）（1:1 比例）。两组均在基线时、干预后 2 周、教育和运动后以及冷冻神经松解后 6、12 和 24 个月进行评估。主要结局是干预后 2 周时的 NRS 膝关节疼痛强度评分。次要结局包括功能表现（坐站测试、40m 步行、楼梯测试和膝关节最大自主收缩）、患者报告的结局（生活质量（EQ5D）、膝关节和骨关节炎结局评分（KOOS）等）、镇痛药的使用以及 24 个月内的不良事件。
意义
冷冻神经松解术可能为 OA 患者的疼痛提供一种有效、安全且非药物治疗的选择。潜在的益处包括由于疼痛显著缓解和改善身体运动的益处而导致的功能能力和生活质量提高。
试验注册
Clinicaltrials.gov，NCT03774121，注册于 2018 年 3 月 3 日，http://www.clinicaltrials.gov。
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