Does Subacromial Injection With Glutamate Receptor (NMDAR) Antagonist, Ketamine, Attenuate Pain in Rotator Cuff Tendinopathy?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The hypothesis of the present study is that in patients with rotator cuff tendinopathy a specific pharmacological blocking of peripheral glutamate-receptor N-methyl-d-aspartate receptor type1 (NMDAR) glutamate receptors will result in pain alleviation. Activated NMDAR1 has been demonstrated to be crucial for pain regulation in various pain disorders, and in biopsies from patients with tendinopathy, NMDAR1 was found to be activated.
To test this hypothesis a specific NMDA receptor antagonist, ketalar (ketamine), will be injected guided by ultrasound into the subacromial space in patients with rotator cuff tendinopathy, and subsequently the pain response will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of rotator cuff tendinopathy by exercise-related shoulder pain with positive impingement tests as described by Hawkins and Neers, and MRI findings consistent with tendinopathy.
- •Symptom duration at least 1 year to ensure neuronal ingrowth and NMDAR expression
排除标准
- •previous surgery in any shoulder.
- •previous cortisone use, either as injections or orally
- •symptoms or signs of cervicobrachialgia or polyneuropathy
- •full thickness rotator cuff ruptures verified by MRI
- •primary inflammatory mediated pain, hence, patients with glenohumeral arthrosis, glenohumeral arthritis or systemic disorders predisposing for arthritis
- •a central component of pain perception manifested by radiating pain in the involved limb; implying worse outcome after subacromial decompression.
- •pregnancy
- •breastfeeding
- •reduced liver function (Increased serum bilirubin, ASAT or ALAT), decompensated heart failure (NYHA class 3-4)
- •increased intracranial pressure or disease of the central nervous system (CNS)
- •chronic alcoholism
- •psychiatric disease, increased intraocular pressure
- •acute intermittent porphyria
- •hyperthyroidism
- •use of thyroid hormones
- •upper respiratory tract infections
- •pneumonia
- •intracranial lesions
- •acute head injuries
- •ocular injuries
- •hydrocephalus
- •risk factors predisposing for intra-articular bleeding
- •increased risk of infection
研究组 & 干预措施
Ketalar
ketalar injection, subacromial
干预措施: Ketalar (Drug)
Ketalar
ketalar injection, subacromial
干预措施: NaCl 9% (Drug)
Placebo
physiological sodium chloride (NaCl 9%) injection, subacromial
干预措施: Ketalar (Drug)
Placebo
physiological sodium chloride (NaCl 9%) injection, subacromial
干预措施: NaCl 9% (Drug)
结局指标
主要结局
Pain
时间窗: 30 minutes
Comparison of pain assessed by a visual analogue scale both at rest and abduction, after selective N-methyl-d-aspartate receptor type 1 blocking by ketalar injection subacromially controlled against Ringer acetate injection.
次要结局
- Supraspinatus pressure pain threshold(30 minutes)
- Pressure pain tolerance(30 minutes)