Comparative Analysis of the Effectiveness of the Use of Nimesulide and CBD Oil in Patients With Pain in the Preauricular Region Due to the Pain-dysfunctional Syndrome of the Temporomandibular Joint.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Psychological conditions
研究概览
简要总结
During the study, the effectiveness of analgesic therapy with nimmsulide and cannabidiol oil will be compared.
Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Clinic of PUM in Szczecin. Patients aged 18-65 years with pain located in the area of the temporomandibular joint and the preauricular area, resulting from a dysfunction of the temporomandibular joint, will be included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (female and male) aged 18-65 years, able to swallow tablets
- •Patients with pain located in the temporomandibular and preauricular regions resulting from temporomandibular joint dysfunction
- •Patients with clinical diagnosis of Temporomandibular Joint Dysfunction
排除标准
- •patients with clinically diagnosed acute inflammation of the outer ear, middle ear, sinuses of the nose
- •patients allergic to nimesulide or cannabidiol oil
- •patients with contraindications to include therapy with nimesulide or cannabidiol oil such as:
- •gastric or duodenal ulcer disease,
- •severe blood clotting disorders,
- •severe liver dysfunction,
- •severe renal impairment,
- •severe heart failure, pregnancy,
- •breastfeeding,
- •concomitant intake of citrochrome blockers CYP3A4 or CYPP2D6 (warfarin, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil, SSRI, tricyclic antidepressants, opioids)
研究组 & 干预措施
The group that received nimesulide
干预措施: Nimesulide (Drug)
The group that received CBD Oil
干预措施: Cannabidiol Oil (Drug)
结局指标
主要结局
Psychological conditions
时间窗: 15 days
Measured on The General Health Questionnaire-28 (GHQ-28)
Pain relief
时间窗: 15 days
Measured on Visual Analogue Scale (VAS) scale. It consists of a line, approximately 100mm in length, at the left end of the scale "Score 0" which means "no pain", at the right end of the scale "Score 100mm" which means "worst imaginable pain"
次要结局
未报告次要终点
研究者
Dalewski Bartosz
Principal Investigator
Pomeranian Medical University Szczecin