PhaseIV Study of Intra-articular Methylprednisolone in TMJ Arthralgia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 7
- 主要终点
- VAS pain score change at maximal mouth opening
研究概览
简要总结
The hypothesis is that a single dose intra-articular injection of corticosteroids are effective in relieving temporomandibular arthralgia pain.
The purpose of the study is therefore to evaluate the effect of a single dose intra-articular methylprednisolone vs. placebo in a month perspective on subjects with unilateral arthralgia of the TMJ.
详细描述
This is a randomized blinded multicenter controlled study on 64 subjects (18 years or older) with the diagnosis of unilateral arthralgia of the TMJ.
The subject visit the clinic at three occasions; one enrollment visit, one baseline treatment visit and one evaluation visit one month after baseline.
One week after baseline a follow-up telephone call is made with the purpose to track adverse events.
Pain questionaries are completed morning, lunch and dinnertime during three days before treatment, five days after treatment and three days proceeding the evaluation visit.
The study ís planned to commence 10th December 2013 and last patient out 15th January 2015.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or above
- •the diagnosis arthralgia in one TMJ
- •understands Swedish both verbally and in written
- •signed informed concent
排除标准
- •TMJ sounds in terms of clicking (crepitation allowed))
- •polyarthritis/connective tissue disease
- •bilateral TMJ arthralgia
- •fibromyalgia or other generalized pain
- •ongoing infection
- •ongoing dental treatment
- •intra-articular corticosteroid injection of a TMJ the past 6 months
- •previous surgery of the affected TMJ
- •complex psychiatric/psychologic status
- •institutionalized living including prisoners
- •staff at the investigational clinic
- •hypersensitive to local anesthetics
- •hypersensitive to methylprednisolone
- •hemophilia
- •methemoglobinemia
- •compromized health status according to the judgment of the investigator
- •concommitant use of the drugs cyclosporine, erythromycin, pentobarbital, itraconazole, ketoconazole, Rifampicin, Acetylsalicylic acid, Oral anticoagulant
- •mentally retarded
研究组 & 干预措施
Physiologic saline
Sodium chloride 9 mg/ml liquid for parental use
干预措施: Methylprednisolone (Drug)
Methylprednisolone
Depo-Medrol 40 mg/ml, single dose, injection, intra-articular
干预措施: Physiologic saline (Drug)
结局指标
主要结局
VAS pain score change at maximal mouth opening
时间窗: 4 weeks
100 mm analog Visual Analog Scale with endpoints "No pain" and "Worst pain imaginable" The intra-individual change of the VAS pain score between baseline and end of study
次要结局
- Adverse events(4 weeks)
- VAS pain score change at jaw rest(4 weeks)
- Instrument measures(4 weeks)