Comparison of Topical 1% Diclofenac and Topical 2.5% Hydrocortisone for TMJ Arthralgia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in pain intensity
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of topical 2.5% hydrocortisone in TMJ arthralgia. The main questions it aims to answer are:
- How does pain reduction compare?
- How does improvement in jaw function limitation compare?
- How do side effects compare? Participants will
- On day 1 be examined and report their pain level and jaw function limitation
- On days 1-21, apply their cream four times a day
- On day 21, report their pain level, jaw function limitation, compliance with instructions, and side effects.
Researchers will compare topical 2.5% hydrocortisone and topical 1% diclofenac to see if efficacy and side effects differ.
详细描述
- Person 2 will label creams, patient packets (pre-stamped envelope, questionnaire, consent form), and give packets to Person 1 in the order in which they are to be dispensed.
- Person 1 will recruit all eligible patients in the order in which they are seen, enrolling all that consent. Packets and gel will be given to patient, and written and verbal instructions, including that email will be sent saying "Keep it up!" to remind them to continue applying get, as well as "Please send us your questionnaire". Consent forms will be stored in locked drawer.
- Person 1 will remind patient on days 7 and 14 to continue with the study
- Person 1 will remind patient on day 21 to mail back the completed questionnaire
- Person 1 will reach out to all patients from whom the questionnaire is not returned within 1 week of day 21, and do so at weekly intervals a minimum of 3 times.
- Person 1 will enter data in Excel as it comes, reaching out to patients if there are questions. Excel file uses random number ID, not patient name, thereby anonymizing the data
- Persons 1, 2, 3, and 4 will decide which patient's data, if any, should be removed
- Person 1 will send complete anonymized Excel data file (containing all patients) to Person 3
- Person 2 will determine, using random number generator, which group will be referred to as "Group A" during the statistical analysis, and which will be referred to as "Group B"
- Person 2 will tell Dr. Korczeniewska which data will be in Group A, and which will be in Group B
- Person 3 will perform statistical analysis
- Person 2 will reveal which group was Hydrocortisone, and which was Diclofenac
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Cream containers labeled by randomly-generated numbers, by person not involved in analysis or patient interaction.
Statistical analysis done by person not aware of the treatment received by each group
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
- •Arthralgia of at least 1 TMJ for at least 3 days
排除标准
- •Systemic pain condition
- •Past adverse reaction to steroid
- •Currently taking steroid
- •Taken steroid in the past ___ months
- •Muscle relaxants (may start after study is complete)
- •New night guard during study, or within 1 month of start of study (may start after study is complete)
研究组 & 干预措施
Hydrocortisone topical
2.5% hydrocortisone cream
干预措施: Hydrocortisone 2.5% (Drug)
Diclofenac topical
1% diclofenac cream
干预措施: Diclofenac 1% topical (Drug)
结局指标
主要结局
Change in pain intensity
时间窗: Pain measured on days 1 and 21
Using Visual Analog Scale, Range 0 - 10 cm, with 0 cm = no pain, and 10 cm = extreme pain
Change in jaw function limitation
时间窗: Jaw function limitation measured on days 1 and 21
Using jaw function limitation scale, Range 0-10 for each of the 8 parameters, with 0 = no limitation, and 10 = severe limitation
次要结局
- Number of participants with side effects(Reported on day 21)
研究者
Andrew Young
Assistant Professor, Department of Diagnostic Sciences
University of the Pacific