Symptomatic Management of Lyme Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys
研究概览
简要总结
Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and treatment courses. Excessive up-regulation of the inflammatory process has been shown in patients with antibiotic-refractory Lyme arthritis. The over-expressed pro-inflammatory cell mediators are downstream of NSAID inhibition, which would suggest initial inflammatory inhibition may be beneficial in these patients. While NSAIDs are known to reduce pro-inflammatory cell mediators early in the course of inflammation, research has shown that there are other cytokines that play a role in the healing after inflammation that are also inhibited by NSAIDs, and that NSAID use can delay healing.
It is not known if scheduled NSAID therapy will reduce, increase, or have no effect on the occurrence of refractory Lyme arthritis cases. The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis of Lyme arthritis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis, or at least decrease the duration of persistent Lyme arthritis symptoms.
The pilot study design randomizes patients to scheduled NSAIDs, scheduled acetaminophen, or scheduled NSAIDs x 1 week than acetaminophen. Primary outcomes are duration of arthritis symptoms, number of refractory cases, side effects and compliance.
详细描述
Specific Aims:
- Demonstrate feasibility to ensure adequate patient enrollment and symptomatic follow-up of patients with Lyme arthritis.
- Develop pilot data necessary for sample size and power calculations:
The purpose of the research study is to evaluate whether there is symptomatic benefit of schedule NSAID therapy in patients with Lyme arthritis diagnosis.
- Quantification of antibiotic-refractory Lyme arthritis in our population
- Symptomatic outcomes of patients with Lyme arthritis on scheduled NSAIDs versus those not placed on scheduled NSAIDs (duration to resolution and number of patients with resistant arthritis)
- Assess side effects of patients with Lyme arthritis placed on scheduled NSAIDs versus those not placed on scheduled NSAIDs
- Assess changes in resources (follow-up visits, further prescriptions) required for patients taking scheduled NSAIDs versus not taking scheduled NSAIDs
Background:
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
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthritis
- •Undergoing Lyme disease testing (Lyme test positive)
排除标准
- •Patients will be secondarily withdrawn from analysis and instructed to stop study medication if their Lyme test is negative.
- •Underlying diagnosis of rheumatoid or recurrent arthritis Already on scheduled NSAIDs
- •Anything that restricts the prescription of naproxen or acetaminophen:
- •Hypersensitivity to naproxen (for example: anaphylactic reactions, serious skin reactions) or any component of the formulation; history of aspirin induced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, underlying kidney or liver impairment
- •Already taking daily NSAIDs (naproxen or ibuprofen) or daily acetaminophen
- •Hypersensitivity to acetaminophen or any component of the formulation; severe liver impairment or severe active liver disease
研究组 & 干预措施
NSAID
Naproxen at weight based standard dose given bid daily until symptoms resolve
干预措施: Naproxen (Drug)
Acetaminophen
Acetaminophen at weight based standard dose given qid until symptoms resolve
干预措施: Acetaminophen (Drug)
NSAID first, then Acetaminophen
Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve
干预措施: Naproxen (Drug)
NSAID first, then Acetaminophen
Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Joint Pain Reported by Serial Visual Analog Scale (VAS) for Pain Via Text Surveys
时间窗: days 0(enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected
0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey
Joint Redness Reported by Serial Visual Analog Scale for Joint Redness Via Text Surveys
时间窗: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for join redness will be collected
0-100 scale (no redness to maximal redness- higher score, worse outcome), slide bar in text survey
Joint Movement Reported by Serial Visual Analog Scale for Joint Movement Via Text Surveys
时间窗: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score for joint movement will be collected
0-100 scale (no joint movement to normal joint movement- higher score, better outcome), slide bar in text survey
Overall Function Reported by Serial Visual Analog Scale for Overall Function Via Text Surveys
时间窗: days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected
0-100 scale (severely impaired function to normal function- higher score, better outcome), slide bar in text survey
Time to Complete Symptom Resolution as Collected by a Yes/no Question on the Text Survey
时间窗: Symptom resolution recorded (days 0, 1, 3, 7, 10, 14, 21, 28, 60) once they enter "yes" to symptoms completely resolved
If patient answers yes to symptoms completely resolved, the time frame from enrollment will be the days to symptom resolution
次要结局
- Medication Compliance as Determined by Question in Serial Text Survey(days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution))
- The Number of Participants With Reported Medication Side Effects as Determined by Question in Serial Text Survey(days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution))
- The Number of Participants Who Reported Taking Other Medications as Determined by Question in Serial Text Survey(days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution))
- Number of Participants Who Reported Fever as Determined by Question in Serial Text Survey(days 0 (enrollment), 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution))
研究者
Desiree Neville, MD
Assistant Professor of Pediatric Emergency Medicine
University of Pittsburgh