NCT05851976招募中4 期
Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of participants with moderate or severe Low Back Pain (LBP)
研究概览
简要总结
This research study will help determine whether a medication called duloxetine can improve back pain. It is well documented that many participants who come to the ER with acute low back pain still have low back pain 3 months later. The investigator team will attempt to determine whether duloxetine can help prevent this.
详细描述
Participants will be eligible to take duloxetine/placebo if insufficient relief of pain after using naproxen for 48 hours has been reported.
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)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present to Emergency Department (ED) primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.
- •Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP.
- •Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study.
- •Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in older patients.
- •Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
- •Pain duration <2 weeks (336 hours).
- •Prior to the acute attack of LBP, back pain cannot occur more frequently than once per week.
- •Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire
排除标准
- •Not available for follow-up
- •Pregnant or breast-feeding
- •Chronic pain syndrome defined as moderate or severe pain anywhere in their body on >= 50% of days for at least three months
- •Allergic to or intolerant of investigational medications
- •Contra-indications to non-steroidal anti-inflammatory drugs:
- •history of hypersensitivity to NSAIDs or aspirin
- •active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed
- •Severe heart failure (NYHA 2 or worse)
- •uncontrolled blood pressure (>160/100)
- •Glomerular Filtration Rate (GFR) <60ml/min
- •Current use of anti-coagulants
- •cirrhosis or acute hepatitis
- •Contra-indication to duloxetine:
- •alcohol use disorder
- •chronic liver disease
- •chronic kidney disease
- •Active use of medication for depression
- •Score > 10 on the Patient Health Questionnaire (PHQ-9) screening instrument or thoughts of suicide, symptoms of feeling down, depressed, or hopeless
- •PHQ9 score >
- •Now we would like to exclude patients with a PHQ9 score >10 or symptoms of feeling down, depressed, or hopeless
研究组 & 干预措施
Naproxen + duloxetine
Experimental
干预措施: Naproxen (Drug)
Naproxen + duloxetine
Experimental
干预措施: Duloxetine (Drug)
Naproxen + placebo
Placebo Comparator
干预措施: Naproxen (Drug)
结局指标
主要结局
Number of participants with moderate or severe Low Back Pain (LBP)
时间窗: 16 days, 42 days and 84 days after ED discharge
An ordinal pain scale ("severe", "moderate", "mild", or "none") will be used to assess LBP. Study participants will be asked to describe their worst back pain over the previous 24 hours. The number of patients reporting with "Moderate" or "Severe" pain will be summarized by study arm.
次要结局
- Number of Participants experiencing LBP based on the Roland Morris Disability Questionnaire (RMDQ)(9 days, 16 days, 23 days, and 42 days after Emergency Department (ED) discharge)
- Frequency of LBP(9 days, 16 days, 23 days, and 42 days after ED discharge)
- Number of visits to a healthcare provider(9 days, 16 days, 23 days, and 42 days after ED discharge)
- The number of patients experiencing Depressive Symptoms(9 days, 16 days, 23 days, and 42 days after ED discharge)
- The number of patients reporting Satisfaction with treatment(9 days, 16 days, 23 days, and 42 days after ED discharge)
研究者
研究点 (1)
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