A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
研究概览
简要总结
This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.
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 69 Years（Adult, Older 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 Low Back Pain (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.
- •Enrollment will be limited to adults younger than 70 years because of the increased risk of adverse medication effects in the elderly.
- •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 must occur less frequently than once per month.
- •Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
- •Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire
排除标准
- •Not available for follow-up
- •Any analgesic medication use on a daily or near-daily basis
- •Allergic to or intolerant of investigational medications
- •Open wounds or skin breakdown of the lower back
- •Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR <60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)
研究组 & 干预措施
Oral ibuprofen + topical diclofenac
Oral ibuprofen 400mg Topical diclofenac 4gm
干预措施: Ibuprofen 400 mg (Drug)
Oral ibuprofen + topical placebo
Oral ibuprofen 400mg Topical placebo
干预措施: Ibuprofen 400 mg (Drug)
Oral ibuprofen + topical diclofenac
Oral ibuprofen 400mg Topical diclofenac 4gm
干预措施: Topical diclofenac (Drug)
Oral placebo + topical diclofenac
Oral placebo Topical diclofenac 4gm
干预措施: Topical diclofenac (Drug)
结局指标
主要结局
Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score
时间窗: Baseline to 48 hours
Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report 'Yes/no' instrument about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 2-day (48 hour) follow-up' with positive scores being indicative of improvement (less pain disability).
次要结局
- Frequency of Low Back Pain(7 days)
- Worst Low Back Pain (LBP)(7 days)
- Use of Medication for Low Back Pain (LBP)(7 days)
- Frequency of Low Back Pain (LBP)(48 hours)
- Return to Usual Activities(7 days)
- Number of Visits to Any Healthcare Provider(7 days)
- Treatment Satisfaction(7 days)
- Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score(7 days)